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Abstract

Introduction: The primary objective of this study was to assess the feasibility of a 6-week internet-delivered Mantram Repetition Program (MRP) for women recently treated for breast cancer. A secondary objective explored changes in perceived stress, psycho-spiritual measures, and cytokines in the treatment group compared to a waitlist. Methods: A feasibility study (ORBIT model Phase IIa) with a randomized controlled trial pilot was conducted. Eligible women recently treated for breast cancer were randomized to the treatment group (n = 14) or a waitlist group (n = 12) and participated for 12 weeks. During weeks 1-6, the treatment group received the MRP intervention while the waitlisted group was inactive. During weeks 7-12, the treatment group was inactive while the waitlisted group received the MRP intervention. The primary outcomes were feasibility and acceptability of the internet-delivered MRP intervention protocol. Participants completed pre and post-intervention psycho-spiritual health assessments. A subset of participants provided serum for cytokine analyses at enrollment and week 6, coinciding with the period in which the treatment group receiving the MRP intervention. Results: Overall study attrition was 19.2%. MRP adherence for both groups was 86% at post-intervention and 90% in the treatment group at 6-week follow-up. Pre-to-post-intervention analyses pooling both groups’ data demonstrated decreased perceived stress (p = .045) and increased spiritual well-being (p =.004). IFN-γ and IL-17A were increased in the waitlisted group and decreased in the treatment group (p = 0.048). Conclusion: Feasibility of a 6-week, internet-delivered MRP intervention for breast cancer survivors was established. Psycho-spiritual variables and serum cytokines are suitable clinical outcome measures for future MRP studies with breast cancer survivors. Data suggest MRP may reduce perceived stress and support spiritual well-being in women with breast cancer; however, additional studies are needed.

Keywords

breast cancer immune mantram repetition program psychological spiritual stress

Highlights

• A 6-week internet Mantram Repetition Program (MRP) was feasible and acceptable to women with breast cancer.

• This article is one of the first MRP trials to include serum inflammatory cytokine measures.

• MRP may support spiritual well-being and reduce perceived stress in women with breast cancer.

Introduction

Women with breast cancer experience stress starting during the diagnostic workup for breast cancer that continues during breast cancer treatment and into survivorship.^1,2 Long-term surveillance of breast cancer survivors is necessary due to the risk of breast cancer recurrence, which is greatest during the first 5 years following treatment and most common during the first 2 years following treatment (15%).^3,4 Some survivors must navigate additional surgical procedures and complications, and many require long-term management of late effects of breast cancer treatment (e.g., lymphedema—swelling of the affected upper extremity).⁵ Subsequently, those recovering from breast cancer experience chronic symptom burdens, including depression, anxiety, ruminative thoughts, social isolation, sleep disturbances, and pain, all of which impact the quality of life.^6,7

Recognizing that breast cancer survivors are at risk for chronic perceived stress throughout the extended survivorship continuum, experts have recommended stress-reduction interventions during and after treatment for breast cancer.⁸ Consistent with psychoneuroimmunology theory, a body of literature has demonstrated that mindfulness and meditative interventions reduce stress and promote mental health in those with breast cancer.⁹ However, the effects of mindfulness and meditative interventions on immune function are not well established.

According to psychoneuroimmunology theory, the mind’s response to perceived stress initiates the hypothalamic-pituitary-adrenal axis (HPAA) and autonomic nervous system (ANS), triggering neurotransmitter and hormonal responses (eg, cortisol), which subsequently activate the immune response.^10,11 Chronic stress in those with breast cancer is associated with altered immune function and poorer survivorship.^12,13 Mindfulness and meditative interventions that reduce perceived stress appear to attenuate the inflammatory responses occurring with the hypervigilant HPAA response to perceived stress.²

Inflammatory cytokines are of particular interest in breast cancer intervention research for their complex roles in breast cancer prevention versus disease progression. For example, increased proinflammatory cytokines (IL-6, IL-8, and TNF-α) correlate with breast cancer disease stage and predict metastasis.¹⁴ IL-17A also has proinflammatory properties associated with advanced disease and poorer survival.¹⁵ Fasoulakis et al¹⁶ provides a comprehensive overview of interleukin activity in breast cancer.

Promising data from a recent randomized controlled trial (RCT) with 192 early-stage breast cancer survivors demonstrated that an 8-week mindfulness-based stress reduction (MBSR) program decreased perceived stress and mental health symptoms and improved cytokine activity (ie, lower TNF-α and IL-6, and greater IFN-γ) compared to an active education control, with perceived stress, depression, fatigue, and immune outcomes sustained at 6-month follow-up.² Another RCT with 322 breast cancer survivors (≤2 years post-treatment) demonstrated that a 6-week MBSR program had small significant effects in reduced cortisol and IL-6 compared to usual care.¹⁷

Several reviews have examined immune outcomes from mindfulness and meditative trials that included breast cancer survivors. A descriptive review by Bower and Irwin¹⁸ reported associations between several mindfulness and meditative interventions and inflammatory immune markers (eg, IL-6 and C-reactive protein); however, the authors also noted that most findings were based on underpowered samples. Our team has reported inconsistent findings between mindfulness and meditative trials and immune outcomes in breast cancer survivors primarily due to heterogeneity across trial protocols and selection of immune variables.19 More recently, a meta-analysis of the effects of mindfulness and meditative interventions on immune function reported that meditative interventions have small but significant effects on immune activity in adults with heterogeneous psychological and physiological disorders.²⁰

The Mantram Repetition Program (MRP) is a “portable” (can be done anytime and anywhere) mindfulness and meditative practice based on both Western And Eastern spiritual/religious teachings.²¹ Initially introduced as the Eight-Point Passage in the United States (US) by Sri Eknath Easwaran at the Blue Mountain Center of Meditation, Tomales, CA,^22,23 MRP teaches silent repetition of a “mantram”—a sacred or contemplative word or phrase (or holy name) chosen from one’s cultural or faith tradition to replace ruminative (worrisome) thoughts. The MRP teaches people to practice their mantram throughout the day, particularly when the mind is prone to wandering (eg, waiting in line and walking).²¹ Silently repeating a mantram interrupts rumination, focuses the mind, and initiates relaxation. While mantrams can be repeated audibly (chanted) or silently, this paper focuses on the practice of silent mantram repetition taught by the MRP.

Traditional mantrams have been used by cultural, spiritual, or faith-based groups, including secular beliefs and major faith traditions over the millennia.²¹ Among faith-based groups, mantrams facilitate a sense of spiritual connectedness to a higher power, which, in turn, offers a “self-centering” and a calming effect. The MRP is considered a mindfulness intervention because it pairs mantram repetition with mindfulness practices such as “slowing down” one’s thoughts and using “one-pointed attention” (ie, focused attention).²⁴ MRP is simple to teach and learn; therefore, there are few costs associated with implementing it in the clinical setting. More details about MRP can be found in Oman et al.²¹

Two psychological mechanisms associated with MRP, “focus-shifting” and “frame activation,” are discussed in detail in Oman^21,25 and Bormann et al.²⁶ Briefly, “focus-shifting” occurs with mantram practice as one shifts attention away from ruminative thoughts.²¹ With regular practice, mantram repetition facilitates the activation of “adaptive, coping-supportive mental frameworks” (p. 1421) that promote resilience.²¹ Randomized studies have shown that the MRP significantly enhances mindful attention, which mediates some benefits, including reduced posttraumatic stress symptoms and depression and improved psychological well-being.²⁷ Like other mindfulness approaches, MRP emphasizes awareness of the present moment and acceptance.²¹ A more in-depth discussion of the psychological mechanisms of mantram repetition is discussed by Oman.²⁵

A recent systematic review of 22 MRP trials reported that MRP improves psychological symptoms, including depression, anxiety, insomnia, and perceived stress.28 The review also reported that MRP had been delivered to diverse adult clinical populations, including combat veterans,^29,30 people with HIV,²⁶ homeless women,³¹ healthcare professionals,²⁴ college students,³² older healthy adults,³³ heterogeneous cancer survivors.³⁴ Additionally, MRP has been delivered using a variety of approaches (ie, groups, individuals, teleconference, and videoconference) using in-person, 60 to 90-minute, weekly group classes for 5 weeks,²⁶ 6 weeks,^30,35 or 8 weeks.²⁹

Functional magnetic resonance imaging (fMRI) has shown that silent mantram repetition suppresses the default mode network activity responsible for ruminative thoughts.³⁶ Except for a study by Bormann et al³⁷ examining the effect of MRP on salivary cortisol, very few studies have examined the effects of MRP on physiological outcomes. Moreover, except for a study by Yong et al³⁴ that demonstrated improved spiritual well-being and decreased anxiety and depression in South Korean cancer survivors (N = 61), few studies have examined the benefits of MRP in an oncology population. To our knowledge, this paper is one of the first to report on silent mantram repetition (ie, MRP) in American women with breast cancer and one of the first reports to include inflammatory cytokine measures.

The Obesity-Related Behavioral Intervention Trials (ORBIT) Model provides a framework for intervention development and refinement, which suggests assessing the feasibility of a fixed protocol before proceeding to a fully powered trial.³⁸ Thus, this paper reports our findings from our recent ORBIT Model Phase IIa study, the primary objective of which was to assess the feasibility and acceptability of adapted internet-delivered MRP RCT for women recently treated for breast cancer. Our central hypothesis was that the 6-week internet-delivered MRP would be feasible and acceptable to breast cancer survivors. Our secondary research questions explored potential changes in psycho-spiritual variables (perceived stress, rumination, anxiety, sleep disturbance, fatigue, and spiritual well-being) and inflammatory cytokines.

Method

Participants

Eligible participants were females between ages 21 to 80 years of age, treated for breast cancer between 2018 and 2021, stages 0 to IIIa, and at least 2 months post-treatment (any combination of surgery, chemotherapy, and radiation). Excluded females were those who were regular mindfulness-meditation practitioners, receiving chemotherapy, cognitively impaired, or on immunosuppressant treatments. We also excluded those currently participating in other mindfulness-meditative or stress-reduction studies or who engaged in a regular mindfulness-meditative practice more than once a week. Because ORBIT Model Phase IIa feasibility studies use small samples to assess proof of concept of the study components before proceeding to a full-scale RCT, a power analysis to determine sample size was not indicated.³⁸ The sample size was based on the primary outcome of assessing the feasibility and acceptability of a newly adapted MRP internet-based intervention for women with a breast cancer history.

The participants were all female. As shown in Table 1, the typical participant was white (96.2%), ages 40 to 49 years (46.2%), breast cancer stage 1 (53.8%), married (65.4%), postmenopausal (73.1%), and all had received surgical treatment for breast cancer. Most women were hormone receptor-positive (59%). Consistent with our screening protocol, none of the participants were engaged in a daily mindfulness-meditative practice or had previously practiced a mindfulness-meditative practice regularly. The exception was yoga; several participants reported infrequently practicing yoga once per week or less often.

Table 1.

Sample Characteristics at Enrollment (N = 26).

Characteristic	Treatment group	Waitlist group	Total	Percent
Characteristic	N = 14	N = 12	Total	Percent
Age (y)
30-39	0	2	2	7.7
40-49	8	4	12	46.2
50-59	3	2	5	19.2
60-69	2	3	5	19.2
70-80	1	1	2	7.7
Race
Asian	0	1	1	3.8
White	14	11	25	96.2
Breast cancer stage
0	0	2	2	7.7
I	6	8	14	53.8
II	4	1	5	19.2
III	2	1	3	11.5
Unknown	2	0	2	7.7
Breast cancer recurrence: (yes)	0	2	2	7.7
Lymphedema: (yes)	3	3	6	23.1
Surgery: (yes)	14	12	26	100
Radiotherapy: (yes)	9	7	16	61.5
Chemotherapy: (yes)	9	5	14	53.8
Postmenopausal: (yes)	8	11	19	73.1
Elapsed time post-treatment
2-5 mo	2	1	3	11.5
6-11 mo	4	2	6	23.1
1 y	3	5	8	30.8
2 y	3	2	5	19.2
3 y	2	2	4	15.4

Study Timeline and Terminology

Each participant was in the study for 12 weeks. We used a rolling recruitment and delivery of the group conditions in that as participants were recruited, they could immediately complete enrollment, consent, randomization, initial psycho-spiritual assessments and lab draws (optional) and begin their participation the following week. This 1-week period between recruitment and starting participation is referred to as “Week 0.”

As shown in Table 2, Week 0 was also the pre-intervention time point for the treatment group that received the MRP intervention during Weeks 1 to 6. At the end of Week 6, the treatment group completed post-intervention assessments and was inactive during Weeks 7 to 12. The treatment group then completed 6-week post-intervention follow-up assessments in Week 12.

Table 2.

Timeline of Assessments for the Treatment Group (TG) and Waitlist (WL) Group.

Variables	Week 0	Week 1	Week 6	Week 7	Week 12
Variables	Enrollment & TG pre-intervention		TG post-intervention & WL pre-intervention		TG 6-wk follow-up & WL post-intervention
Demographics	All	-	-	-	-
Medical history	All	-	-	-	-
Intervention history	All	-	-	-	-
Primary outcomes (feasibility)
MRP adherence questionnaire	-	-	TG	-	All
MRP practice log	-	Weekly for 6 wk (TG only)		Weekly for 6 wk (WL only)
SUS	-	-	TG	-	All
Narrative feedback	-	-	TG	-	All
Secondary outcomes
PSS	All	-	All	-	All
RRS	All	-	All	-	All
PROMIS-57	All	-	All	-	All
FACIT-Sp-12	All	-	All	-	All
Cytokines (n = 9)	All	-	All	-	-

During weeks 1 to 6, the Treatment group received the MRP intervention while the waitlisted group was inactive. During weeks 7 to 12, the Treatment group was inactive while the waitlisted group received the MRP intervention.

Abbreviations: FACIT-Sp, functional assessment of chronic illness therapy-spiritual well-being; MRP, mantram repetition program; PSS, perceived stress scale; PROMIS, patient reported outcomes measurement information system; RRS, ruminative responses scale; SUS, system usability scale.

The waitlist group served as a comparison group during Weeks 1 to 6 by completing an initial set of assessments at enrollment (Week 0) and then remaining inactive during Weeks 1 to 6. During Week 6, the waitlist repeated psycho-spiritual assessments, and these were considered their “pre-intervention” assessments. The waitlist group received the MRP intervention during Weeks 7 to 12 and completed their post-intervention assessments at the end of Week 12. In summary, Weeks 0 and 6 were the pre-to-post-intervention time points for the treatment group, and Weeks 6 and 12 were the pre-to-post-intervention time points for the waitlisted group.

Procedures

Recruitment

The design was a feasibility pilot RCT with a waitlist comparison group. The setting was a midwestern US academic health science center with a multidisciplinary cancer center. The University of Missouri Institutional Review Board approved the study. Participants were recruited during a 12-month rolling period (spring 2021 through spring 2022) through oncology clinic referrals, a study website, social media, study fliers, and breast cancer survivorship groups. We invited study participants to complete in-person visits for 2 blood draws at enrollment (Week 0) and 6 weeks later (Week 6). However, visits for blood draws were made optional because the study occurred during the peak of the COVID-19 pandemic, and our primary outcome was the feasibility of the internet-delivered intervention. All participants provided informed consent. No adverse events were reported during the study.

Randomization and masking

Participants were stratified by menopausal status (premenopausal versus postmenopausal) and breast cancer stage (stage 0-I versus stages II-IIIa). Then, a computer-generated 1 to 4 sequence within each block was used to randomize participants to the treatment group (n = 14) or the waitlisted group (n = 12) (see Figure 1). The project director notified participants of their group assignments. Research assistants and team members were unaware of the randomization sequence. Further, the statistician was unaware of participants’ identities and group assignments.

Figure 1.

Participating at post-intervention (Week 6) (n = 11) Participating at 6-week post-intervention follow-up (Week 12) (n = 10).

Because participants participated individually, asynchronously, and online, the delivery of the treatment and the waitlist group conditions occurred on a rolling basis, in which participants began their respective group’s assignment immediately following randomization. The asynchronous and rolling delivery did not allow for participants to interact with each other; thus, participants were unaware of other study participants. Self-reported data were deidentified using Hekademeia Sub Rosa software with Qualtrics surveys; therefore, the assessors were also unaware of data corresponding to participants’ identifying information.³⁹ To enhance the validity of the findings, we partially concealed the intervention type by generically describing the study as a mindfulness study in study materials.

Retention

The retention strategy included automated twice-weekly emails and gift card incentives at specific time points. All participants also received customized “check-in” emails from the study team at the mid-point while receiving the MRP intervention to inquire how the participant was doing with the intervention activities. Participant compensation was US$75. Participants who provided serum received an additional US$100 for a total compensation of US$175.

MRP Intervention

We adapted the MRP intervention from an existing, standardized MRP curriculum described in the introduction. The rationale for a 6-week MRP intervention was based on literature that the MRP is associated with mental health benefits whether delivered at 5, 6, or 8 weeks.28 We also considered that behavioral interventions with longer durations pose an attrition risk, while shorter durations may not be adequate for adopting the new skill. Subsequently, 6 weeks was anticipated to provide the necessary time to support participants’ intervention uptake while minimizing attrition risk.

Website

A study website was created for advertisement, recruitment, and initial screening, and 4 MRP videos were provided to support MRP learning. For interested readers, these MRP videos are free and publicly accessible through PsychArmor®.⁴⁰ The website included a video introduction of MRP, a testimonial video, 4 short MRP videos (8-14 minutes), and a list of recommended mantrams. For complete intervention details and recommended mantrams, see Tables S1 and S2. Further, the mantrams listed in Table S2 qualify as traditional mantrams discussed by Oman.²⁵ Although the MRP videos are not required for learning MRP techniques, the videos reinforce participants’ learning and facilitate continued utilization of MRP techniques. The videos are short enough that one-time viewing is sufficient for understanding; however, participants may watch the videos again. Two “comprehension” survey questions followed each video, which allowed us to assess whether participants viewed and understood the content.

Sub Rosa software³⁹ automated and coordinated uniform delivery of the MRP intervention content via twice-weekly emails for 6 weeks (See Figure 2). Thus, all participants received the same MRP intervention content (ie, videos and emails with instructions) using the same delivery method, at the same pace, and by the same facilitator on the MRP videos. Intervention fidelity was examined by the extent to which participants correctly answered the 2 video comprehension questions following each video.

Figure 2.

Intervention flow diagram.

An introductory email provided participants with an overview of the study and instructions on accessing the study website. During week 1 of the MRP intervention, participants watched video one, selected and practiced a mantram 4 times daily (morning, midday, early evening, and bedtime) for at least 2 minutes each time (ie, the “dose”) and longer if they chose. Video 1 instructed participants in selecting a mantram and how and when to use the mantram (eg, while performing daily activities like standing in line, walking, or sitting in traffic). Subsequent weekly videos taught additional mindfulness skills, including learning to slow one’s thoughts (being nonjudgmental) in week 2 and engaging in focused attention in week three. The week 4 video instructed participants on putting all the concepts together. Weeks 5 and 6 instructed participants to practice their mantrams without any additional content presented.

Treatment group

Participants in the treatment group started receiving the MRP intervention immediately on the Monday following enrollment, randomization, and psycho-spiritual assessments. Twice-weekly emails were sent on Mondays and Thursdays to facilitate participants’ engagement. Monday emails reminded participants to practice their mantrams and track their frequencies of daily practice (how many times they initiated mantram practice per day). Thursday emails included a thank you for ongoing participation, a weekly inspirational quote (to match co-occurring waitlist emails), and a Qualtrics survey link to collect participants’ daily mantram practice log totals for the previous week. During the third week of the intervention, the study team “checked in” with participants by email to inquire about how the participants were doing. At post-intervention, participants repeated psycho-spiritual assessments, completed usability and MRP adherence assessments, and offered narrative feedback. During Weeks 7 to 12, the treatment group commenced an inactive period and did not receive any formal instructions to practice MRP techniques because we wanted to assess the extent to which participants continued using MRP of their own accord. For retention purposes, the treatment group continued to receive twice-weekly emails thanking them for their participation (on Mondays) or inspirational quotes (on Thursdays). Treatment group participation concluded at the end of Week 12 after repeating psycho-spiritual, usability, and MRP adherence assessments and offering narrative feedback.

Waitlisted group

Like the treatment group, delivery of the waitlisted group occurred on a rolling basis, with a Monday start following enrollment and initial psycho-spiritual assessments in Week 0. Each waitlisted participant received an initial email providing an overview of their participation and then commenced 6 weeks of inactivity (ie, Weeks 1-6), during which they received twice-weekly emails. Monday’s emails thanked participants for being in the study and reminded them of their progression in the study timeline. Thursday’s emails provided the same inspirational quote that the intervention group received. After an initial 6-week waiting period, waitlisted participants repeated psycho-spiritual assessments and were offered the MRP intervention during Weeks 7 to 12. At post-intervention (the end of week 12), waitlisted participants repeated psycho-spiritual assessments, completed usability and MRP adherence assessments, offered narrative feedback which concluded their study participation.

Primary Outcomes

Our primary outcomes were feasibility criteria reported by Bowen et al⁴¹ which consist of a list of guiding questions to evaluate acceptability, demand, implementation, and practicality. Bowen et al’s feasibility criteria are well-established and highly cited in the research literature. Participants also completed a demographic questionnaire at enrollment reporting population demographics (eg, age, race, ethnicity) and clinical treatment histories (eg, breast cancer stage, treatment, and co-morbidities).

Acceptability examined how the participants reacted to the intervention.⁴¹ We examined rates of enrollment rates, attrition rates, and narrative feedback from participants about their satisfaction with the intervention and study procedures.

Demand refers to evidence that participants readily participated in the intervention (eg, practice data and data suggesting continued utilization and website analytics).⁴¹ Participants tracked their daily mantram practice sessions (ie, the number of times a practice session was initiated each day and for how long). They reported their practice data in a weekly Qualtrics survey email (Participants were asked to practice for at least 2 minutes per session.). Continued utilization of the MRP intervention was examined post-intervention using a Mantram Adherence questionnaire, which included 7 items assessing mantram practice over the past 7 days. Four items asked about continued MRP skills practice, and 3 asked about practice frequency.²⁹ Bormann et al⁴² reported that self-reported mantram practice highly correlated (r = .84) with objective measures of tracking mantram practice (ie, wrist-worn counters). Finally, we examined website analytics to prove that participants accessed the study’s videos.

Implementation was operationalized based on the ability to implement the intervention as planned.⁴¹ In this regard, we examined the completeness of assessments across time points and website usability which was assessed using The System Usability Scale (SUS)^43,44 at post-intervention. The SUS is a validated instrument using a 10-item Likert scale that allows users to evaluate the technological use of software, mobile device links, and website navigation. Examples of questions included: (1) I think I would like to use this website frequently; (2) I thought the website was easy to use; and (3) I found the website very cumbersome to use. The SUS has demonstrated acceptable reliability (r = .82) in small samples.⁴⁵ Scores are converted to percentile rankings; a usability percentile ranking greater than 60% indicates acceptable usability of the technology.⁴⁵

Practicality focused on whether the intervention could be delivered given the available resources (eg, time, cost, and participant burden).⁴¹ Additionally, practicality includes consideration for unexpected costs to delivering the intervention. This study primarily assessed practicality using participants’ narrative feedback at post-intervention. Open-ended questions included: (1) Would you like to share any thoughts about your experiences with this study? (2) Is there anything about the study that you feel could be improved? (3) What was your favorite aspect (if any) about being in this study? (4) Would you recommend any information or techniques learned in this study to a friend, and (if yes) () What kind of information would you envision sharing with others?

Secondary Outcomes

The Perceived Stress Scale (PSS) is a 10-item questionnaire measuring general perceived stress over the past month.⁴⁶ The PSS has demonstrated acceptable reliability (McDonald’s omega ranging from 0.73 to 0.87) in people with breast cancer.⁴⁷ Scores range from 0 to 40. Higher scores indicate more perceived stress; a score ≥14 indicates at least moderate levels of perceived stress.⁴⁸

The Ruminative Responses Scale (RRS) is a 22-item questionnaire measuring ruminative tendencies about a stressful event. The RRS has adequate reliability (Cronbach’s α = .85); higher scores indicate greater tendencies toward rumination.⁴⁹ Scores range from 22 to 88; higher scores indicate more ruminative thoughts.

Patient-Reported Outcomes Measurement Information System (PROMIS®) v1.0 questionnaires measured Anxiety—8a, Fatigue—8a, and Sleep Disturbance—8a. PROMIS® profile measures have demonstrated high reliability (r ≥ .9 for anxiety, fatigue, and sleep disturbance short-forms) and construct validity consistent with general health and quality of life measures.⁵⁰ All questionnaires have 8 items each. For each questionnaire, raw scores were converted and reported as T-scores, with a score of 50 being the average for the US general population with a standard deviation of 10. Higher PROMIS-57 T-scores represent more of the concept being measured.⁵⁰

The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) is a 12-item questionnaire measuring spiritual well-being, meaning, peace, and faith over the past 7 days. Scores range from 0 to 48; higher scores indicate greater perceptions of spiritual well-being.⁵¹ The FACIT-Sp-12 has demonstrated high reliability (McDonald’s omega 0.90) and Cronbach’s alpha (.89).⁵²

Commercially available multiplex kits allow for testing multiple inflammatory cytokines using customized panels. Eight cytokines, including interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, IL-17A, tumor necrosis factor-alpha (TNF-α), and interferon-gamma (INF-γ), were measured. The laboratory scientists who conducted the immunoassay procedures were blinded to participants’ groups.

Data Collection and Data Analyses

The timeline of data collection of assessments and blood draws is shown in Table 2.

Blood draws

A subset of 9 participants (treatment n = 3; waitlist n = 6) provided blood at Week 0 and Week 6. Registered nurses employed by a clinical research center laboratory performed the venipunctures. Blood draws occurred mid-morning to control for diurnal fluctuations of cytokines. Participants provided 12 mL of blood using 2 serum separator tubes. Specimens were clotted for 30 minutes and centrifuged for 10 minutes at 1500g. Serum was harvested, aliquoted into polypropylene tubes, and frozen at −80°C within 30 minutes. Serum samples were analyzed for cytokine concentrations by the team’s immunology bench science experts using a multiplexed Milliplex Human High Sensitivity T Cell Magnetic Bead panel (EMD Millipore) and a Luminex MAGPIX analyzer. Analytes (lower limits of detection in pg/mL in parentheses) included in the panel were (IL)-2 (0.19), IL-4 (1.12), IL-6 (0.11), IL-8 (0.13), IL-10 (0.56), IL-17A (0.33), TNF-α (0.16), and IFN-γ (0.48). Serum was thawed on ice and centrifuged at 10 000g for 5 minutes at 4°C to remove insoluble material. Serum (25 µL) and assay buffer (25 µL) were added to 25 µL of the magnetic capture beads in 96-well plates and incubated with shaking overnight at 4°C in the dark. Standards were prepared according to the manufacturer’s instructions. Samples and standards were plated in duplicate. Following 3 washes, 50 µL of detection antibody was added for an hour. Streptavidin-phycoerythrin detection reagent (50 µL) was added, and after 3 washes, median fluorescent intensities for each bead population in each well were measured. Analyte concentrations were calculated using the standard curves. The intra-assay coefficients of variance (CVs) were less than 15% for all analytes included in the analysis. The IL-2 analyte concentrations were below the lower limit of detection (all concentrations ≤ 0.09 pg/mL) and were thus not used for analysis.

The intent-to-treat analysis included all randomly assigned participants who provided post-intervention data, regardless of MRP adherence. Statistical analyses were conducted using SPSS version 27. Descriptive statistics (mean, standard deviation, the interquartile range for interval and ratio variables, and count and percentage for nominal or ordinal variables) were used to examine participants’ characteristics and measurements overall and by group. At Week 0, Levene’s test for equality of variances demonstrated homogeneity of variances for perceived stress, ruminative responses, anxiety, fatigue, sleep disturbance, and spiritual well-being, all p’s >.05. Independent t-tests for equality of means demonstrated a statistically significant difference between group scores for only perceived stress (P = .04) at Week 0, showing that perceived stress was greater in the treatment group at enrollment.

Wilcoxon-matched paired tests were conducted to examine the change from Week 0 to Week 6 on each group’s psycho-spiritual assessments and blood draws during the time the treatment group received the MRP intervention, and the waitlist was inactive. By Week 12, the waitlisted group had also received the MRP intervention; therefore, we combined and analyzed their pre and post-intervention data (N = 21) based on each group’s pre and post-intervention time points as shown in Table 2. Additional details are discussed when the results are presented.

Primary Results

Acceptability

During a 12-month rolling recruitment period, 52 people inquired about the study. As shown in Figure 1, 9 people were ineligible, and 17 declined to participate. The remaining 26 people enrolled (50%) and were randomized to the treatment group (n = 14) or the waitlist group (n = 12).

Three participants randomized to the treatment group had dropped by Week 6; however, these dropouts occurred before participants started the intervention (21.4% attrition). Reasons for attrition were time constraints (2 people); one person completed the pretest and then was lost to follow-up. Of those still participating in the treatment group at post-intervention (n = 11), 100% reported they would recommend the MRP techniques to other people.

None of the waitlisted participants dropped during their first 6 weeks of inactivity. Therefore, 23 individuals (treatment n = 11; waitlist n = 12) were still participating at the end of Week 6, corresponding to the time the treatment group reached post-intervention (ie, zero attrition among those who started participation) and before the waitlist received the intervention.

By Week 12, 2 waitlisted participants had dropped halfway through the MRP intervention for unknown reasons (16.7% attrition). For both groups combined, a total of 5 participants dropped resulting in an overall attrition rate of 19.2% at post-intervention. One treatment group participant did not complete the 6-week post-intervention follow-up surveys at Week 12. Week 12 assessments coincided with the winter holiday season and summer vacation season, which may partially account for attrition. Subsequently, 21 participants provided complete pre-to-post-intervention data (treatment n = 11; waitlist n = 10). Finally, narrative feedback from 17 participants at the end of Week 12 revealed that 95% of participants would recommend the MRP techniques to others and several participants had already shared MRP techniques with others.

Demand

Website analytics demonstrated that 23 participants accessed the MRP intervention videos at rates ranging from 65% to 83% (We note that the videos were not required for learning and were supplemental only.). The percentage of participants correctly answering video comprehension questions were Video 1 (83%), Videos 2 and 3 (100%), and Video 4 (74%).

MRP practice adherence rates are presented in Table 3. Because both groups (N = 21) ultimately received the MRP intervention, participants’ practice reports were pooled and analyzed for adherence using each group’s immediate post-intervention time point, as shown in Table 2. At post-intervention, 86% of participants reported they were still using their mantram an average of 4.3 times per day on 5.6 days of the past 7 days. At 6 weeks post-intervention follow-up (ie, Week 12), 90% of the treatment group (n = 10) reported using their mantrams an average of 2.9 times per day on 4.9 days of the past 7 days.

Table 3.

Mantram Repetition Program (MRP) Adherence.

Variable	Post-intervention^a	6 wk Follow-up^b
	(TG + WL)	(TG only)
	(n = 21)	(n = 10)
	M (SD)	M (SD)
During the past 7 d, please enter the number of days you practiced mantram.	5.57 (2.42)	4.90 (2.28)
During the past 7 d, how many mantram sessions did you initiate each day?	4.29 (6.12)	2.85 (2.77)
During the past 7 d, how many nights did you practice mantram?	4.81 (2.29)	4.20 (2.78)
	% Yes	% Yes
Are you still using mantram?	86	90
Are you using a mantram when you do not need it?	71	60
Are you practicing slowing down?	86	80
Are you practicing one-pointed attention?	81	70

Post-intervention refers to the period immediately following when each group had received the MRP intervention.

Only the treatment group completed 6-week post-intervention follow-up assessments; these assessments occurred at the end of Week 12.

Implementation

Implementation was evaluated in 2 ways. First, we assessed the feasibility of our MRP intervention procedures to conduct a future randomized controlled trial. In this regard, we examined the percentage of participants completing all assessments at each time point and observed that completeness of data collection was 96% at Week 0, 85% at Week 6, and 74% at Week 12. Blood draws at Week 0 and Week 6 were completed at 100%. Additionally, we observed that in Week 6, the treatment group rated the study website usability at 75%, and both groups rated the study website at 81% in Week 12. Second, we considered the feasibility of the MRP intervention itself based on participants’ adherence to MRP practice, as shown in Table 3.

Practicality

We did not experience any unexpected costs when delivering the MRP intervention. Although we utilized a study website for research purposes, the MRP videos are widely available at PsychArmor.org.⁴⁰ MRP is simple to teach and learn; therefore, MPR has no associated costs and is practical for internet-delivery which allows wider accessibility to rural individuals and those who are location-bound. Additionally, since MRP does not require any equipment and can be practiced anytime and anywhere, it offers the potential for being a sustainable practice that can be integrated into busy daily lives.

Practicality was evaluated by participants’ narrative feedback regarding limitations in participating in the study, including suggestions for improvement. At Week 6, 3 treatment group participants suggested adding more faith tradition mantram choices (eg, Christian) and a weekly video using mantram as a guided meditation. One participant reported concern about tracking the twice-weekly emails and ensuring they received all communications.

At Week 12, 10 participants (treatment and waitlist) offered suggestions that they would have liked to have had more support materials (eg, videos and books). Participants also suggested providing more choices of faith tradition mantrams and more interactive activities. A few comments were related to the intervention design. For example, one participant expressed frustration with tracking mantram practice. One participant received duplicate weekly emails. Another participant preferred to create their mantram rather than use one from the traditional mantram list provided.

Participants were asked whether they would like to share any thoughts about their experiences with the study. At Week 6, treatment participants commented that they enjoyed learning about mantram techniques (eg, slowing down practices) and learning new ways to cope with anxiety. Most participants were unfamiliar with MRP before being in the study. Several participants reported that MRP helped them relax and improved their sleep. Others reported that helping future breast cancer survivors by being in the study was important to them.

At study conclusion, 17 participants commented on their experiences of being in the study. Most participants’ comments were positive (95%), indicating that participants enjoyed learning a new skill and that the mantram helped them feel more peaceful, calm, and relaxed. One participant wrote, "Before this [study], I never realized how not present I was in my life, let alone how much worse I had gotten after [breast cancer] diagnosis.” Several participants stated plans to share MRP techniques with friends and family and to continue their mantram practices after the study ended.

Negative comments included one participant who did not like the psychological assessments (ie, stress and rumination), nor did they like tracking mantram practice. Another participant commented negatively and positively, stating that while it was challenging to remember to practice the mantram, using the mantram at bedtime improved her sleep.

Comments regarding what participants liked or disliked about MRP included, “the mantram was helpful in falling asleep,” “learning a new mindfulness technique,” “it made me think about what my body is doing,” “learning and practicing the mantram,” “practicing slowing down,” “trying something different,” and “simply the idea of it, and the emphasis on how mental health/ relaxation techniques and positive thinking can impact our well-being. . .” In summary, themes from the narrative feedback indicated that participants perceived benefits of practicing mantram, including better sleep, less anxiety and fear, and feeling more peaceful.

Secondary Results

Psycho-spiritual variables

Pooled analyses of both groups’ pre-intervention psycho-spiritual scores (N = 21) were compared to their corresponding post-intervention scores. As shown in Table 4, perceived stress scores decreased from pre-to-post-intervention (P = .045), while spiritual well-being scores increased (P = .004). Pre-to-post-intervention changes were observed for rumination, anxiety, sleep disruption, and fatigue; however, these changes were not statistically significant.

Table 4.

Changes in Psychological-Spiritual Scores: Pre-to-Post-intervention for Both Groups Combined.

Variables^a	Pre-intervention	Post-intervention	P ^b
(N = 21)	M (SD)	M (SD)	P ^b
Perceived stress	15.4 (6.8)	13.4 (4.2)	.045 *
Rumination	38.1 (13.6)	36.3 (10.9)	.290
Anxiety	55.4 (9.0)	54.7 (6.5)	.550
Sleep disturbance	53.9 (6.4)	52.7 (4.3)	.270
Fatigue	52.3 (12.1)	53.4 (8.7)	.390
Spiritual well-being	30.5 (13.1)	34.1 (10.3)	.004 *

For all variables except spiritual well-being, a decrease from pre-to-post-intervention indicates improvement, whereas, for spiritual well-being, an increase indicates improvement.

Probability values reflect changes for all participants from pre-to-post-intervention using Wilcoxon-matched paired tests.

P < .05.

We also examined within-group changes in psycho-spiritual variables for the treatment group and the waitlisted group during the period the treatment group was actively receiving the intervention, and the waitlisted group was inactive (Week 0 to Week 6). As shown in Table S3, the treatment group reported decreases in perceived stress at post intervention (P = .025) compared to a small decrease in the waitlisted group (P = .893). Spiritual well-being had a statistically significant increase in the treatment group (P = .007), while the waitlist change was not statistically significant (P = .765). From Week 0 to Week 6, the waitlist group experienced more sleep disturbances (P = .026). In contrast, the treatment group showed a decrease in sleep disturbances (P = .248); however, these changes were not statistically significant.

Cytokines

Mean differences in cytokine concentrations by group were evaluated using Mann-Whitney U tests (see Table 5). An extreme outlier for IL-4 was removed for statistical analysis. At Week 6, across all cytokines, changes in the treatment group ranged from 24% to 71%, while changes in the waitlist group ranged from 1% to 34%. Further, only IL-17A and IFN-γ demonstrated statistically significant changes over time (both P = .048), decreasing in the treatment group and increasing in the waitlist group.

Table 5.

Group Changes in Cytokines from Week 0 to Week 6.^a.

Cytokine concentrations (pg/mL)	GroupWL (n = 6)TG (n = 3)	Week 0M (SD)	Week 6M (SD)	Percent change (%)	DirectionIncrease (+)Decrease (−)	P ^b
IL-4^c	WL	9.89 (15.77)	6.53 (10.36)	34	-	.786
IL-4^c	TG	1.48 (0.49)	1.12 (0)	24	-	.786
IL-6	WL	7.77 (16.01)	7.73 (15.72)	1	-	.548
IL-6	TG	0.34 (0.29)	0.11 (0.01)	68	-	.548
IL-8	WL	19.70 (35.21)	19.50 (35.30)	1	-	.262
IL-8	TG	3.56 (1.46)	2.18 (1.19)	39	-	.262
IL-10	WL	13.97 (17.23)	11.87 (18.20)	15	-	.714
IL-10	TG	2.38 (2.02)	1.23 (0.38)	48	-	.714
IL-17A	WL	2.20 (1.7)	2.34 (1.82)	6	+	.048 *
IL-17A	TG	4.16 (0.76)	2.48 (1.51)	40	-	.048 *
TNF-α	WL	2.73 (1.61)	2.43 (0.88)	11	-	.167
TNF-α	TG	3.26 (1.05)	2.28 (1.01)	30	-	.167
IFN-γ	WL	2.33 (1.79)	2.68 (2.03)	15	+	.048 *
IFN-γ	TG	2.77 (2.95)	0.81 (0.44)	71	-	.048 *

Week 0 to Week 6 is when the treatment group received the MRP intervention, and the waitlisted group was inactive.

Probability values reflect differences in mean scores from Week 0 to Week 6.

For IL-4, the waitlist was (n = 5) due to removing one extreme outlier.

Abbreviations: IFN-γ, interferon-gamma; IL, interleukin; pg/mL, picogram per milliliter; TNF-α, tumor necrosis factor-alpha; TG, treatment group; WL, waitlist group.

P < .05.

Discussion

Our pilot RCT confirmed the feasibility and acceptability of delivering an asynchronous, 6-week internet MRP intervention to Midwestern US women with breast cancer. Previous stress-reduction studies with breast cancer survivors include many MBSR and yoga trials that require dedicated space, facilitators, and materials or equipment for implementation. However, whether research participants adhere to mindfulness and meditative interventions once study activities conclude remains unknown.⁵³ One of our ongoing motivations to study a scalable mindfulness and meditative intervention like MRP was that clinical recommendations for effective practices to reduce stress are more likely to be sustainable when they are simple and easily integrated within busy lifestyles. Our rural Midwestern cancer center’s catchment area includes the rural portions of adjacent states in which cancer patients often drive at least 1 hour (one-way) for treatment, follow-up appointments, and supportive care (including stress-reduction classes). Subsequently, rural breast cancer survivors experience a burden of participation in not only research but also in receiving supportive care that is only offered at the cancer center. While Midwestern rural areas do have fitness centers, there are membership costs, and facilitators’ skills are variable.

Commercially available mindfulness and meditation apps like Headspace and Calm offer scalability for internet delivery; however, few empirical articles have reported the immune responses associated with using mobile apps. Thus, there remains a need for more research examining the efficacy of internet-delivered mindfulness and meditation interventions on immune outcomes in breast cancer survivors.

Our findings confirmed our central hypothesis that a 6-week internet-delivered MRP was feasible and acceptable to breast cancer survivors. Our attrition rate (13%) in the treatment group was in line with attrition rates of in-person group-delivered MRP trials (average 17.6%). One of the largest, full-scale MRP trials (n = 173 veterans) to date reported 22% attrition in the MRP treatment group compared to 14% in the control condition (patient-centered therapy); however, attrition did not differ significantly between the MRP treatment group and the control condition.²⁹ Attrition rates were lower for in-person delivery than those for technology-delivered methods (eg, teleconference and virtual delivery); however, few technology-delivered studies exist, limiting comparisons.28

Few MRP trials have been conducted with breast cancer survivors, and even fewer MRP trials have occurred with a Midwestern US sample. Another research team recently completed a 4-week internet-delivered MRP for 60 undergraduates using a similar protocol to our 6-week protocol.⁵⁴ The primary difference was that we allowed 2 additional weeks of continued MRP practice data before obtaining post-intervention assessments. Vannini et al⁵⁴ demonstrated high retention with their internet MRP study, with 88% completing all 4 video modules and 77% completing 1-week follow-up questionnaires. Additionally, participants were diverse: 50% female, 37% Asian, 21% Latinx, 19% White, and 17% were international citizens.⁵⁴

Our data offer preliminary support to the findings of other MRP studies reporting reductions in perceived stress in individuals with HIV,²⁶ older adults,³³ health professionals,²⁴ and college students.³² Likewise, we observed statistically significant improvements in spiritual well-being, consistent with other MRP trials.^26,30 Although underpowered, the clinical implications of this study suggest that MRP shows promise for decreasing rumination, anxiety, and sleep disturbance.

Group changes spanning the time that the treatment group was active, and the waitlist was inactive demonstrated negligible changes in the waitlist group compared to statistically significant improvements in the treatment group for perceived stress, sleep disturbance, and spiritual well-being. Additionally, sleep disturbance and fatigue tended to worsen in the waitlist compared to the treatment group over this same time. The clinical implications from our data suggest that the MRP intervention may offer psycho-spiritual benefits to breast cancer survivors, although more data are required.

We observed greater cytokine changes in the treatment group from Week 0 to Week 6 compared to the waitlist. While this study was underpowered for statistical significance, signals in the data suggested that these cytokines (except for IL-2, in which all samples were below the lower limit of detection for the assay) are reasonable clinical outcome measures for consideration in future full-scale studies. Although changes in 2 proinflammatory cytokines, IFN-γ and IL-17A, were significantly increased in the waitlist and decreased in the treatment group over time, future studies are needed to determine whether these changes are biologically important or clinically relevant with the clinical implication that the MRP intervention may support immune health in women with breast cancer. A longitudinal design with a larger sample is required to confirm these observations.

Limitations and Future Research

This feasibility RCT utilized an underpowered design; subsequently, a larger sample is necessary to evaluate the clinical findings fully. Challenges in recruiting during the peak of the COVID-19 pandemic further limited our design in terms of exploring our immunological outcomes with more participants. Eligible participants were recruited from a single study site, which limited the diversity of the sample to mostly white, Judeo-Christian women based on regional demographics. Likewise, the inclusion of only women precludes our ability to consider how sex and gender influence our findings. A sample with more diverse population demographics is necessary to understand the acceptability of MRP to survivors of breast cancer from diverse cultural groups. We utilized a waitlist comparison in the current study; however, an active control group would strengthen the design rigor for future full-scale studies.

The treatment group reported moderate levels of perceived stress at enrollment compared to lower perceived stress scores among the waitlist group. Differences in perceived stress scores could be addressed in future studies with breast cancer survivors by including a cutoff for perceived stress scores to the inclusion criteria or stratification during randomization. The treatment group was evenly split between stages 0 and 1 and stages 2 to 3, whereas the waitlist participants were a majority breast cancer stage 0 to 1 (83%). Thus, one plausible reason for higher levels of perceived stress in the treatment group at Week 0 may be attributed to more participants with an advanced stage of breast cancer compared to those on the waitlist. While we block randomized participants on breast cancer stage and menopausal status, a recommendation for a future study would be to use perceived stress scores as a randomization variable instead of menopausal status, particularly as most participants were either postmenopausal or on adjuvant endocrine therapy, resulting in most participants in both groups being postmenopausal.

While we did not ask participants to share their chosen mantrams in this study, it would be feasible to assess whether participants choose a traditional mantram versus secular words and phrases in future research. Because MRP is a spiritually-based intervention, traditional mantrams used in MRP research should include those that have been repeated and sanctified over time and have a basis in a spiritual tradition.²⁵ Further, future research may explore whether health outcomes differ when traditional mantrams versus secular words and phrases are used.

Finally, future mantram research may explore whether different health benefits are observed with different types of mantram practice, for example, audible mantram chanting.⁵⁵

In conclusion, a 6-week internet-delivered MRP intervention was feasible and acceptable to women recently treated for breast cancer. The MRP offers a scalable, accessible, and low-cost intervention for breast cancer survivors, especially for those with fewer resources. Our exploratory findings suggest that serum cytokines, particularly IFN-γ and IL-17A, may be appropriate to include as immune measures for future full-scale MRP trials with breast cancer survivors. Further, our pilot data suggest that women with breast cancer may use MRP to support spiritual well-being and reduce perceived stress; however, additional studies are needed.

Supplemental Material

sj-docx-1-ict-10.1177_15347354241290504 – Supplemental material for An Internet Mantram Repetition Program to Promote Well-being in Breast Cancer Survivors: A Feasibility Randomized Controlled Trial

Supplemental material, sj-docx-1-ict-10.1177_15347354241290504 for An Internet Mantram Repetition Program to Promote Well-being in Breast Cancer Survivors: A Feasibility Randomized Controlled Trial by Jennifer M. Hulett, An-Lin Cheng, Jill E. Bormann, Allison B. Anbari, Jane M. Armer, Brooke M. Hartman, B. Ann Bettencourt, LeeAnne B. Sherwin, Edie L. Sperling, Natsayakarn Narkthong, Carol Reinero, Hans Rindt, Kathy Schreiber, Lindsay L. Peterson and Emily Albright in Integrative Cancer Therapies

Supplemental Material

sj-docx-2-ict-10.1177_15347354241290504 – Supplemental material for An Internet Mantram Repetition Program to Promote Well-being in Breast Cancer Survivors: A Feasibility Randomized Controlled Trial

Supplemental material, sj-docx-2-ict-10.1177_15347354241290504 for An Internet Mantram Repetition Program to Promote Well-being in Breast Cancer Survivors: A Feasibility Randomized Controlled Trial by Jennifer M. Hulett, An-Lin Cheng, Jill E. Bormann, Allison B. Anbari, Jane M. Armer, Brooke M. Hartman, B. Ann Bettencourt, LeeAnne B. Sherwin, Edie L. Sperling, Natsayakarn Narkthong, Carol Reinero, Hans Rindt, Kathy Schreiber, Lindsay L. Peterson and Emily Albright in Integrative Cancer Therapies

Supplemental Material

sj-docx-3-ict-10.1177_15347354241290504 – Supplemental material for An Internet Mantram Repetition Program to Promote Well-being in Breast Cancer Survivors: A Feasibility Randomized Controlled Trial

Supplemental material, sj-docx-3-ict-10.1177_15347354241290504 for An Internet Mantram Repetition Program to Promote Well-being in Breast Cancer Survivors: A Feasibility Randomized Controlled Trial by Jennifer M. Hulett, An-Lin Cheng, Jill E. Bormann, Allison B. Anbari, Jane M. Armer, Brooke M. Hartman, B. Ann Bettencourt, LeeAnne B. Sherwin, Edie L. Sperling, Natsayakarn Narkthong, Carol Reinero, Hans Rindt, Kathy Schreiber, Lindsay L. Peterson and Emily Albright in Integrative Cancer Therapies

Footnotes

Author Contributions

Conceptualization: Jill Bormann, Jennifer Hulett, Ann Bettencourt, Jane Armer, An-Lin Cheng, Allison Anbari, LeeAnne Sherwin, Natsayakarn Narkthong, Kathy Schreiber, Emily Albright. Funding acquisition: Jennifer Hulett, Jane Armer. Data curation: Jennifer Hulett, Brooke Hartman, Kathy Schreiber. Formal analysis: Jennifer Hulett, An-Lin Cheng, Edie Sperling, B. Ann Bettencourt, Hans Rindt, Carol Reinero. Investigation: Brooke Hartman, Emily Albright. Methodology: Ann Bettencourt, Jill Bormann, Jane Armer, An-Lin Cheng, Jennifer Hulett, Kathy Schreiber, LeeAnne Sherwin, Hans Rindt, Emily Albright. Roles/Writing – original draft: Jennifer Hulett, An-Lin Cheng, Hans Rindt. Supervision: Jennifer Hulett, An-Lin Cheng, Kathy Schreiber. Writing – review and editing: Allison Anbari, Jane Armer, Ann Bettencourt, Lindsay Peterson, Edie Sperling, Carol Reinero, Emily Albright. All authors read and approved the final manuscript.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported in part, by the University of Missouri Research Council: URC-20-078. The funder was not involved in the study or the preparation of the article.

Ethical Approval

This study was approved by the University of Missouri Institutional Review Board #2033242. All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional Research Board (IRB) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study was approved by the University of Missouri IRB (approval # 2033242) on March 2, 2021. All participants provided written informed consent prior to study enrollment.

Informed Consent

All participants provided informed consent.

ORCID iDs

Jennifer M. Hulett

Lindsay L. Peterson

Supplemental Material

Supplemental material for this article is available online.

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