A pelvic health eRehabilitation program to address urogenital impairments after breast and gynecologic cancer: A proof-of-concept study protocol

Abstract

Background

Incontinence and vulvar pain are common urogenital dysfunctions after breast and gynecological cancers (BGCs). Recent evidence suggests that pelvic health physiotherapy can improve these dysfunctions and enhance quality of survivorship, but several barriers limit access to such care. Virtual programs are proposed as a strategy to improve access.

Aim

The main aim of this proof-of-concept study is to evaluate the feasibility and acceptability of the newly designed Pelvic Health eRehabilitation Program in people treated for BGCs. The study also aims to explore the preliminary effectiveness of the Program in reducing urogenital impairments.

Methods

This study uses a proof-of-concept, interventional prospective cohort design. Twenty individuals with BGCs presenting with urogenital dysfunction (score ≥2 on the Pelvic Floor Bother Questionnaire) will be recruited in the Canadian provinces of Quebec and Alberta. The Program includes twelve weekly small-group online educational sessions with a pelvic health physiotherapist, five individual exercise prescription sessions, and access to a variety of online resources. The following standardized patient-reported outcome measures will be used: the International Consultation on Incontinence modular questionnaires for bladder and bowel symptoms, the Vulvar Pain Assessment Questionnaire, and the Female Sexual Function Index. Evaluations will be conducted before (E1), halfway through (E2), and immediately after (E3) the intervention.

Conclusion

Findings from this study will inform the feasibility, acceptability, and preliminary effectiveness of the Program for individuals experiencing urogenital dysfunction following BGCs treatment, supporting future development of a randomized controlled trial. This virtual Program holds promise to improve equity in access to pelvic health services.

Background

Breast and gynecological cancers (BGCs) account for just under 40% of all new cancer diagnoses in individuals of the female sex worldwide.^1,2 People treated for BGCs commonly report a variety of urogenital dysfunctions after cancer treatments, such as urinary incontinence, vulvar pain and dyspareunia.^3,4 For people treated for gynecological cancer, the prevalence of urogenital dysfunctions is high: 40%‒83% report urinary incontinence,^3–7 40%‒100% sexual dysfunctions,^8–10 and 18%‒70% bowel disorders, depending on the studies.^7,8 Among people treated for breast cancer, between 41% and 71% of tamoxifen users (hormone therapy to treat breast cancer) report experiencing urinary incontinence,^11–13 while over 40% report dyspareunia. ¹⁴ Different cancer treatments can contribute to the development of urogenital impairments in these populations, including pelvic surgeries, radiation therapy, hormonal therapy and chemotherapy. Given the high incidence of BGCs, ¹⁵ the number of people living with urogenital impairments after cancer treatment is therefore considerable. This is of particular concern, as these impairments are known to reduce the participation of individuals treated for cancer in daily activities, physical activity, sexual function, and health-related quality of life.^3,8,16,17

Physiotherapists with expertise in pelvic health perform interventions such as education on bladder control, dilation therapy and pelvic floor muscle training to address urogenital impairments.^18,19 While not all apply uniformly, some of these interventions are recommended as first-line treatments for specific conditions, such as urinary incontinence and vulvodynia, in individuals without a history of cancer.^20–22 In people without cancer experiencing dyspareunia, there is Level-II evidence supporting the benefit of pelvic health interventions over pharmaceutical treatment in reducing pain and in improving sexual function. ²² For individuals experiencing fecal incontinence, there is Level-II evidence supporting pelvic floor muscle training for symptom improvement, particularly when delivered by an experienced therapist. ²³ For individuals treated for BGCs, evidence is beginning to emerge to support pelvic health interventions.^18,19 A recent systematic review (2020) reported benefits from pelvic floor muscle training and dilation therapy on sexual function and quality of life in individuals treated for gynecological cancers. ²⁴ More recently published work further supports pelvic health physiotherapy in reducing dyspareunia and in improving urinary incontinence among individuals treated for gynecological cancers.^18,25 Emerging data among people treated for breast cancer also suggest potential benefits of conservative approaches in physical therapy to reduce symptoms related to urinary incontinence. ²⁶ Together, these recent findings highlight the potential of pelvic health interventions to address multiple late effects and improve quality of life in individuals treated for BGCs.

Despite this growing evidence supporting the effectiveness of physiotherapy interventions, access to such interventions is often limited for people during or after cancer treatments. Access to care may be limited by barriers such as the absence of cancer rehabilitation services in cancer centers, financial costs, having to travel to obtain services, or the immune-compromised state of health of people with cancer who are required to limit their face-to-face activities. ²⁷ In the context of the COVID-19 pandemic, a mixed-method study was conducted to identify the needs, facilitators and barriers to pelvic health physiotherapy interventions after gynecologic cancer treatments. ²⁷ Based on these results, virtual pelvic health interventions were identified as one strategy to improve access. ²⁷ Indeed, virtual interventions have the potential to facilitate access to pelvic health resources by reducing the financial costs and embarrassment associated with in-person visits, and by mitigating literacy and language barriers when compared to booklet or brochure-style resources. ²⁷ Despite the potential of virtual pelvic health interventions to enhance access, few studies have explored their effects on urogenital symptoms in people treated for BGCs; however, their results are promising.^18,26,28 To address this gap, the Pelvic Health eRehabilitation Program (PHRP) has been developed as a virtual intervention specifically tailored to the needs of individuals treated for cancer. The program adapts exercises, mobilization strategies, and educational content to account for cancer- and treatment-related changes, including radiation-induced fibrosis of muscle tissue; fibrosis-related urinary retention due to involvement of the detrusor muscle, bladder neck, or urethra; vaginal stenosis and shortening following hysterectomy and radiation; and vaginal dryness associated with endocrine therapy and early menopause.^29–32 As an initial step, we aim to conduct a proof-of-concept study examining the feasibility, acceptability and preliminary effects of this novel PHRP in individuals experiencing urogenital dysfunction following BGCs treatment. This study will serve as the foundation for a future randomized controlled trial.

Methods

Design and flow of the study

For this study, a one-arm proof-of-concept design involving a 12-week intervention was selected to lay the groundwork for a future multicenter RCT. This study is designed in accordance with Eldridge and colleagues ³³ conceptual framework for feasibility studies to assess the suitability and practicality of the proposed intervention, as well as Elliot et al. ³⁴ recommendations for proof-of-concept research. Pilot and proof-of-concept studies commonly enroll between 12 and 30 participants for pragmatic reasons, given that formal power calculations are unnecessary at this stage.^35,36 Accordingly, the sample size of N = 20 participants planned for this study aligns with methodological guidelines for early-phase feasibility research. This study also follows the Strategy for Patient-Oriented Research (SPOR), ³⁷ and the Chronic advanced cancer rehabilitation conceptual framework for engagement of individuals with lived experience, ³⁸ designed to incorporate interest-holder views at every stage of the research process. We have recruited two interest-holder partners (1 patient partner, 1 clinician partner) to work together with the research team. As illustrated in Figure 1, participation in the study involves a baseline evaluation (E1) before the start of PHRP, a second evaluation halfway into the intervention (at 6 weeks; E2), and a final evaluation at the end of the intervention (E3).

Figure 1.

Flow of the study.

Study setting

This study is multicentric, as it will be conducted in two locations (Québec and Edmonton, Canada). Interventions will be available in two languages: French and English. In Québec, the Centre interdisciplinaire de recherche en réadaptation et intégration sociale will serve as the primary site for study coordination, including the delivery of interventions in French. In Edmonton, the Cross Cancer Institute, a tertiary cancer center, will serve as the recruitment site, with English-language interventions delivered through the Cancer Rehabilitation Clinic.

Participants and selection criteria

Eligible participants will comply with the following selection criteria: (1) be >18 years of age; (2) have received a diagnosis of breast or gynecological (endometrial, cervical, ovarian, vulvar or vaginal) cancer (International Federation of Gynecology and Obstetrics Stages I‒IV); (3) be currently receiving any form of active or maintenance cancer treatment (regardless of type or intensity), or have completed cancer treatment (surgery, radiation therapy, and/or chemotherapy) within the past 4 years; (4) have a urogenital dysfunction, as screened by a score of ≥2 on the Pelvic Floor Bother Questionnaire; and (5) be able to provide informed written electronic consent in English or French. Exclusion criteria are: (1) individuals who do not have regular access to internet, to a smart device or a computer, at home.

Recruitment procedures

Participants will be recruited using a combination of convenience and snowball sampling strategies. Convenience sampling will involve identifying eligible individuals through oncology follow-up clinics and previous research patient databases from both participating sites. Snowball sampling will be used to broaden recruitment by sharing study information through social media campaigns. Invitations will also be distributed through patient support groups on social media. Interested individuals will be required to initiate contact with the research team if they are interested in taking part in the study either by telephone or through a secure Research Electronic Data Capture (REDCap) form. ³⁹ The study coordinator will confirm their eligibility during a telephone call; informed written electronic consent will be obtained from each participant before the start of their participation.

Intervention

The PHRP will be 12 weeks in duration, in accordance with the recommended time required for training involving the pelvic floor muscles. ⁴⁰ The PHRP has a unique three-part structure: (1) live, small-group, weekly online exercise and education sessions; (2) personalized one-on-one follow-ups; and (3) an online platform providing access to additional content and summary resources at any time. The weekly small group sessions will take place via the secure Zoom videoconferencing software with three to five participants and will be conducted in either French or English. During small group sessions, participants will be able to choose whether or not to turn on their camera, change their display name, and speak, depending on their comfort level and privacy preferences. The sessions will be led by a registered physiotherapist with expertise in pelvic health. Topics covered include: (1) introduction to pelvic floor muscle training; (2) vaginal moisturizers and lubricants; (3) hydration and diet; (4) optimal voiding and bowel emptying techniques; (5) introduction to vulvo-vaginal mobilization techniques and dilation therapy; (6) progressing pelvic floor muscle training; (7) voiding frequency; (8) urinary urgency control; (9) pain management; (10) progression of vulvo-vaginal mobilization techniques; (11) progression of pelvic floor muscle training; and (12) strategies for long-term adherence. The content was selected according to the investigators’ clinical experience, evidence, Interest-holders’ input and the results from our prior study on the needs associated with pelvic health among gynecological cancer survivors. ²⁷ Several video animations and graphics were developed to provide pelvic health education that reflects the specific presentation and symptom progression of urogenital dysfunction following BGCs (see an example illustrated with Figure 2). During the sessions, a progressive 12-week pelvic floor muscle exercise program will also be taught and tailored to each participant's needs. The exercise program will initially focus on improving participants’ ability to perform a voluntary contraction of the pelvic floor muscles, as well as a full post-contraction relaxation. ⁴¹ To do so, participants will be encouraged to self-validate the contraction and relaxation using visual (mirror) or tactile feedback (e.g., hand on vulva, sitting on a rolled-up towel). Over time, and tailored to each participant's needs, the exercises will progressively target improvements in strength, endurance, and coordination. ⁴² For some participants, the challenge will be to improve their post-contraction relaxation after exercises that require stronger, longer, or faster contractions. If needed, exercises will be complemented with breathing and pelvic floor relaxation techniques, such as resting yoga poses (child's pose, frog pose) and vulvo-vaginal self-mobilization techniques.

Figure 2.

Anatomical diagrams for before and after hysterectomy (on the left), and hemi-vulvectomy (on the right).

In addition to the pelvic floor muscle training program, the intervention will also involve a minimum of five individual sessions between the pelvic health physiotherapist and each participant to provide personalized exercise prescription. These sessions will include subjective assessment of symptoms, routine screening for adverse effects and potential complications such as infection, bleeding, or other symptoms requiring medical attention, as well as evaluation of perceived progress or difficulties with the exercises. Based on this subjective information, exercises may be modified, and personalized counseling and education will be provided regarding the applicability of other program components to each participant's context. These meetings are expected to last 15 min. Moreover, resources supporting the content presented in the sessions will be accessible on the online HEAL-ME platform (see Figure 3). This will include video summaries of key topics, anatomical illustrations tailored to individuals undergoing cancer treatment, and resources to support proper exercise execution and behavior change related to adherence to prescribed pelvic floor muscle exercises. These tools have been developed with particular attention to diversity and inclusion, opting for illustrations with diverse body features, with a glossary of words and terms used with definitions in simple lay language, as well as allowing for the addition of subtitles for the videos. At last, standardized training, bilingual intervention materials, uniform data collection tools, regular fidelity monitoring by the trainer, and therapist self-checklists will be used to ensure consistent intervention delivery across sites and languages.

Figure 3.

Online resources on the HEAL-ME platform including weekly goal, educational videos, anatomical diagrams and weekly exercise program.

Data collection

Considering that the PHRP aims to facilitate access to pelvic health interventions, the acceptability outcomes selected for this study are based on Lévesque, Harris and Russell's conceptual model of access to healthcare, in which access is presented as an opportunity to seek and receive appropriate healthcare for our need. ³³ Several dimensions are identified as influencing access to care, including identification of healthcare needs and care, prior access to pelvic healthcare, acceptability of care, availability of care, prior barriers to meeting pelvic health needs, affordability and appropriateness of healthcare.^43–45 In addition to sociodemographic data, several measures will be collected to specifically assess the feasibility (adherence rate, attrition rate) and acceptability of the new PHRP, including satisfaction with ease of access to intervention, relevance of content, perceived effectiveness of the intervention using the Patient Global Impression of Change scale, perceived burden, appropriateness of intervention and sense of safety, and usability using the System Usability Scale questionnaire.^46,47 Preliminary effectiveness of the PHRP will be evaluated using standardized patient-reported outcome measures (PROMs). These questionnaires will be administered at E1, E2 and E3 in either English or French: International Consultation on Incontinence Questionnaire (ICIQ)^48,49 modular questionnaire for urinary and bowel symptoms, the Vulvar Pain Assessment Questionnaire ⁵⁰ to assess vulvar pain intensity, associated unpleasantness and distress, the Female Sexual Function Index^51,52 to assess six domains of sexual functioning, and the Perceived Self-Efficacy scale, ⁵³ modified from the self-efficacy for chronic disease management questionnaire, to determine a person's perceived overall ability to cope with symptoms in various challenging or stressful situations. All questionnaires and PROMs will be auto-administered online by participants from automatic invitations sent out through the REDCap secure system, used for data collection and management.

Patient and public involvement

This study follows the SPOR by involving interest-holders within the research team to help adapt research methods and ensure that the representation and dissemination of results are fair and effective for patients. As such, one Person With Lived or Living Experience (PWLLE) of gynecological cancer joined the research team to share and contribute her experiential knowledge to each of the research activities of this study, including the design. The PWLLE was invited to contribute to her preferred level of engagement, ⁵⁴ and has been involved in the conceptualization of this study, in editing the proposal and the study protocol, according to her experience and point of view. The PWLLE also contributed to the development of the program, for instance by reviewing study materials on the web platform, ensuring their inclusivity, relevance, exhaustiveness and comprehensibility. The PWLLE is invited to participate further in upcoming research activities such as the interpretation of the data analyses and dissemination of results.

Analysis plan

Descriptive statistics will be conducted to describe personal characteristics using median and range, while frequency analyses will be calculated for feasibility outcomes (i.e., adherence and attrition rates). In line with recommendations for pilot studies,^33,55,56 descriptive statistics for variables resulting from surveys and PROMs will be calculated at E1, E2 and E3 to summarize data. Normality of distributions will be examined using Shapiro-Wilk tests. Exploratory within-participant treatment effects (time course, preliminary efficacy) will be compared at E2 (E2 vs. E1) and E3 (E3 vs. E1) using Wilcoxon signed-rank tests on questionnaires’ total and subscale scores for non-parametric data. Given the proof-of-concept design and primary focus on feasibility, no formal correction for multiple comparisons are planned, particularly as independence among outcome measures cannot be assumed due to conceptual overlap; secondary and exploratory findings will be interpreted cautiously and considered hypothesis-generating.

Discussion

The results of this study will contribute to a better understanding of the acceptability and feasibility of a virtual PHRP for individuals treated for BGCs. This is particularly important given the high prevalence of pelvic health needs in this population and the limited access to appropriate care. Digital health tools such as the PHRP offer a promising strategy to reduce this disparity by addressing barriers like geographic distance and financial constraints. However, for such tools to effectively improve access, their design and delivery must first be deemed acceptable and feasible by users. ⁵⁷ Feasibility includes on-the-ground testing of the various methodological aspects of a study to validate whether these aspects should be retained or modified in a larger-scale study. ⁵⁸ Although the primary objective of this study is to assess the feasibility of the PHRP, a secondary objective is to explore its preliminary effectiveness. We acknowledge that the small sample size limits the interpretation of these findings, as it is primarily suited for feasibility assessment. Nonetheless, we believe that these preliminary data will guide decision-making regarding the design and planning of future research involving the PHRP. Another expected limitation of this study is the absence of long-term follow-up, as sustainability of effects was not assessed at this proof-of-concept stage. However, follow-up assessments are planned in future trials should the results support progression to a larger RCT. Lastly, although the intervention was designed to reflect real-world clinical practice by allowing individualized exercise prescriptions based on standardized assessment questions, this approach may limit exact replication, comparability in future larger trials, and standardization of exercise prescriptions.

Conclusion

This study seeks to improve access to specialized pelvic health care for people diagnosed with BGCs who also have urogenital dysfunction, regardless of factors such as income, health status, or place of residence. Results will generate evidence to inform the feasibility, acceptability, and preliminary effectiveness of the program, laying the groundwork for future efforts to enhance survivorship care after BGC treatment.