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Abstract

Awareness of disease diagnosis is one the most basic steps to treatment onset and adherence among patients with cancer (PWC). However, PWC are not accurately informed about their diagnosis and hence, cannot accurately understand treatment options and improve treatment outcomes. This study will evaluate the effects of a culturally-appropriate breaking bad news protocol (BBNP) on PWC in Iran. It will be conducted using a complex mixed methods experimental design and in two quantitative and qualitative phases. In the quantitative phase, a randomized controlled trial will be undertaken to assess the effects of BBNP on depression, anxiety, stress, and life expectancy. Data collection instruments will be the Depression Anxiety Stress Scale and the Adult Hope Scale. In the qualitative phase, a qualitative study will be undertaken using conventional content analysis in order to explore patients’ experiences of breaking bad news. The use of culturally-appropriate and evidence-based breaking bad news guidelines and interventions can improve patient outcomes and protect patient dignity. Trial registry name: Iranian Registry of Clinical Trials (Number: IRCT20240118060721N1).

Keywords

truth disclosure bad news cancer diagnosis protocol evaluation mixed methods study

Introduction

Truth disclosure is a process (Numico et al., 2009) which happens before, during, and after breaking bad news (BBN) to patients and is difficult and unpleasant for healthcare professionals, particularly those who work in oncology care settings (Anestis et al., 2022; Mulugeta et al., 2024). The news of a cancer diagnosis is often unpleasant for the afflicted patients and their families. Bad news (BN) in medical literature is news which negatively affects patients’ attitudes towards life or future (Saqib & Inam Pal, 2021). It can also affect their hope, mental health, and lifestyle (Kumar & Sarkhel, 2023). There are three types of BN in medical area, namely BN about disease diagnosis, BN about poor prognosis, and BN about patient death (Sobczak, 2022). Although physicians and other healthcare professionals are reluctant to break BN, they break 20,000 BN, on average, to their patients during their professional life (Ehsani et al., 2022). Almost 60% of physicians in a study reported that they broke bad news to patients or their families 5–20 times per month (Aein & Delaram, 2014).

The most prevalent concern in the area of BBN to patients with critical conditions is about causing them emotional discomfort and disappointment. Therefore, healthcare professionals and patients’ families have various attitudes about BBN based on their own cultural backgrounds (Yanwei et al., 2017). In family-centered cultures, families tend to protect their patients and hence, avoid BBN to them about cancer diagnosis (Güleç et al., 2017). Healthcare professionals need to individualize BBN based on the unique sociodemographic and cultural characteristics of each patient ((Ehsani et al., 2022; Surbone, 2006). Individualized approaches to BBN help fulfill patients’ needs and preferences, enhance their satisfaction, and reduce BN-related mental burde (Ehsani et al., 2022). Contrarily, poor communication during BBN may lead to negative physical and psychoemotional outcomes such as poor pain management and poor treatment adherence among patients, low job motivation and high stress among healthcare professionals, and legal prosecutions against healthcare professionals (Mulugeta et al., 2024). A study showed that the prevalence of BBN-related distress among physicians was 35.5% before BBN, 45.2% during BBN, and 54.8% after BBN (Anuk et al., 2022)

Using clear guidelines is one of the influential factors on the quality and outcomes of BBN(Anuk et al., 2022; Mahendiran et al., 2023; Warnock et al., 2010). The SPIKES protocol (consisted of Setting, Perception, Invitation, Knowledge, Emotion, and Strategy and Summary) is one of these guidelines (Kumar & Sarkhel, 2023; Mailankody et al., 2022; Warnock et al., 2010) and is used in countries such as the United states, Germany (von Blanckenburg et al., 2020), and Brazil (Alves et al., 2023). A study in Germany revealed that 46.2% of patients with cancer (PWC) were satisfied with BBN through the SPIKES model (Seifart et al., 2014). Educational and clinical challenges in using this protocol led to its modification in 2021 based on patients’ needs and reactions (Kumar & Sarkhel, 2023; Meitar & Karnieli-Miller, 2022). A study recommended the use of the SPIKES protocol in ethnographic studies for providing quality cultural care services (Dean & Willis, 2016). A review study found that none of the reviewed studies had evaluated the effects of the SPIKES protocol on patients and physicians, while its implementation may have positive effects on satisfaction, knowledge, and performance (Mahendiran et al., 2023).

The PENS approach (consisted of Patient preference, Explanation, Next appointment, and Support) is another BBN-related guideline. It is a brief and rapid family-centered guideline for BBN in the sociocultural context of India. Its development revealed the necessity of culturally-appropriate guidelines for BBN in different contexts (Mailankody et al., 2022). Salem and Salem also developed the four-step IGAD guideline (consisting of Interview, Gather, Assess, Decide, Disclosure, and Discuss) for BBN based on the sociocultural and religious context of Muslim countries (Salem & Salem, 2013). However, these guidelines are based mostly on the opinions and experiences of physicians, not patients (Kumar & Sarkhel, 2023). Moreover, there is limited evidence concerning adherence to these guidelines and their effects on patient satisfaction (Seifart et al., 2014).

Abazari et al. also provided a protocol for BBN to PWC and their families in Iran. The six steps of this evidence-based protocol (henceforth referred to as BBNP) are assessment, planning, preparation, disclosure, support, and conclusion. This protocol states that BBN should be performed by a specialized interdisciplinary team consisted of nurses, physicians, and psychologists and BN recipients should be informed about the available support organizations. This protocol also values the BN-related viewpoints of patients’ relatives (Abazari et al., 2017). A study found that the implementation of this protocol can prevent the reduction of life expectancy among patients with gastrointestinal cancers (Abbasi et al., 2024).Previous studies into the effects of BBN-related guidelines mostly used cross-sectional quantitative designs ((Abraha Woldemariam et al., 2021; Alves et al., 2023; Amini et al., 2023; Anuk et al., 2022; Finlayson et al., 2023; Khoshrang et al., 2024; Lounsbury et al., 2023; Mahendiran et al., 2023), which provide limited information about the implementation and evaluation of the guidelines. Studies into the effects of the SPIKES protocol also used quantitative designs to evaluate outcomes such as patients’ preferences, perceptions, and satisfaction (Marschollek et al., 2019; Seifart et al., 2014; von Blanckenburg et al., 2020), or physicians’ attitudes and skills (Khoshrang et al., 2024; Mostafavian & Shaye, 2018). Moreover, qualitative studies in this area did not provide reliable information about the effects of implementing BBN-related guidelines and participants’ perceptions of their implementation (Anestis et al., 2022; Khaki et al., 2024; Matthews et al., 2019; Randall & Wearn, 2005). Besides, most of the BBN-related guidelines were developed based on the sociocultural contexts of western countries and studies on them were undertaken mostly in western countries. Our literature search also showed no study into the effects of BBNP. Therefore, we will undertake a study to evaluate the effects of BBNP on PWC in Iran.

Materials and Methods

This study will be conducted using a complex mixed methods experimental design and in a quantitative phase and a qualitative phase (Figure 1). This design includes the collection, analysis, and integration of quantitative and qualitative data in a clinical trial. In fact, this design adds qualitative data to an intervention and involves participants’ experiences (Creswell & Creswell, 2018). In this study, participants’ experiences of implementing BBNP will be a secondary source of data to support quantitative findings. Pragmatism is the guiding philosophy of the present study. It supports the idea of evidence-based clinical decision-making and is one of its main stimulants (Florczak, 2023).

Figure 1.

The Flow Diagram of the Study

The Quantitative Phase

This phase will consist of a randomized controlled trial in which the statistical analyst will be blind to group allocation. The trial has been registered in the Iranian Registry of Clinical Trials (number: IRCT20240118060721N1).

Participants and Sampling

The intervention will be implemented in the Cancer Institute of Imam Khomeini hospital, Tehran, Iran, which is a leading referral cancer care center in Iran. Study population will comprise PWC with definite pathologically-confirmed diagnosis of cancer who are unaware of their diagnosis. They will be selected through simple random sampling, in which two of the three patient visit days per week will randomly be selected and all eligible patients who will be visited by a surgical oncologist will be recruited. The recruited patients will be divided into a control and an experimental group through block allocation with a block size of four and using the following six blocks: AABB, ABAB, ABBA, BABA, BBAA, and BAAB (A and B stands for the experimental and the control groups, respectively). A research assistant will determine and conceal the allocation sequence. Allocation concealment will help reduce selection bias (Burgers et al., 2012). Inclusion criteria will be age over eighteen years, definite diagnosis of any type of cancer confirmed by pathological studies, unawareness of cancer diagnosis, no self-reported affliction by mental disorders, and ability to verbally communicate in Persian. Exclusion criteria will be incomplete answering to the study instruments and absence from the first preparation session of the study.

The minimum sample size was determined based on the mean score of life expectancy (Ahangarzadeh Rezaei, 2017)and with a confidence level of 0.95, a power of 0.80, and a d of 5. Accordingly, 37 participants per group were determined to be needed for the study (Figure 2). In spite of this, forty participants will be recruited to each group to compensate possible withdrawals.

n = \frac{{(Z_{1 - α / 2} + Z_{1 - β})}^{2} (S_{1}^{2} + S_{2}^{2})}{d^{2}} = \frac{{(1.96 + 0.84)}^{2} ({6.94}^{2} + {7.58}^{2})}{5^{2}} \approx 37

Figure 2.

Sample Size Calculation

Instruments

Study instruments will be the 21-item Depression Anxiety Stress Scale (DASS-21) and the Adult Hope Scale (AHS). Lovibond and Lovibond developed DASS-21 with 21 items in three seven-item domains, namely depression, anxiety, and stress. Items are scored on a 0–3 scale, on which zero stands for “Never” and 3 stands for “Very much”. As DASS-21 is the short form of the original DASS-42, the total scores of the scale domains are multiplied by two and are interpreted as shown in Table 1 (Musarezaie et al., 2015). A study into the psychometric properties of DASS-21 in Iran revealed that the Cronbach’s alpha values of its depression, anxiety, and stress domains were respectively 0.78, 0.79, and 0.77, which confirmed its reliability. Its construct and convergent validity were also confirmed (Sahebi et al., 2005). We will assess the reliability of the scale by calculating its Cronbach’s alpha values.

Table 1.

Interpretation of the Scores of the Dimensions of the 21-Item Depression Anxiety Stress Scale

Categories domains	Normal	Mild	Moderate	Severe	Extremely severe
Depression	0–9	100–13	140–20	210–27	≥28
Anxiety	00–7	80–9	100–14	150–19	≥20
Stress	00–14	150–18	190–25	260–33	≥34

AHS, developed by Snyder et al. (Snyder et al., 1991), has four items on agency thinking (i.e., items 2, 9, 10, and 12), four items on pathway thinking (i.e., items 1, 4, 7, and 8), and four filler items (i.e., items 3, 5, 6, and 11). The possible total score of the scale is 8–64 and higher scores indicate greater life expectancy. A study in Iran found that the Cronbach’s alpha values of the scale were 0.74–0.84 and its test-retest correlation coefficient was 0.8 (Khaleghkhah et al., 2019). Both instruments will be completed before, one month, and three months after the intervention.

Intervention

The intervention of this study will be BBN based on BBNP and will be implemented by an interdisciplinary team consisted of a surgical oncologist, an oncology nurse, and a clinical psychologist as the main team members as well as a nutrition specialist, a cleric, and a psychiatrist as support team members. The job specifications of each team member before, during, and after BBN have been determined in BBNP. The target group of the intervention will be adults with definite diagnosis of any cancer type established based on medical studies. Another team consisted of experts in nursing, research, and biostatistics from Tarbiat Modares University, Tehran, Iran, will supervise the intervention. The intervention will independently be implemented for each participant in the six main steps of BBNP, namely assessment, planning, preparation, disclosure, support, and conclusion.

Assessment

In this step, the patient and then his/her closest family member will independently and privately be assessed for their sociodemographic characteristics, desire to receive information about diagnosis, and family’s agreement for informing the patient about diagnosis. Team members will independently introduce themselves to the patient and the family member and explain the goals of the assessment session. The assessment session will pave the way for further communication with the patient and the family member and assessment data will determine the best method for BBN.

Planning

Based on the assessment data, three main states may occur which are explained in what follows.

(1) The patient likes to receive information about diagnosis and the family agrees with informing the patient about diagnosis. In this state, diagnosis-related information will be provided to both of them in a joint session based on the principles of BBN.

(2) The patient likes to receive information about diagnosis but the family disagrees with it. In this state, we will hold a private session with the family members to satisfy them through explaining the benefits of truth-telling.

(3) The patient doesn’t like to receive any information about diagnosis but prefers informing the family. In this state, we will provide information about diagnosis to the family and ensure the patient that he/she will receive information about diagnosis at will.

Preparation

Family Preparation

If state 2 occurs, a family preparation session will be held to assess family’s reason for disagreement with BBN to the patient and to reach an agreement about BBN to the patient. Some family members may be agitated and confused and need a complex preparation process. If so, the psychologist member of the team will also be involved in family preparation.

Setting Preparation

A clean, comfortable, and private environment will be considered for BBN. Any intervening factor such as telephone ringing will be eliminated. Moreover, a same-gender nurse will be invited to attend the BBN session when the patient has breast, prostate, or urogenital cancer.

Patient Preparation

The nurse member of the BBN team will determine the time and place for the BBN session and inform other team members, the patient, and family members about the session. Before the BBN session, the team members will hold a joint session, without patient and family attendance, to exchange their information. In the BBN session, the surgical oncologist will introduce himself and other team members, explain the session goals, and prepare the patient and the family for BBN through asking some questions. He will avoid BBN and postpone it to another session if the patient, express excessive optimism about his/her disease, or tend to deny affliction by any serious disease.

Disclosure

In this step, the oncologist will inform the patient and the family about the diagnosis using a clear and simple language and a compassionate, empathetic, respectful, and humanistic approach. He will provide prognosis-related information only if requested by the patient or the family. If the patient or the family wants to know about the time of death for better decision-making, the oncologist will provide a time range which includes the average life expectancy time, for example, “Several weeks to several months”.

Support and Education

All BBN team members, particularly the oncologist who provides diagnosis-related information, will have active involvement in this step. After the disclosure step, the oncologist, nurse, and psychologist will provide the patient and the family with emotional support, attempt to find the reasons for their concerns, and help and encourage them express their feelings and concerns. If assessment data show that the patient has mental problems, use antipsychotic medications, or is at risk for suicide, he/she will be referred to the psychiatrist team member.

Conclusion

At the end of the BBN session, the following actions will be taken:

(1) All the session events will be reviewed and the treatment and care plans will be discussed.

(2) The patient and the family will be ensured of our support throughout the course of treatment.

(3) The patient and the family will be asked to raise their questions.

(4) A summary of the necessary information about the support associations for PWC will be provided.

(5) Before the session comes to end, patient safety issues, such as the ability to drive to home or the risk of suicide, will be assessed.

Participants in the control group will be informed about their cancer diagnosis using the routine BBN practice which includes no preparation and no use of any specific guideline. They will also be referred to a surgical oncologist or a radiotherapist to receive the routine treatments.

Data Analysis

Descriptive measures including range, mean, and standard deviation will be used for data summarization. Normality will be tested via the Kolmogorov-Smirnov test. Moreover, the Chi-square, Fisher’s exact, and independent-sample t tests will be conducted for between-group comparisons. The repeated measures analysis of variance will also be conducted for within-group comparisons respecting the variations of the mean scores of depression, anxiety, stress, and life expectancy across the three measurement time points. Data analysis will be performed using the SPSS software (v. 26.0) and at a significance level of less than 0.05. The results will be reported using the Consolidated Standards of Reporting Trials (CONSORT) criteria.

The Qualitative Phase

In this phase, a qualitative study will be undertaken using conventional content analysis in order to explore patients’ experiences of BBN. Conventional content analysis helps obtain direct and manifest information from the data without imposing any predetermined theory or framework (Aein & Delaram, 2014).

Participants and Data Collection

Study population will be the forty PWC in the intervention group of the quantitative phase. Participants will purposefully be selected and data will be gathered via in-depth semi-structured interviews with open-ended questions and an interview guide (Table 2). As the main goal of the qualitative phase is to assess the effects of the intervention on depression, anxiety, stress, and life expectancy, interview questions will also be about these outcomes. Interviews will be conducted in a quiet and private environment and based on participants’ time and place preferences and will be carried on until no new data will be obtained from them.

Table 2.

Interview Questions

Main questions	Probing questions
May you please explain about your feelings after knowing your diagnosis?	What do you mean by this?
May you please talk about the program you participated in before hearing about your diagnosis?	May you explain more?
May you please describe your feelings about our approach to inform you about your diagnosis?	May you please provide an example to help me better understand this?
Can you explain about your life after knowing your diagnosis?
Will you ever recommend other patients to participate in programs like our program? Why?
What recommendations do you have to improve our program?

Data Analysis

Graneheim and Lundman’s five step conventional content analysis will be used for data analysis. The five steps of this analysis are immediate transcription of the interviews, transcript perusal to grasp it main ideas, determination and coding of the meaning units, categorization of the codes into larger categories, and determination of the main themes (Graneheim & Lundman, 2004). Data analysis will be performed concurrently with data collection and categories will be labeled using abstract labels. The OpenCode software will be used for data management.

Rigor

The criteria developed by Guba and Lincoln will be used for rigor maintenance. These criteria are credibility, transferability, dependability, and confirmability (Guba & Lincoln, 1994).

Ethical Considerations

The Ethics Committee of Tarbiat Modares University, Tehran, Iran, has approved the study (code: IR.MODARES.REC.1402.249). The study will be undertaken based on the Declaration of Helsinki.

Discussion

To the best of our knowledge, none of the previous studies has yet evaluated the effects of using BBNP on patient outcomes. BBNP is a holistic and supportive nurse-oriented protocol. Holistic nursing effectively reduces the negative feelings of PWS, improves their motivation for continuing their treatments, and increases their self-confidence (Wen et al., 2021).

A study found that the implementation of need-based culturally-appropriate interventions for BBN can minimize the negative effects of cancer diagnosis awareness and facilitate care provision to PWC. BBN through an interdisciplinary team supports the establishment of a strong interpersonal relationship which considers patients and caregivers as multidimensional human beings (Guerdoux et al., 2022). Protocol-based care is a process which facilitates the provision of integrated patient care and development of nurses’ professional roles because it supports independent nursing practice and integrated care provision (Rycroft-Malone et al., 2008). Nurses play significant roles before, during, and after BBN. For example, they prepare patients, families, and setting and determine patients’ and families’ potential reactions to BN before BBN, determine their emotional needs during BBN, and help them make the best decisions for treatment and care after BBN (Wahyuni et al., 2023). They also play educational, counseling, facilitator, and supportive roles in BBN (Khaki et al., 2024).

BBN can be challenging for healthcare providers due to their personal beliefs, sense of insufficiency, or self-blame and hence, it should be performed in a participatory process (Bosshard et al., 2023). Therefore, we designed the present study with a participatory approach and an interdisciplinary team. A study into the BN-related experiences, reactions, and preferences of PWC in Germany found that they needed comprehensive support by a specialized team from the time of cancer diagnosis in order to minimize the intensity of reactions such as shock, aggression, denial, and depression, improve their mental health, and fulfill their informational needs (Krieger et al., 2023). Moreover, the effective management of relational situations (such as the BBN situation) in oncology care wards considerably improves patients’ coping and treatment adherence and reduces healthcare providers’ disappointment and fatigue (Naderi Nabi et al., 2022).

The application of BBNP in clinical settings facilitates BBN to PWC through an interdisciplinary approach and provides a holistic view towards patients and their families. If this study shows the effectiveness of BBNP, its findings can be used to develop strategies for cost-effective patient-centered care provision.

Footnotes

Acknowledgements

This article is the result of a PHD’s thesis in nursing at Tarbiat Modares University, Tehran, Iran. We extend our gratitude to all instructors of the Nursing Department of this university, as well as the authorities, nursing managers, and patients and nurses of Imam Khomeini Hospital.

ORCID iDs

Nilofar Oladrostam

Mitra Khoobi

Eesa Mohammadi

Ethical Approval

The Ethics Committee of Tarbiat Modares University, Tehran, Iran, has approved the study (code: IR.MODARES.REC.1402.249). The study will be undertaken based on the Declaration of Helsinki.

Consent to Participate

Informed consent to participate was written.

Author Contributions

All authors (NO, MKH, EM, IH) contributed equally to this article in study conception and design, data collection, data analysis and interpretation, and drafting of the article. Each author participated sufficiently in the work to take public responsibility for its content.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

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

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Implementation and Evaluation of a Culturally-Appropriate Protocol for Breaking Bad News to Patients With Cancer in Iran: Study Protocol for a Complex Mixed Methods Experimental Study

Abstract

Keywords

Introduction

Materials and Methods

The Quantitative Phase

Participants and Sampling

Instruments

Intervention

Assessment

Planning

Preparation

Family Preparation

Setting Preparation

Patient Preparation

Disclosure

Support and Education

Conclusion

Data Analysis

The Qualitative Phase

Participants and Data Collection

Data Analysis

Rigor

Ethical Considerations

Discussion

Footnotes

Acknowledgements

ORCID iDs

Ethical Approval

Consent to Participate

Author Contributions

Funding

Declaration of Conflicting Interests

References