Effects of a theory-driven, disclosure-based family support programme on fear of cancer recurrence for couples coping with breast cancer: protocol for a multi-centre randomised controlled trial

Abstract

Background

Breast cancer incidence in women is increasing, although the survival rate remains high. It is regarded as a ‘couple disease’, with male partners typically the key family member within the household, providing basic care after discharge. Fear of cancer recurrence (FCR) represents a leading unmet need for women with breast cancer and their partners, and evidence has indicated that FCR levels are correlated within couples. Although numerous interventions have focused on women’s FCR, relatively few have been designed specifically for partners. Given the interdependent nature of FCR between women and their partners, addressing partners’ FCR or adopting a dyadic approach may contribute to reducing women’s FCR. Consequently, interventions that actively engage both members of the couple are needed.

Method

This is a two-arm, parallel-group randomised controlled trial involving 90 couples coping with breast cancer, who will be randomly allocated to receive either the 6-week family support programme delivered via WeChat (n = 45) or 6 weeks of follow-up WeChat calls (n = 45). Outcomes including FCR, social constraints, intrusive thoughts, avoidance, anxiety, and stigma in women with breast cancer and their partners will be assessed at baseline, 6-weeks post-intervention, and 12-week follow-up assessment. Adherence to disclosure within couples and adherence to physical activity and healthy dietary practice in women will be recorded. Independent t-tests and chi-square tests examine the comparability of groups in terms of demographics and disease-related information produced by randomisation. Generalised linear mixed model (GLMM) will be used to evaluate the effectiveness of the family support programme.

Discussion

This study will provide rigorous evidence on the effectiveness of the family support programme on FCR for couples coping with breast cancer. Couple-based supportive-oncology programmes, such as the family support programme, that provide educational content on breast cancer-related knowledge, physical activity, healthy diet, psychosocial factors related to breast cancer recurrence, and disclosure in a supportive environment, may be a viable option to reduce FCR, social constraints, and foster cognitive processing for couples coping with breast cancer. This work will address the research gap that limited evidence for interventions that alleviate FCR in women with breast cancer.

Trial registration

ChiCTR2400087252, registered on 23 July 2024, https://www.chictr.org.cn/showproj.html?proj=230362

Introduction

Breast cancer is now the most frequently diagnosed cancer in women worldwide. Fear of cancer recurrence (FCR) is among the top unmet needs for both women with breast cancer and their caregivers [1, 2]. FCR refers to the fear, worry, or concern that cancer may return or progress [3]. Clinical FCR is characterised by persistent preoccupation with recurrence or worry and heightened vigilance to bodily symptoms lasting for at least 3 months [4]. When triggered and not adequately addressed, FCR tends to remain stable across the disease trajectory over long periods [5]. The pooled prevalence of FCR is 50% among women with breast cancer and 45% among caregivers [1, 2]. Given the interplay of FCRs in women and their caregivers, many studies have suggested alleviating women’s FCR by including caregivers or by addressing caregivers’ FCR [6–8]. The family is a social system [9] and represents the primary social unit for individuals [10]. Breast cancer is often described as a ‘couple disease’ and partners play a prominent role within the household context by providing daily care and emotional support to the women [10]. However, the substantial demands of caregiving frequently lead to caregiver fatigue and can hinder the ability of partners to sustain optimal physical and emotional intimacy with the women [11].

A systematic review and meta-analysis explored the effectiveness of family involvement interventions for managing FCR among women with breast cancer and their caregivers, which included seven RCTs published between 2005 and 2023, with a total of 610 women-caregiver dyads [12]. The meta-analytic finding showed that studies using integrating disclosure with education or counselling tailored to participants’ specific needs can produce substantial short-term reductions in FCR among women with breast cancer. However, evidence for effectiveness in caregivers remains limited, with only one study showing a non-significant benefit. Disclosure is a communication process in which an individual reveals personal information to another person. The information can be descriptive or evaluative and can include thoughts, feelings, aspirations, goals, failures, successes, fears, and dreams, as well as one’s likes, dislikes, and favourites [13]. Literature has consistently reported that people have barriers in expressing their emotions, especially when they are facing social constraints [8, 14]. Social constraints are negative social responses that can lead to avoidance of thinking or talking about cancer. They may inhibit cognitive processing and exacerbate emotional distress [8]. Studies have shown that both women and their partners have social constraints and find it difficult to express their true emotions and feelings [8, 15]. They may conceal worries, deny concerns, or defer to their partners to avoid disagreement and to minimise distress and burden [16]. Family involvement interventions are particularly well suited to reduce inhibited disclosure of disease-related concerns because they can more effectively address social constraints on disclosure, protective buffering, and the respective roles of both partners in maintaining these patterns. By fostering a more supportive family environment, women with breast cancer and their partners are better able to share their concerns, fears, and worries with one another, which in turn may reduce FCR in both parties.

Guided by the integrative model of FCR proposed by Simonelli et al. [17], a theory-driven disclosure-based family support programme was developed and pilot-tested for its feasibility in 15 couples coping with breast cancer [18]. The model postulates that FCR is aroused by some triggers or cues through a main cognitive processing and appraisal procedure, with two sets of factors: environmental-related factors (e.g. social constraints, social constraints on disclosure, and stigma) and personal-related factors (e.g. physical symptoms, treatment side effects, coping history, financial issue, and medical follow-up) affecting the main cognitive processing and appraisal procedure. To date, interventions using disclosure to alleviate FCR in women with breast cancer and their partners have rarely incorporated modifiable personal factors (e.g. management of side effects/symptoms, coping history). Literature has documented that healthy lifestyles, such as physical activity and a healthy diet, can reduce cancer recurrence risk [19, 20], and that physical activity can mitigate side effects and symptoms from cancer treatment [21]. In addition, psychosocial stressors, including adverse life events, depression or anxiety, and limited social support, have been linked to immunosuppression and pro-inflammatory signalling, providing biologically plausible pathways to metastasis and recurrence [22]. Education that equips women and partners with coping strategies to address these psychosocial factors may therefore help to reduce FCR. This study proposes to adopt a family support programme, including providing education on physical activity, a healthy diet, psychosocial factors related to breast cancer recurrence, plus disclosure between couples, to minimise their FCR level through the reduction in their perception of cancer recurrence, and at the same time to prepare them with some relevant topics for disclosure discussion. Therefore, in this study, we will test the effects of a theory-driven, disclosure-based family support programme, which has three components: (1) education on breast cancer and a healthy lifestyle (physical activity and healthy diet) to increase their sense of cancer control by managing treatment side effects and reducing cancer recurrence, delivered to women with the support of their partners; (2) disclosure of feelings and thoughts between the couples to reduce social constraints; and (3) additional education on psychosocial factors related to cancer recurrence to increase their sense of cancer control. Figure 1 maps programme components onto Simonelli’s integrative model of FCR. We hypothesise that a theory-driven, disclosure-based family support programme is effective in reducing FCR in both women with breast cancer and their partners.

Fig. 1.

Conceptual framework of the intervention based on Simonelli’s integrative model of FCR [17]

Method

Study design and setting

A two-arm, parallel-group randomised controlled trial (RCT) with a 1:1 allocation ratio and post-intervention at 6 weeks and follow-up at 12 weeks after recruitment. The study will recruit subjects from eight wards in two hospitals serving breast cancer patients in China, each with over 1000 beds, serving patients from both rural and urban areas. The first hospital will be the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, in Hunan Province, comprising five wards recruiting women with breast cancer: two breast surgical wards, one oncoplastic surgery ward, one breast medical ward, and one thoracic radiotherapy ward. Collectively, these wards provide care to approximately 2500 breast cancer patients annually. The second hospital will be the Affiliated Suzhou Hospital of Nanjing Medical University in Jiangsu Province, which comprises two surgical wards for breast cancer and one oncology ward across two locations, providing care to approximately 600 breast cancer patients annually. The flowchart of the study is shown in Fig. 2.

Fig. 2.

Flowchart of the study

Participants

Participants of the study will be couples of women with breast cancer and their male partners.

Couples will be included if:

1. The dyad (i.e. couples that are married, engaged, or otherwise romantically paired and with different genders) involves women diagnosed with breast cancer according to pathological examination, in stage I–IV, either undergoing treatment or having completed treatment, and their male partners who are identified by the women as the caregivers.

2. Both members in the dyad aged 18 years or above.

3. At least one member in the dyad has a clinically significant FCR level (i.e. the score in the fear of progression scale (FoP-Q-SF) ≥34).

4. Both members in the dyad have WeChat for communication.

Couples will be excluded if they:

1. At least one member of the dyad has a physical impairment such as blindness or paralysis.

2. At least one member of the dyad is unable to speak and understand Mandarin as the intervention will be given in Mandarin. Participants who are unable to speak and understand the language may face the difficulty of continuing all the sessions.

3. At least one member of the dyad has a history of mental illness.

4. The original cancer diagnosis is not breast cancer; the breast cancer is where the cancer cells come from other organs.

Sample size calculation

We conducted a power analysis in Glimmpse (version 3.1.3; https://glimmpse.samplesizeshop.org/) with the following parameters: (1) a repeated measure design with 3 time points; (2) power = 80%; (3) significant level at 0.025 (= 0.05/2) to control the overall type 1 error to 5% for co-primary outcomes of FCRs in the couples; intra-correlation between repeated measures = 0.5; correlation of FCR between couple = 0.8; and same effect size on women and partners = 0.48 [23], yielded a sample size of 80. Further adding a 10% attrition rate, a total of 90 couples (i.e. 45 couples per group) will be recruited, with 70 couples in the hospital in the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, and 20 couples in the Affiliated Suzhou Hospital of Nanjing Medical University, to ensure representation from the lower-volume site.

Study procedures

Randomisation and blinding

After baseline assessment, couples will be randomly allocated to either the control group or the intervention group. A 1:1 allocation ratio with varying block sizes will be employed. A randomisation list will be generated using the online tool (http://www.randomization.com). A separate sequence of the group identifiers based on the computer-generated random codes will be prepared and placed in serially numbered opaque sealed envelopes before the start of the study. The procedure will be performed by a statistician who will not be included in subject recruitment or data analysis.

Recruitment, baseline assessment, and allocation

Convenience sampling will be employed for subject recruitment, with couples (a woman with breast cancer and her partner) as the sampling unit. A research assistant (RA1) will identify eligible women with breast cancer and their partners in the participating hospitals. Within each couple, the woman will be invited to complete the screening questionnaire (FoP-Q-SF) first. If the woman does not meet the eligibility criterion (i.e. FoP-Q-SF < 34), the other member will be invited to complete the same questionnaire. If the partner is not present in hospital when the woman’s FoP-Q-SF score is <34, RA1 will provide an electronic version of the questionnaire for the partner to complete via WeChat. Couples will be eligible if at least one member’s score ≥34. The study purpose and procedures will be explained to eligible couples, and written informed consent will be obtained from both members to indicate willingness to participate. For partners not present in hospital, written consent will be obtained via WeChat. After consent, a WeChat message with a Wenjuanxing hyperlink will be sent to each couple, who will complete the baseline (T0) electronic questionnaire independently. RA1 will open an envelope to perform group allocation after the couples complete the baseline questionnaires, and the couples will be provided with brief information about the logistics of the allocated group.

Study arms

Usual care

The usual care provides to breast cancer patients by the participating hospital includes routine inpatient and discharge education. Nurses or physicians of the hospitals provide a brief explanation about breast cancer and guidance for rehabilitation; however, detailed on-site education is not routinely practised due to the inadequate health workforce in the hospital.

Intervention: the theory-driven, disclosure-based family support programme plus usual care

On top of the usual care, the intervention group will receive the 6-week theory-driven, disclosure-based family support programme, delivered by a trained facilitator. The programme comprises an electronic educational package plus six sessions delivered via WeChat on a weekly basis, with each session lasting 40–60 min. The content of the family support programme was validated by a panel of five experts (CVI = 1.0). Session 1 includes a brief introduction to breast cancer, prevention, early recognition, and self-management of treatment side effects, particularly lymphedema. Session 2 includes education on physical activity and healthy dietary practices. Sessions 3–6 provide the disclosure, with session 3 additionally covering psychosocial factors related to breast cancer recurrence (Table 1). All sessions will be delivered to each couple independently. The electronic educational package includes materials on a brief introduction about breast cancer, self-management of treatment side effects, recommendations on a healthy diet and physical activity, and psychosocial factors related to cancer recurrence, in which pictures and a few words will be encompassed to enhance understanding. Besides, a brief overview of each disclosure session’s topic will also be displayed in the package. Each disclosure session between couples will last around 40–60 min with a trained facilitator and be audio-recorded. The disclosure sessions focus more on their treatment, breast cancer care after treatment, and psychological issues.

Table 1.

Components of theory-driven, disclosure-based family support programme

Sessions	Topic	Content
1	Brief introduction about breast cancer and self-management of treatment side effect, particularly lymphoedema	Breast cancer definition, risk factors, and prevalence; self-management of treatment side effects targeting to their treatment (surgery, chemotherapy, radiotherapy, hormone therapy, target therapy); prevention, early recognition, and self-management of lymphoedema
2	Healthy dietary education and physical activity education	Benefits of healthy dietary practice and physical activity Recommendations of nutrition and anti-cancer food, and physical activity Cautions on nutrition and physical activity Set goal plan for nutrition and physical activity
3	Communicating feelings	Expression of one’s feelings after the diagnosis of breast cancer, negative feelings and concerns of cancer progression Help patients to identify personal and psychosocial factors related to breast cancer recurrence, guide couples to use non-violent communication methods, encourage them to express their feelings and concerns in daily life and supplemented with some coping skills; couples are encouraged to express their emotions by using empathy, encouragement and inspiration, and promote the expression of negative emotions. Emphasise psychosocial factors, such as the relationship of negative emotion with breast cancer occurrence
4	Breast cancer influences	Talking about the effects that having breast cancer on personal life and family Talking about the details of worry or fear of recurrence and its influence The facilitator will explore couples’s perceptions of breast cancer prognosis, share cases and experiences of individuals with advanced stage but achieved good outcomes, and strengthen couples’ positive perceptions of prognosis. After the session, a video featuring a patient with advanced-stage cancer and a favourable outcome will be shared, and couples will be invited to discuss their reflections at the next session
5	Post-traumatic growth	Talking about what have been done/changed Talking about the worry and its influence Expressing concern and fear of cancer recurrence at the current stage The facilitator will ask couples to recall positive changes they have made, such as emotions, healthy diet, physical activity, sleep, and relationships with family members, and help women to deal with their treatment side effects. The facilitator will guide couples to think from each other’s side and promote intimate relationship within couples
6	Coping and expectation	Talking about the changes in couples’ perceptions of cancer recurrence Talking about the experience and coping strategies Talking about the future plans The facilitator will help women recall positive experience and their own coping strategies and will develop a plan to prevent cancer recurrence from five aspects, including cancer mindset, emotion, healthy diet, physical activity, and sleep

Control group

The control group will receive usual care plus 6 weekly follow-up WeChat calls, with each call lasting 5–10 min, to be delivered by another trained oncology nurse. No specific content will be designed, but they will be similar to usual care. Couples can raise whatever cancer-related questions they have. Guidance will be provided to the couples. If couples raise questions related to physical activity and a healthy diet, simple responses will be provided but not to the level of detail given to the intervention group. After completing the 12-week follow-up assessment, the electronic educational package will be offered to the control group without charge.

Data collection procedure

Data will be collected at three time points via WeChat: baseline (T0), 6 weeks (T1), and 12 weeks (T2). Details are shown in Table 2. A second research assistant (RA2), who is blinded to the group allocation, will send WeChat messages to couples containing a hyperlink to the questionnaire. Couples will complete and submit the questionnaire online via the link in the WeChat message. For the process evaluation, couples in the intervention group will be invited to join couple-based interviews about the acceptability of the intervention after completing the intervention at week 6 through WeChat calls. Each interview will last around 20 min.

Table 2.

Outcome assessment at the three time points by participant type

Outcome	Source of information	Time-point outcomes collected
Primary outcomes
FCR	Women + partners	T0, T1, and T2
Secondary outcomes
Social constraints	Women + partners	T0, T1, and T2
Intrusive thoughts	Women + partners	T0, T1, and T2
Avoidance	Women + partners	T0, T1, and T2
Anxiety	Women + partners	T0, T1, and T2
Stigma	Women + partners	T0, T1, and T2
Disclosure adherence	Women + partners in the intervention group	Sessions 4–6
Physical activity adherence	Women in the intervention group	Session 3–6
Healthy diet practice adherence	Women in the intervention group	Session 3–6
Acceptability of the intervention	Women + partners in the intervention group	T1

T0: baseline (T0): after recruitment; T1: 6 weeks after recruitment; T2: 12-week follow-up after recruitment

Measures

Co-primary outcomes

FCR

FCR will be measured using the Fear of Progression Questionnaire-Short Form (FoP-Q-SF) in women with breast cancer and their partners. The FoP-Q-SF is a 12-item self-report questionnaire that provides a multidimensional assessment of FCR [24]. The items are rated on a 5-point Likert scale ranging from 1 (never) to 5 (very often). The total score ranges from 12 to 60. A higher total score indicates a higher level of FCR, and scores of 34 or above were considered clinically significant FCR. The FoP-Q-SF has been translated into Chinese and rigorously validated, demonstrating good internal reliability, with Cronbach’s α of 0.886 for cancer patients and 0.853 for partners, respectively [25].

Co-secondary outcomes

• (i)Social constraints on disclosure

  For women with breast cancer, the social constraints will be assessed using the Lepore Social Constraints Scale, which measures social responses that inhibit the expression of cancer-specific thoughts, feelings, and experiences [26]. Participants will be asked to respond to 15 questions on a 1–4 Likert scale, ranging from 1 (never) to 4 (often), regarding their perception of constraining behaviours from their partners over the last 4 weeks. A total social constraints score is calculated by summing the scores of the 15 items, yielding a range of 15–60. High scores reflect high levels of overall social constraints during the communication process. The scale has been translated into Chinese and rigorously validated among Chinese women with breast cancer, with Cronbach’s alpha of 0.91 [27].

  For partners, social constraints will be measured using the adapted Simplified Chinese version of the Social Constraints Scale for partners of adults with cancer [28]. This 15-item scale includes three dimensions: alienation (11 items), health concern minimisation (2 items), and emotional concealment (2 items). As with the Social Constraints Scale for women, each item is rated on a 4-point Likert scale from 1 (never) to 4 (often). The total score ranges from 15 to 60, with high scores indicating greater social constraints. Cronbach’s alpha values of the overall scale and three dimensions ranged from 0.719 to 0.863.

• (ii)Intrusive thoughts and avoidance

  Intrusive thoughts and avoidance will be measured with two subscales of the Impact of Event Scale-Revised (IES-R) [29]. The IES-R comprises 22 items measuring three dimensions: intrusive thoughts (eight items), avoidance (six items), and arousal (eight items). Participants respond to the 14 items of the intrusive thoughts and avoidance subscales on a 0–4 Likert scale (0 = ‘not at all’ to 4 = ‘extremely’). Total scores for intrusive thoughts and avoidance can range from 0 to 32 and 0 to 24, respectively, with higher scores reflecting greater levels of intrusive thoughts and avoidance. This Chinese version of the IES-R has been used in breast cancer population and their partners, with Cronbach’s α value of 0.9 and 0.85 for women with breast cancer and for their male partners, respectively [30].

• (iii)Anxiety

  Anxiety will be assessed using the Generalised Anxiety Disorder scale (GAD-7), a 7-item self-report instrument used to evaluate respondents’ experience of anxiety [31]. Respondents are asked how often they had been bothered by the seven core symptoms of GAD over the past 2 weeks. The total score of the GAD-7 ranges from 0 to 21, with higher scores indicating greater levels of anxiety. The Chinese version of GAD-7 has been validated and demonstrates good internal consistency, with a Cronbach’s alpha of 0.898 [32].

• (iv)Stigma

  For women with breast cancer, stigma will be measured with the Chinese version of the Breast Cancer Stigma Scale [33]. This scale is a 15-item self-report questionnaire that provides a multidimensional assessment of stigma, comprising four dimensions: self-image impairment (5 items), internalised stigma (4 items), social isolation (2 items), and discrimination (4 items). The items are rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 15 to 60, and high scores indicate high levels of stigma. The Chinese version of the scale has demonstrated good internal reliability, with a Cronbach’s α of 0.86 for women with breast cancer [33].

  For partners, affiliate stigma will be measured using the Chinese version of the Affiliate Stigma Scale for Caregivers of Women with Breast Cancer [34]. This 24-item scale provides a multidimensional assessment of affiliate stigma in caregivers of women with breast cancer, comprising four dimensions: internal stigma (7 items), social isolation (8 items), perceived stigma (4 items), and reaction (5 items). Each item was rated on a 4-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 24 to 96, with high scores indicating high levels of stigma. The Chinese version of the scale has demonstrated good internal reliability, with a Cronbach’s α of 0.932 for caregivers of women with breast cancer [34].

Secondary outcomes of adherence

Adherence of disclosure within couples in the intervention group

Couples will be required to share their feelings, thoughts, worries, and concerns with each other three times per week, with each lasting approximately 15 min. Adherence to disclosure will be recorded from session 4 to session 6.

Adherence to physical activity and healthy dietary in women

Adherence to physical activity and healthy dietary tasks in women will be recorded from session 3 to session 6, yielding four adherence records for each woman. Based on the findings from our pilot test among 15 couples [18], the criterion for adherence to physical activity will be ‘walking for at least 30 min on 5 days per week’. This criterion is adopted for safety and protocol consistency because the study will take place during the summer months when ambient temperatures reach 37–42 °C. Postoperative women will be advised against engaging in strenuous exercise to avoid sweating and an increased risk of surgical site infection. In addition, some women may undergo autologous breast reconstruction, during which surgical drains may remain in situ for prolonged periods, making vigorous or high-impact exercise inappropriate. Although adults aged 18–64 years are generally recommended to achieve at least 150 min of moderate-intensity exercise or 75 min of vigorous-intensity aerobic exercise per week, our trial-specific adherence criterion is therefore walking for at least 30 min on 5 days per week.

For adherence to healthy dietary practice, women will be advised to follow ‘Chinese Balanced Diet Pagoda’ and Guidelines and Norms for Diagnosis and Treatment of Breast Cancer of the Chinese Anti-Cancer Association to appropriately distribute food portions across three daily meals.

Physical activity adherence and healthy dietary adherence will not be recorded in the control group because (1) goal plans regarding exercise and healthy dietary adherence will not be set with control couples and (2) information on physical activity and a healthy diet will be provided upon request. If administering the adherence items to the control group may prompt control participants to seek information and change behaviour, it may thereby introduce contamination to the study findings.

Demographic and disease-related characteristics

For women with breast cancer, variables of cancer stage, recurrent status, time since diagnosis, current treatment, age, educational level, employment status, place of residence, and whether cohabitation with a partner will be collected at baseline assessment. For the partner, variables of age, educational level, and employment status will be collected at baseline assessment.

Data management and analysis

RA2 will download the dataset from the Wenjuanxing platform and provide it to the researcher without group allocation information, ensuring that the researcher remains blinded during data analysis. Quantitative data will be analysed by SPSS 26.0. Descriptive analysis will be computed separately at baseline, post-intervention, and follow-up. The intention-to-treat principle will be applied whenever applicable. The descriptive analysis results will be reported as means and standard deviations for continuous variables, whereas counts and percentages for categorical variables. For demographic, disease-related, and dyad-reported variables, independent sample t-tests for continuous variables and chi-square tests for categorical variables will be used to check the baseline comparability between the two groups by randomisation. To assess the effect of the intervention on the dyad-reported outcomes, generalised linear mixed model (GLMM) will be conducted to take account of the dependence of the outcomes in the dyad. Adherence to disclosure, physical activity, and healthy dietary practice in the intervention group will be reported as counts and percentages.

For qualitative data, audio recordings will be transcribed verbatim within 24 h by the researcher and double-checked by RA1, both of whom were trained in qualitative methods. Transcripts will be organised and coded using NVivo software version 11 (https://lumivero.com/products/nvivo/). Thematic analysis will be undertaken to explore the acceptability of the intervention [35]. Trustworthiness of the data will be enhanced through member checking with participants.

Quality control

To avoid potential contamination across study arms in the hospitals, one woman-partner dyad will be recruited in each of the cubicles within each ward, with no new couples being recruited before the woman is discharged. Because chemotherapy appointments may recur and overlap, women receiving chemotherapy in the day-case ward will be advised to attend at staggered times. For hospitalised women, we will coordinate with physicians to allocate them to different wards wherever feasible. In addition, couples in both arms will be asked not to share or discuss the intervention or control procedures with others during their hospital stay.

Before the start of subject recruitment, the two facilitators, who are oncology nurses, will be trained. The facilitator delivering the family support programme will receive training from a psychologist with over 10 years of clinical experience in oncology and extensive practice in facilitating disclosure. The facilitator delivering the follow-up WeChat calls will be trained by the researcher. Intervention fidelity will be assessed using a self-developed checklist addressing the distribution of electronic handbook materials, duration of intervention delivery, delivery of all contents in each session according to the session plan, delivery mode, and implementation of disclosure between couples. Three possible responses will be given (yes/no/not applicable). All the sessions will be recorded, and a senior registered oncology nurse will fill the checklist for at least 10% of the total sessions. The percentage of accomplishment will be calculated. Reasons for implementation gaps will be recorded. Feedback from participants in the intervention group will be also collected during the intervention period.

Discussion

This protocol outlines a multi-centre RCT to evaluate a theory-driven, disclosure-based family support programme for reducing FCR in couples coping with breast cancer. Grounded in Simonelli’s integrative model, the family support programme targets three modifiable factors affecting individual’s cognitive processing and appraisal, including social constraints on disclosure, physical symptoms/treatment sides, and history of coping.

Social constraints are a modifiable factor of greater FCR common to both women with breast cancer and their partners [1, 36]. When either women or partners feel constrained in discussing breast cancer-related issues, cognitive processing of the cancer experience is impeded, which is associated with more intrusive thoughts and avoidance and, in turn, greater FCR [37]. Targeting social constraints on disclosure in both members of the dyad is therefore expected to reduce FCR concurrently. Couple-based interventions are particularly well suited to reduce inhibited disclosure because they can address social constraints, protective buffering, and the reciprocal roles of both partners in maintaining these patterns [1, 8]. By fostering a more supportive disclosure environment, couples will be better able to share concerns, fears, and worries, which may reduce FCR in both parties.

Beyond social constraints on disclosure, Simonelli’s integrative model highlights other modifiable factors, such as management of physical symptoms and side effects of treatments and coping that may further reduce FCR. Incorporating these elements alongside facilitated disclosure is therefore hypothesised to be more effective than disclosure alone. This theory-guided design aligns with the updated Medical Research Council guidance for developing and evaluating complex interventions, which emphasises explicit articulation of intervention components, mechanisms, contextual influences, and their expected interactions [38].

The result of this study will inform clinicians, researchers, and policymakers about FCR management and the value of the couple-based management approach. The finding of this trial will also support the consideration of couple-based interventions to improve FCR among women with breast cancer and their partners. If the theory-driven, disclosure-based programme proves effective, it could reduce FCR in both members of the couple and equip them with practical knowledge and skills for managing recurrence-related concerns.

Strengths

This study has several strengths. First, it is the first study to test a theory-driven, disclosure-based family support programme to alleviate FCR in couples coping with breast cancer, which will address the paucity of caregiver-focused interventions. Second, the family support programme is grounded in Simonelli’s integrative model and literature, and its effectiveness will be rigorously tested with a RCT, ensuring evidence-based findings. Thirdly, social media has become increasingly popular in recent years. This study will deliver the intervention via WeChat, which may provide couples with a convenient, low-burden mode of participation. Fourthly, this study will be a multi-centre RCT, enhancing generalisability by recruiting participants across sites. Lastly, a qualitative process evaluation will provide in-depth feedback on the family support programme, improving understanding of how the intervention operates within couples.

Limitations

This study also has some limitations. Even though the intervention development is guided by Simonelli’s integrative model, not all the components of the model have been included due to the scope of the study. Besides, this study focuses on couples of women with breast cancer and their partners who are smartphone users. There are still some couples who do not have smartphones such as those who have low incomes, and hence the results may not be applicable to those in low/middle-income countries.

Conclusion

This study will provide rigorous evidence on the effectiveness of the family support programme on FCR for couples coping with breast cancer. Family-based supportive-oncology programmes, such as the family support programme, that provide educational content on breast cancer-related knowledge, physical activity, healthy diet, psychosocial factors related to breast cancer recurrence, and disclosure in a supportive environment, may be a viable option to reduce FCR, social constraints, and foster cognitive processing for couples coping with breast cancer. This work will address the research gap that limited evidence for interventions that alleviate FCR in caregivers of women with breast cancer.

Trial status

The current protocol is version 2 of Sep 2024. The trial status is currently in the follow-up data collection phase. Recruitment started in Sep 2024 and completed in Nov 2024. We have submitted the manuscript to BMJ OPEN on 13 Nov 2024, but the journal failed to find reviewers, and hence we have withdrawn the submission in early March 2025 and it was approved by BMJ OPEN on 13 March 2025.

Abbreviations

FCR

Fear of cancer recurrence

RCT

Randomised controlled trial

RA

Research assistant

FoP-Q-SF

Fear of Progression Questionnaire-Short Form

IES-R

Impact of Event Scale-Revised

GAD-7

Generalised Anxiety Disorder scale

GLMM

Generalised linear mixed model

Authors’ contributions

XB is the principal investigator, formulated the research question, conceptualised the study design, conceived, and contributed to the manuscript. DL supervises all the activity, formulated the research question, conceptualised the study design, conceived, and contributed to the manuscript. JC supervises part of the activity and contributed to the manuscript. XL and LJ are co-investigators, coordinate subject recruitment at study sites, and contributed to the manuscript. CJ is a co-investigator, contributed to the manuscript, and provided financial support to this study. All authors have read and approved the manuscript.

Funding

None.

Data availability

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

This study protocol was approved by the Human Subjects Ethics Sub-committee of the Hong Kong Polytechnic University (HSEARS20240202001). The study will be conducted in accordance with the Declaration of Helsinki. Informed written consents will be obtained from all the participants before data collection.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.