2.2 Intervention

Flexible Coping with Sexual Concerns provides the philosophical underpinning of the proposed MCI. It enables responsive intervention delivery, adapted to need, by expanding the conceptualisation of sexual function and activity, adopting positive coping strategies, and shifting the focus on sexual functioning to intimacy, subsequently bringing beneficial effects on sexual adjustment and relationship satisfaction [27]. It is posited that a discussion of flexibility in coping with sexual health concerns early in the treatment trajectory facilitates sexual adjustment and the renegotiation of intimate relationships during survivorship. The intervention components integrate evidence-based techniques from cognitive behavioural couple therapy and sex therapy for intimacy enhancement [28], combined with psychoeducation, skills training and therapeutic counselling [22], in order to motivate beneficial cognitive and behavioural changes in sexual function and activity [27]. With flexible coping with sexual concerns, individuals can think about sexual activity differently and engage in attainable sexual activities to maintain and foster intimacy [27]. The causal model is illustrated in Fig 2.

Open in a separate window

Fig 2

The conceptual framework of the multimodal couple-coping intervention.

Note: This conceptual framework is adapted from the Model of Flexible Copying with Sexual Concerns (Reese et al., 2010).

According to the model, a more flexible perception of sexuality for individuals who may not be able to resume or engage in their previous level and type of sexual activity is beneficial. In the context of BRC, enhancing the level of flexibility among women treated for BRC and their partners has the potential to promote their sexual adjustment, improve relationship quality and QoL. To increase flexibility, the intervention will adopt three strategies: expanding conceptualisation of sexual function and activity, adopting positive coping strategies, and focusing on intimacy [27]. The components of the MCI include psychoeducation, skills training and therapeutic counselling with the integration of techniques from cognitive behavioural couple therapy and sex therapy [22, 28]. The contents and design of the intervention are also guided by the findings of previous studies [20, 22, 27, 28], and the successful completion of the project led by the authors in which factors that might enhance the provision of sexuality care and the information needs of sexual health and preferences for sexuality care of female gynaecological cancer patients were identified [29]. The information needs include the possibility and suitable timing of sex life resumption, its potential impact on physical health, adaptation to changes in sex life, and potential impact of disease and treatment on physical, psychological and sexual functioning. Regarding the format, the participants indicated the preference for face-to-face counselling with partner participation during post-operation and rehabilitation, and information delivered via the internet with reading materials [29].

The proposed MCI is an eight-week five-session programme, each session delivered every two weeks (at Weeks 0, 2, 4, 6, and 8), covering topics on the impact of BRC on sex and intimacy, communication and problem-solving skills, dyadic positive coping, cognitive restructuring of sex and intimacy, intimacy-building activities, and maintaining intimacy [20, 22, 27–29]. The first and last sessions will be conducted in face-to-face dyad format, the second session will be virtual dyad counselling, the third one will be online reading with a chat-based discussion forum and homework exercise, and the fourth will be a reminder telephone call for reviewing what has been achieved and scheduling the last session. The counselling sessions will last for 60–90 minutes and will be delivered by a full-time research nurse who will receive one-week of training from the first author to provide the intervention, while the online discussion will be moderated by the research nurse to monitor the progress of online reading. The telephone call will last for around 30 minutes. The components and contents of the MCI are listed in Fig 2 and Table 1.

2.3. Study setting and participants

We will recruit women treated for BRC and their partners in the oncology clinics of three regional hospitals in Hong Kong during their regular follow-ups. The inclusion criteria include (1) women with a diagnosis of BRC; (2) all active treatment completed in the previous six months but endocrine and/ or maintenance therapy allowed with no evidence of metastatic disease, so that the intervention will be delivered to them during early survivorship, with the intent to prepare the women and their partners for life after cancer; (3) with a regular sexual partner, either heterosexual or homosexual; (4) over 18 years; (5) in a premenopausal state when diagnosed with BRC; (6) has a smartphone with internet connection; (7) able to understand spoken Cantonese and to read Chinese; (8) consenting to participate. Those with a known pre-existing psychiatric illness were excluded.

The sample size will adequately power the study to evaluate the effects of the MCI on the outcomes of sexual adjustment, relationship quality and QoL. To our knowledge, no study has investigated the effects of a multimodal couple-based intervention on sexual health outcomes. Without an empirically-derived effect size to guide our sample size planning, we instead define a clinically-relevant change as a 0.5 standard deviation (SD) improvement in the above outcomes on an a priori basis. Such an effect corresponds to a medium effect size [30] and is empirically regarded as a minimally important difference [31]. By using the power analysis software PASS 16 (NCSS, LLC. Kaysville, Utah, USA), it is estimated based on an independent t-test that a sample size of 64 dyads per group is adequate to achieve 80% power at a two-sided 5% level of significance to detect an effect size of 0.5 SD in an outcome at a post-intervention time point. Further allowing for an overall attrition rate up to 20% [22], a total of 160 eligible dyads, with 80 per group will be recruited into the RCT.

2.4 Recruitment

A research nurse will approach eligible women and their partners in the oncology clinic during the period of 1 November 2023 to 31 December 2024 and explain the aims of the study to them. Information sheets about the study and consent forms will be provided. After written consent is obtained, the participating dyad’s demographic data will be collected, and the instruments will be administered during baseline face-to-face interviews before randomisation.

2.5 Randomisation and blinding

The participants will be randomly assigned to either the intervention or attention control groups. Subject allocation will be performed using stratified block randomisation with a block size of 10. A random sequence of grouping identifiers (I or C) based on computer-generated random numbers will be prepared in advance by an independent statistician for each oncology clinic. The grouping sequence lists will be password-protected and stored in a computer, and only be accessible to staff independent of the study or responsible for group allocation. The group allocation of each participant will be assigned according to the sequence of enrolment and the corresponding group identifier in the prior prepared random sequence list.

To guarantee that the outcome assessor is blinded, a research assistant who is uninformed about the group status of the participants will be responsible for conducting reassessments. Reassessment will be conducted at the same time point for both groups, i.e., on the completion of the intervention, three months and six months post-intervention via telephone call. Participating dyads in the intervention group will be invited to be interviewed about their experiences and feelings towards the intervention. Another research nurse will perform qualitative interviews with the participating dyads to avoid an experimenter effect.

2.6 Control intervention

While the participants in the intervention group will receive the MCI, those in the attention control group will receive attention from the research nurse five times during the same period as the intervention group to prevent bias from the special attention given. The research nurse will only approach the participants to invite them to participate in the study and collect baseline data, but they will not provide any form of intervention to them. The research nurse will contact the participants through phone calls at weeks 2, 4, 6, and 8, where they will deliver general greetings and provide general advice.

2.7 Outcome measures

2.8 Data collection procedure

A research nurse will be responsible for subject recruitment, randomisation, and baseline assessment which uses the socio-demographic and clinical characteristics, the Chinese version of the SABIS, EMS, and SF-36v2. The SABIS, EMS, and SF-36v2 will be reassessed immediately after the completion of the programme, three months and six months post-intervention. To ensure an unbiased assessment, a research assistant who is unaware of the participants’ group assignment will conduct phone interviews for the reevaluation. Another research nurse will be responsible for conducting semi-structured interviews with participants in the intervention group immediately after the final session of the programme (Fig 1).

2.9 Data analysis

Data will be summarised and presented using appropriate descriptive statistics. Continuous and categorical data will be presented in mean (standard deviation) and frequency (percentage), respectively. The homogeneity of participants’ characteristics between the two study arms will be assessed using independent t, Mann-Whitney, chi-square or Fisher’s exact tests, as appropriate. Intention-to-treat principle will be adopted in the outcome analysis by using a generalised estimating equations (GEE) model to compare the differential changes in each outcome across the four time points between the two arms with adjustment for the stratifying factor (oncology clinic). The interventional effects on the outcomes are indicated by the group-by-time interaction terms in the GEE analyses. All statistical analyses will be performed using IBM SPSS version 28 (IBM Crop., Armonk, NY). All statistical tests are two-sided with level of significance set at 0.05.

Audiotapes of the interviews will be examined by means of thematic analysis. First, the recorded tapes will be transcribed verbatim. All transcripts will be compared with the recording to check for any discrepancies and revised as necessary. The transcripts will then be content analysed to identify persistent words and code themes within the data. Lastly, significant categories, theoretical themes and linkages within the data will be formulated and confirmed by the first author and a co-author to improve its accuracy, and then translated into English [35].

2.10 Validity and reliability

This protocol has been reviewed and approved by the General Research Fund (GRF) of the Research Grants Council of Hong Kong. The effects of this evidence-based and theory-guided intervention will be evaluated by the gold standard research design (RCT), using validated instruments and appropriate statistical analysis. The assessor will be blinded to ensure that outcomes are evaluated objectively and independently. These practices will enhance the validity and reliability of the study findings, reducing potential bias and enhancing generalisation.