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A multimodal couple-coping intervention for enhancing sexual adjustment among breast cancer women: Study protocol for a randomised controlled trial.

ABSTRACT: To investigate the effects of a multimodal couple-based sexual health intervention for premenopausal women treated for breast cancer and their partners to provide personalised psychosexual care, and to understand participants' experience of, and adherence to, the intervention. This is an assessor-blinded, randomised controlled trial. Premenopausal women treated for breast cancer (N = 160) and their partners will be recruited. Dyads will be randomised into an intervention (n = 80) or attention control (n = 80) group. The intervention group will receive the multimodal couple-based sexual health intervention over eight weeks. The intervention comprises five face-to-face and virtual individual couple counselling sessions combined with online reading, a chat-based discussion forum, and telephone calls. The intervention is based on level I-II evidence and a robust theoretical framework. The attention control group will receive usual care plus telephone calls comprising general greetings and reminders to complete follow-up surveys. Sexual adjustment, relationship quality and quality of life will be measured at baseline, after completion of the intervention, three months and six months post-intervention. The project will adhere to the CONSORT-EHEALTH checklist. Qualitative interviews will explore the participants' experience of, and adherence to, the intervention. This study will provide the first pragmatic evidence of the effectiveness of a multimodal couple-coping intervention to support premenopausal women and their partners to improve sexuality, relationship quality and quality of life after treatment for breast cancer. Sexual health is a neglected area in clinical practice, for patients and partners. The ever-growing population of women treated for breast cancer at younger age has created a more pressing need for the development of tailored sexual health interventions. If effective, this intervention could be incorporated into routine cancer care to provide better support and care for this patient population to enhance sexual health, intimacy and overall well-being. ISRCTN35481498; prospectively registered on 08/05/2023.

SUBMITTER: Chow KM

PROVIDER: S-EPMC11340947 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

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A multimodal couple-coping intervention for enhancing sexual adjustment among breast cancer women: Study protocol for a randomised controlled trial.

Chow Ka Ming KM Chan Carmen Wing Han CWH Choi Kai Chow KC McCarthy Alexandra Leigh AL

PloS one 20240822 8

<h4>Aim</h4>To investigate the effects of a multimodal couple-based sexual health intervention for premenopausal women treated for breast cancer and their partners to provide personalised psychosexual care, and to understand participants' experience of, and adherence to, the intervention.<h4>Methods</h4>This is an assessor-blinded, randomised controlled trial. Premenopausal women treated for breast cancer (N = 160) and their partners will be recruited. Dyads will be randomised into an interventi ...[more]

PMID: 39172959

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Project description:IntroductionType 2 diabetes is prevalent among US adults. Lifestyle interventions that modify health behaviours prevent or delay progression to diabetes among individuals at high risk. Despite the well-documented influence of individuals' social context on their health, evidence-based type 2 diabetes prevention interventions do not systematically incorporate participants' romantic partners. Involving partners of individuals at high risk for type 2 diabetes in primary prevention may improve engagement and outcomes of programmes. The randomised pilot trial protocol described in this manuscript will evaluate a couple-based lifestyle intervention to prevent type 2 diabetes. The objective of the trial is to describe the feasibility of the couple-based intervention and the study protocol to guide planning of a definitive randomised clinical trial (RCT).Methods and analysisWe used community-based participatory research principles to adapt an individual diabetes prevention curriculum for delivery to couples. This parallel two-arm pilot study will include 12 romantic couples in which at least one partner (ie, 'target individual') is at risk for type 2 diabetes. Couples will be randomised to either the 2021 version of the CDC's PreventT2 curriculum designed for delivery to individuals (six couples), or PreventT2 Together, the adapted couple-based curriculum (six couples). Participants and interventionists will be unblinded, but research nurses collecting data will be blinded to treatment allocation. Feasibility of the couple-based intervention and the study protocol will be assessed using both quantitative and qualitative measures.Ethics and disseminationThis study has been approved by the University of Utah IRB (#143079). Findings will be shared with researchers through publications and presentations. We will collaborate with community partners to determine the optimal strategy for communicating findings to community members. Results will inform a subsequent definitive RCT.Trial registration numberNCT05695170.

Project description:BackgroundSexual concerns are distressing for breast cancer survivors and interfere with their intimate relationships. This study evaluates the efficacy of a four-session couple-based intervention delivered via telephone, called Intimacy Enhancement (IE). The IE intervention is grounded in social cognitive theory and integrates evidence-based techniques from cognitive behavioral couple therapy and sex therapy to address survivors' sexual concerns and enhance their and their partners' sexual, relationship, and psychological outcomes.MethodsThis trial is designed to evaluate the efficacy of the IE intervention in improving survivors' sexual function, the primary study outcome. Secondary outcomes include survivors' sexual distress, partners' sexual function, and survivors' and partners' relationship intimacy and quality as well as psychological distress (depressive symptoms and anxiety symptoms). Additional aims are to examine whether treatment effects on patient sexual function are mediated by sexual communication and self-efficacy for coping with sexual concerns and to explore whether survivor age and race/ethnicity moderate intervention effects on survivors' sexual function. Eligible adult female breast cancer survivors reporting sexual concerns and their intimate partners are recruited from two academic sites in the USA and are randomized to either the IE intervention or to a control condition of equal length offering education and support around breast cancer-related health topics (Living Healthy Together). The target sample size is 120 couples. Self-report outcome measures are administered to participants in both conditions at baseline (T1), post-treatment (T2), 3 months post-treatment (T3), and 6 months post-treatment (T4).DiscussionEvidence-based interventions are needed to address sexual concerns for breast cancer survivors and to enhance their and their intimate partners' sexual, relationship, and psychological well-being. This randomized controlled trial will allow us to examine the efficacy of a novel couple-based intervention delivered via telephone for breast cancer survivors experiencing sexual concerns and their intimate partners, in comparison with an attention control. Findings of this study could influence clinical care for women with breast cancer and inform theory guiding cancer-related sexual rehabilitation.Trial registrationClinicalTrials.gov, NCT03930797. Registered on 24 April 2019.

Project description:BackgroundAddressing sexual trauma in the context of HIV care is essential to improve clinical outcomes and mental health among women in South Africa. Women living with HIV (WLH) report disproportionately high levels of sexual trauma and have higher rates of posttraumatic stress disorder. Adherence to antiretroviral therapy (ART) may be difficult for traumatized women, as sexual trauma compounds the stress associated with managing HIV and is often comorbid with other mental health disorders, further compromising care engagement and adherence. ART initiation represents a unique window of opportunity for intervention to enhance motivation, increase care engagement, and address the negative effects of trauma on avoidant coping behaviors. Mental health interventions delivered by non-specialists in low- and middle-income countries have potential to treat depression, trauma, and effects of intimate partner violence among WLH. This study will examine the effectiveness of Improving AIDS Care after Trauma (ImpACT +), a task-shared, trauma-focused coping intervention, to promote viral suppression among WLH initiating ART in a South African clinic setting.MethodsThis study will be conducted in Khayelitsha, a peri-urban settlement situated near Cape Town, South Africa. Using a hybrid type 1 effectiveness-implementation design, we will randomize 350 WLH initiating ART to the ImpACT + experimental condition or the control condition (three weekly sessions of adapted problem-solving therapy) to examine the effectiveness of ImpACT + on viral suppression, ART adherence, and the degree to which mental health outcomes mediate intervention effects. ImpACT + participants will receive six once-a-week coping intervention sessions and six monthly maintenance sessions over the follow-up period. We will conduct mental health and bio-behavioral assessments at baseline, 4, 8, and 12 months, with care engagement data extracted from medical records. We will explore scalability using the Consolidated Framework for Implementation Research (CFIR).DiscussionThis trial is expected to yield important new information on psychologically informed intervention models that benefit the mental health and clinical outcomes of WLH with histories of sexual trauma. The proposed ImpACT + intervention, with its focus on building coping skills to address traumatic stress and engagement in HIV care and treatment, could have widespread impact on the health and wellbeing of individuals and communities in sub-Saharan Africa.Trial registrationClinicaltrials.gov NCT04793217 . Retrospectively registered on 11 March 2021.

Project description:BackgroundSexual and gender minority youth (SGMY, aged 14-29 years) face increased risks to their well-being, including rejection by family, exclusion from society, depression, substance use, elevated suicidality, and harassment, when compared with their cisgender, heterosexual peers. These perils and a lack of targeted programs for SGMY exacerbate their risk for HIV and other sexually transmitted infections. Cognitive behavioral therapy (CBT) interventions support clients by generating alternative ways of interpreting their problems and beliefs about themselves. CBT, tailored to the experiences of SGMY, may help SGMY improve their mood and coping skills by teaching them how to identify, challenge, and change maladaptive thoughts, beliefs, and behaviors. Based on the promising results of a pilot study, a CBT-informed group intervention, AFFIRM, is being tested in a pragmatic trial to assess its implementation potential.ObjectiveThe aim of this study is to scale-up implementation and delivery of AFFIRM, an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviors and psychosocial distress among SGMY. Our secondary aim is to decrease sexual risk taking, poor mental health, and internalized homophobia and to increase levels of sexual self-efficacy and proactive coping among SGMY.MethodsSGMY are recruited via flyers at community agencies and organizations, as well as through Web-based advertising. Potential participants are assessed for suitability for the group intervention via Web-based screening and are allocated in a 2:1 fashion to the AFFIRM intervention or a wait-listed control in a stepped wedge wait-list crossover design. The intervention groups are hosted by collaborating community agency sites (CCASs; eg, community health centers and family health teams) across Ontario, Canada. Participants are assessed at prewait (if applicable), preintervention, postintervention, 6-month follow-up, and 12-month follow-up for sexual health self-efficacy and capacity, mental health indicators, internalized homophobia, stress appraisal, proactive and active coping, and hope. Web-based data collection occurs either independently or at CCASs using tablets. Participants in crisis are assessed using an established distress protocol.ResultsData collection is ongoing; the target sample is 300 participants. It is anticipated that data analyses will use effect size estimates, paired sample t tests, and repeated measures linear mixed modeling in SPSS to test for differences pre- and postintervention. Descriptive analyses will summarize data and profile all variables, including internal consistency estimates. Distributional assumptions and univariate and multivariate normality of variables will be assessed.ConclusionsAFFIRM is a potentially scalable intervention. Many existing community programs provide safe spaces for SGMY but do not provide skills-based training to deal with the increasingly complex lives of youth. This pragmatic trial could make a significant contribution to the field of intervention research by simultaneously moving AFFIRM into practice and evaluating its impact.International registered report identifier (irrid)DERR1-10.2196/13462.

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A multimodal couple-coping intervention for enhancing sexual adjustment among breast cancer women: Study protocol for a randomised controlled trial.

Publications

A multimodal couple-coping intervention for enhancing sexual adjustment among breast cancer women: Study protocol for a randomised controlled trial.

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