Opening the Conversation Study
- Conditions
- Breast CancerGynecologic Cancer
- Interventions
- Behavioral: Side by SideBehavioral: Opening the Conversation
- Registration Number
- NCT04806724
- Lead Sponsor
- Oregon State University
- Brief Summary
Young adult survivors of breast and gynecologic cancer face a number of challenges, including interrupted life plans. As many as two-thirds of these young survivors experience negative effects of cancer and cancer treatment on their reproductive health, including sexual function and ability to have children. These are among the most distressing aspects of life after cancer for young survivors and their partners, and when left unaddressed, lead to poorer mental health and quality of life. Yet, surprisingly, evidence-based programs are not available to help young couples manage this aspect of life after cancer. In this study, we will adapt and evaluate an intervention designed to help young couples cope with and communicate about cancer-related reproductive and sexual health concerns.
- Detailed Description
The specific aims of the study are:
Aim 1 (Phase I). Systematically adapt an empirically supported couple-based skills training intervention to help young breast and gynecologic cancer (BGC) survivors and their partners jointly manage the reproductive and sexual health consequences of cancer.
Aim 2 (Phase II - Quantitative). Evaluate the efficacy of the intervention and hypothesized mediators by conducting a randomized trial. We will evaluate the efficacy of the newly adapted intervention, Opening the Conversation (OC), on survivors' and their partners' reproductive and sexual distress as well as the relationship, sexual, and psychosocial health outcomes. We will determine whether dyadic coping and communication mediate intervention effects on survivors' and partners' reproductive and sexual distress.
Aim 3 (Phase II - Qualitative). Evaluate couples' experiences within and across conditions to gain in-depth knowledge of intervention components that influence hypothesized mediators and outcomes.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Cancer survivor participants:
- Cancer diagnosis between ages 18-39 years
- Current age 18-44
- Cancer diagnosis 6 months-5 years prior to enrollment
- Diagnosed with breast and/or gynecologic cancer
- Cancer stage 1-4
- Ability to participate in a videoconference intervention
- Has committed partner willing to participate
- English speaking
- High speed internet access via smart phone, tablet and/or computer
Partner participants:
- Age 18 or older
- English speaking
- Ability to participate in a videoconference intervention
- High speed internet access via smart phone, tablet and/or computer
-Cancer survivors and partners are excluded if either partner does not meet eligibility criteria. Both partners must enroll or the dyad will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Program #2 Side by Side Participants attend 4 sessions (1.5 hours each) consisting of education and skills training to address cancer-related concerns. Sessions occur via videoconference. Program #1 Opening the Conversation Participants attend 5 sessions (1.5 hours each) consisting of education and skills training to address cancer-related reproductive and sexual health concerns. Sessions occur via videoconference.
- Primary Outcome Measures
Name Time Method Change in reproductive distress Baseline to 3 months post-intervention Relationship concern domain of the Fertility Problem Inventory (FPI) scale. 10 items. Range 10-60. Higher score indicates more reproductive distress.
Change in sexual distress Baseline to 3 months post-intervention Sexual and relationship distress (SaRDS). 30 items. Range 1-30. Higher score indicates more sexual distress.
- Secondary Outcome Measures
Name Time Method Change in relationship quality Baseline to 3 months post-intervention Dyadic Adjustment Scale (DAS-7). 7 items. Range 0- 36. Higher score indicates higher relationship quality.
Change in relationship Intimacy Baseline to 3 months post-intervention Miller Social Intimacy Scale (MSIS). 17 items. Range 17-170. Higher score indicates higher levels of intimacy.
Change in sexual function (female) Baseline to 3 months post-intervention. Female Sexual Function Index (FSFI).19 items. Range 2-36. Higher score indicates higher functioning.
Chang in sexual function (male) Baseline to 3 months post-intervention International Index of Erectile Function (IIEF). 15 items. Range 1-75. Higher score indicates a higher level of sexual functioning.
Change in global sexual satisfaction Baseline to 3 months post-intervention Global Measure of Sexual Satisfaction (GMSEX). 5 items. Higher score indicates higher level of sexual satisfaction.
Change in depressive symptoms Baseline to 3 months post-intervention Patient Health Questionnaire (PHQ-8).8 items. Range 0 -24. Higher score indicates higher levels of depression.
Change in global health-related quality of life Baseline to 3 months post-intervention PROMIS Global 10 v1.2. Raw scores (range 10-50) are translated to T scores following PROMIS guidelines. Higher score indicates better functioning.
Change in self-efficacy to communicate about sex and intimacy (survivor only) Baseline to 3 months post-intervention SECSI. 10 items. Range 0-30. Higher score indicates higher self-efficacy.
Trial Locations
- Locations (1)
Oregon State University
🇺🇸Corvallis, Oregon, United States