Breast Cancer Clinical Trial
Opening the Conversation Study
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
-Cancer survivors and partners are excluded if either partner does not meet eligibility criteria. Both partners must enroll or the dyad will be excluded.
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