Opening the Conversation Study

Oregon State University (OSU)

Status: Active, not recruiting

Conditions: Breast Cancer; Gynecologic Cancer

Treatments: Behavioral: Opening the Conversation; Behavioral: Side by Side

Study type: Interventional

Funder types: Other

Identifiers

NCT04806724

7621 HE-2022-41;

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Program #1

Experimental group

Description:

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.

Treatment:

Behavioral: Opening the Conversation

Program #2

Active Comparator group

Description:

Participants attend 4 sessions (1.5 hours each) consisting of education and skills training to address cancer-related concerns. Sessions occur via videoconference.

Treatment:

Behavioral: Side by Side