Clinical trial NCT04806724: Opening the Conversation Study
Official title: Opening the Conversation for Couples With Reproductive Health Concerns
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Gynecologic Cancer
Lead sponsor: Oregon State University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2021-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in reproductive distress
timeFrame: Baseline to 3 months post-intervention
measure: Change in sexual distress
timeFrame: Baseline to 3 months post-intervention
Secondary outcomes:
measure: Change in relationship quality
timeFrame: Baseline to 3 months post-intervention
measure: Change in relationship Intimacy
timeFrame: Baseline to 3 months post-intervention
measure: Change in sexual function (female)
timeFrame: Baseline to 3 months post-intervention.
measure: Chang in sexual function (male)
timeFrame: Baseline to 3 months post-intervention
measure: Change in global sexual satisfaction
timeFrame: Baseline to 3 months post-intervention
measure: Change in depressive symptoms
timeFrame: Baseline to 3 months post-intervention
measure: Change in global health-related quality of life
timeFrame: Baseline to 3 months post-intervention
measure: Change in self-efficacy to communicate about sex and intimacy (survivor only)
timeFrame: Baseline to 3 months post-intervention
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Jessica R Gorman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gorman JR, Lyons KS, Harvey SM, Acquati C, Salsman JM, Kashy DA, Drizin JH, Smith E, Flexner LM, Hayes-Lattin B, Reese JB. Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples. Trials. 2022 Sep 2;23(1):730. doi: 10.1186/s13063-022-06665-3.