Communication Intervention for Cancer-Related Reproductive Concerns

Overseen By Jessica R Gorman, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon State University

Disqualifiers: Non-English speaking, No internet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 5-7.5 hours total

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jessica R Gorman, PhD, MPH

Principal Investigator

Oregon State University

Are You a Good Fit for This Trial?

This trial is for young adult survivors of breast or gynecologic cancer, aged 18-44, who were diagnosed between ages 18-39 and are within 6 months to 5 years post-diagnosis. Participants must have a committed partner over the age of 18 willing to join, speak English, and have high-speed internet for videoconferencing.

Inclusion Criteria

Partner participants:

High speed internet access via smart phone, tablet and/or computer

English speaking

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Systematically adapt an empirically supported couple-based skills training intervention for young breast and gynecologic cancer survivors and their partners

Not specified

Treatment

Participants attend 4-5 sessions (1.5 hours each) consisting of education and skills training to address cancer-related reproductive and sexual health concerns via videoconference

5-7.5 hours total

4-5 visits (virtual)

Follow-up

Participants are monitored for changes in sexual function, depressive symptoms, global health-related quality of life, self-efficacy to communicate about sex and intimacy, relationship quality, intimacy, and sexual satisfaction

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Opening the Conversation
• Side by Side

Trial Overview The 'Opening the Conversation' study tests an intervention aimed at helping young couples cope with reproductive and sexual health issues after cancer. It involves adapting an evidence-based program for these survivors and their partners to improve communication on these sensitive topics.

How Is the Trial Designed?

Group I: Program #1 Experimental Treatment 1 Intervention

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.

Group II: Program #2 Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Oregon State University

Lead Sponsor

Trials

51

Recruited

8,300+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+