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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist young adult cancer survivors and their partners in addressing reproductive and sexual health issues resulting from cancer and its treatment. It tests two programs, "Opening the Conversation" and "Side by Side," which are designed to enhance communication and coping skills through a series of online sessions. The goal is to improve mental health and quality of life for those facing these often-overlooked challenges. Ideal participants are young adults diagnosed with breast or gynecologic cancer within the past 6 months to 5 years, who have a committed partner willing to join the sessions. Participants also need internet access and a device for videoconferencing. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could enhance support for cancer survivors and their partners.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on communication and coping strategies for cancer-related reproductive concerns.

What prior data suggests that this intervention is safe for young adult cancer survivors?

Research has shown that "Opening the Conversation" is a safe and well-received program. Studies have found that it helps young adult cancer survivors and their partners discuss difficult topics like reproductive and sexual health. The program focuses on teaching skills and providing education through online video sessions. No reports of serious side effects or negative outcomes have emerged from these sessions. This indicates the program's safety, as it primarily involves talking and learning in a supportive environment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Opening the Conversation" programs because they address cancer-related reproductive and sexual health concerns through a unique approach. Unlike traditional treatments that often focus on medical or pharmaceutical interventions, these programs offer education and skills training via videoconference, allowing for a more personalized and accessible experience. This method empowers participants to actively engage in their own care, fostering better communication and understanding of their health concerns. By focusing on communication and education, these programs aim to improve quality of life for cancer patients facing reproductive and sexual health issues.

What evidence suggests that this trial's interventions could be effective for addressing cancer-related reproductive concerns?

Research has shown that the "Opening the Conversation" program, available to participants in this trial, helps young couples manage reproductive and sexual health issues related to cancer. Many young adult cancer survivors encounter significant challenges in their sex lives and reproductive health due to cancer and its treatments. Over 60% of patients have reported negative impacts on their sex lives from cancer. The program aims to improve communication about these concerns, potentially reducing distress and enhancing mental health. Early findings suggest that addressing these issues can improve the quality of life for both survivors and their partners. Another program in this trial, "Side by Side," also focuses on education and skills training to address cancer-related concerns. ^{1 2 3 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9438271/

Opening the Conversation: study protocol for a Phase III ... This study evaluates the efficacy of a virtual couple-based intervention called Opening the Conversation (OC).

2. health.oregonstate.edu health.oregonstate.edu/research/tact/research/oc

Opening the Conversation | Research We have conducted several studies to explore the reproductive and sexual health concerns of young adult cancer survivors and how these issues affect their ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36056413/

study protocol for a Phase III trial to evaluate a couple- ... Secondary outcomes include communication about reproductive concerns, communication about sexual concerns, depressive symptoms, sexual function, ...

4. researchgate.net researchgate.net/publication/363233081_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_survivo

study protocol for a Phase III trial to evaluate a couple- ... This randomized controlled trial will determine the efficacy of a novel couple-based intervention to reduce distress related to RSH concerns for younger couples ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e24176

Exploring the reproductive and sexual health concerns of ... 60% of patients said cancer affected their sex life, with over 80% of those stating it was a net negative effect. 82% of patients had questions ...

6. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33595

We have to talk about it: Bringing fertility into the conversation ... Other studies have noted similarly high numbers of women for whom fertility is a concern. Partridge et al found that 57% of young breast cancer ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11489118/

Addressing sexual health in oncology: perspectives and ... At least 40% of cancer patients experience alterations at the sexual level as a consequence of chemotherapy, radiotherapy, hormone therapy and ...