Clinical trial · Interventional
Opening the Conversation Study
Opening the Conversation for Couples With Reproductive Health Concerns
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Opening the Conversation | Behavioral | — | UNRESOLVED |
| Side by Side | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Program #1
- 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.
- interventionNames
- Behavioral: Opening the Conversation
- type
- ACTIVE_COMPARATOR
- label
- Program #2
- description
- Participants attend 4 sessions (1.5 hours each) consisting of education and skills training to address cancer-related concerns. Sessions occur via videoconference.
- interventionNames
- Behavioral: Side by Side
Primary outcomes (2)
- measure
- Change in reproductive distress
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDGorman JR, Choun S, Lyons KS, Acquati C, Harvey SM, Salsman JM, Flexner L, Koneru G, Hayes-Lattin B, Reese JB. Dyadic Latent Profiles of Sexual and Reproductive Distress in Young Adult Cancer Survivors and Their Partners: A Cross-Sectional Analysis. Psychooncology. 2026 Aug;35(8):e70587. doi: 10.1002/pon.70587. PMID 42635443
- DERIVEDGorman 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. PMID 36056413