Clinical trial · Interventional
Coping Together After Breast Cancer
Addressing Sexual Concerns in Breast Cancer Survivors: Randomized Controlled Trial of a Novel Couple-Based Intervention
- 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)
The objective of the proposed study is to evaluate an Intimacy Enhancement (IE) intervention in 120 female early stage breast cancer survivors reporting sexual concerns and their intimate partners (240 total participants). Couples will be randomized 1:1 to receive either the IE intervention or to an information and support condition (Living Healthy Together). The investigators will evaluate intervention effects on patient and partner sexual, relationship, and psychological outcomes.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intimacy Enhancement | Behavioral | — | UNRESOLVED |
| Living Healthy Together | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intimacy Enhancement
- description
- Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
- interventionNames
- Behavioral: Intimacy Enhancement
- type
- ACTIVE_COMPARATOR
- label
- Living Healthy Together
- description
- Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.
- interventionNames
- Behavioral: Living Healthy Together
Primary outcomes (1)
- measure
- Change in Self-Reported Patient Sexual Function
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is female * Patient age 18 years or older * Patient has a medically confirmed diagnosis of non-recurrent breast cancer (Stages T1-T4, N0-N1, M0) * Patient completed active treatment (e.g., chemotherapy, radiation therapy, surgery, immunotherapy) 6 months-5 years ago (current use of endocrine therapy is acceptable) * Patient is currently in a partnered relationship that could involve sexual activity * Partner or spouse is 18 years or older * Patient lives with a romantic partner for at least 6 months * Patient has a score of at least 3 on Patient Care Monitor Sexual Concerns screening item Exclusion Criteria: * Patient or partner is not able to speak and read English, as stated in medical record, as observed by study team member or in self-report * Patient or partner ECOG Performance score \> 2 OR medically unable to participate as judged by physician/in medical record or by self-report * Patient or partner has a hearing impairment * Patient and partner do not have reliable telephone access * Patient has overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, physician or referring source, or self-report * Patient past or current history of any cancer other than non-melanoma skin cancer, including prior breast cancer * Patient is currently participating in couple/marital therapy * Patient is currently pregnant
References
Publications (1)
- DERIVEDReese JB, Zimmaro LA, Lepore SJ, Sorice KA, Handorf E, Daly MB, Schover LR, Kashy D, Westbrook K, Porter LS. Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial. Trials. 2020 Feb 12;21(1):173. doi: 10.1186/s13063-019-3975-2. PMID 32051002