Clinical trial · Interventional
Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
- 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 central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial. We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral, Psychological or Informational Intervention | Behavioral | — | UNRESOLVED |
| Intimacy Enhancing Intervention | Behavioral | — | UNRESOLVED |
| Living Healthy Together | Behavioral | — | UNRESOLVED |
| Partner-Assisted Coping Skills Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intimacy Enhancing Intervention
- description
- Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.
- interventionNames
- Behavioral: Intimacy Enhancing Intervention
- Behavioral: Partner-Assisted Coping Skills Training
- type
- ACTIVE_COMPARATOR
- label
- Living Healthy Together
- description
- Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female 2. Age \> 21 years 3. Has diagnosis of non-recurrent stage I-III breast cancer 4. Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable) 5. Has a partner or spouse who is \> 21 6. Lives with a romantic partner \> 6 months 7. Score of \> 3 on Patient Care Monitor Sexual Concerns screening item 8. No hearing impairment in patient or partner Exclusion Criteria: 1. Not able to speak English, as stated in medical record or as observed by study team member 2. ECOG Performance score \> 2 OR too ill to participate as judged by physician/in medical record 3. Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer. 4. Past history of any cancer other than non-melanoma skin cancer 5. Currently participating in couple/marital therapy 6. Currently pregnant
References
Publications (0)
Data not yet available