Clinical trial · Interventional
An Intimacy Intervention for Couples Completing Breast or Prostate 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)
This project seeks to help patients address and improve intimacy at the end of treatment for breast or prostate cancer. It is intended to address the needs of cancer survivors, broadly defined as paftients and their loved ones or caregivers facing a cancer diagnosis. While we know sexual health is impacted by the diagnosis and treatments for cancer, we also are increasingly aware that partners and spouses are also impacted by the experience. Yet, there are no evidence based interventions that focus on the couple's recovery after the initial cancer experience. The objective of this study is to look at the impact of an intimacy intervention at the completion of cancer treatment for couples facing breast or prostate cancer. We will enroll patients and their intimate partners in this study in two phases. In the first phase, couples will receive sensate focus homework, explained to them at a standard survivorship care visit (SCV) by a study nurse practitioner (NP). The objective in the first phase is to see if this is something feasible by looking at how many use sensate focus homework in 6 weeks. If it is not feasible, we will rework the study based on what we learned. However, if it is feasible, we will reopen the study to a larger group and employ a random assignment to an SCV with or without sensate focus homework. This phase will give us evidence of efficacy that we will use to propose a larger randomized trial, potentially in the National Cancer Institute system. Participants will be asked to answer questionnaires at baseline, 6 weeks, and then at 12 weeks during phase 2. Those who complete treatment at 12 weeks will be re-contacted 6 months after protocol enrollment for an optional end of treatment interview to assess what they thought of the intervention, including sensate focus homework itself and the timing.
Conditions
Conditions (3)
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 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sensate Focus exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Feasibility
- description
- Sensate Focus Exercises aim to help couples be more present with one another through talking and through touch.
- interventionNames
- Other: Sensate Focus exercise
Primary outcomes (1)
- measure
- Phase one: Feasibility
- timeFrame
- Four weeks
- description
- Proportion of couples enrolled in phase one who are practicing sensate focus at 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (≥18 years) with histologically proven breast or prostate cancer * Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member. * Completed curative intent treatment for cancer no more than 6 months prior to study enrollment. Treatment may have consisted of surgery, chemotherapy, and/or radiation therapy. Patients on extended adjuvant (maintenance) treatment will be allowed to enroll. * In a stable non-married relationship or otherwise partnered or married. * Partner willing to participate in study Exclusion Criteria: * history of significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits the patient's ability to participate in the informed consent procedures
References
Publications (0)
Data not yet available