An Intimacy Intervention for Couples Completing Breast or Prostate Cancer
Completed · Not applicable
Conditions studied: Sexual Dysfunction, Breast Cancer, Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT04221607
- Run by
- Brown University
- People needed
- 14
- Starts
- 2019-12-09
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2021-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rhode Island Hospital — Providence, Rhode Island, United States
- The Miriam Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.