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NCT04221607 · ClinicalTrials.gov registry record · NA
An Intimacy Intervention for Couples Completing Breast or Prostate Cancer
A NA study, sponsored by Brown University.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT04221607: Completed NA study, sponsored by Brown University.
NCT04221607 is a NA study that has completed, run by Brown University. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04221607, a NA study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Proportion of couples enrolled in phase one who are practicing sensate focus at 4 weeks
Interventions
- OTHER Sensate Focus exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-12-09 |
| Est. Completion | 2020-12-31 |
| Phase | NA |
What the finished NCT04221607 record still lists
NCT04221607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Sensate Focus exercise is the first listed.
NCT04221607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04221607 about?
NCT04221607 is a clinical study titled "An Intimacy Intervention for Couples Completing Breast or Prostate Cancer". 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 i...
What is the current status of trial NCT04221607?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2019-12-09. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT04221607?
The interventions under investigation include: Sensate Focus exercise (OTHER).
Who is sponsoring clinical trial NCT04221607?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04221607's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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