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An Intimacy Intervention for Couples Completing Breast or Prostate Cancer

Primary Purpose

Sexual Dysfunction, Breast Cancer, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensate Focus exercise
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sexual Dysfunction focused on measuring intimacy, sensate focus, survivorship, breast cancer, prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island Hospital
  • The Miriam Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feasibility

Arm Description

Sensate Focus Exercises aim to help couples be more present with one another through talking and through touch.

Outcomes

Primary Outcome Measures

Phase one: Feasibility
Proportion of couples enrolled in phase one who are practicing sensate focus at 4 weeks

Secondary Outcome Measures

Full Information

First Posted
January 4, 2020
Last Updated
April 5, 2021
Sponsor
Brown University
Collaborators
Keitner/Family Therapy Research Grant
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1. Study Identification

Unique Protocol Identification Number
NCT04221607
Brief Title
An Intimacy Intervention for Couples Completing Breast or Prostate Cancer
Official Title
An Intimacy Intervention for Couples Completing Breast or Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
Keitner/Family Therapy Research Grant

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The National Comprehensive Cancer Network (NCCN) identifies sexual dysfunction as a major issue facing cancer survivors (defined broadly as patients and their caregivers, starting at the point of the index cancer diagnosis). It is well known that a cancer diagnosis and treatment negatively impacts partner relationships and quality of life (QOL) (for both patient and partner). Despite this, only about a third of patients seek assistance, and the figures regarding assistance from caregivers is lacking. The etiology of sexual dysfunction is multifactorial and includes problems with sexual desire and pleasure, hormonal deficiencies, vaginal and penile alterations related to treatment, delayed or absent orgasm and/or ejaculation, pain with intercourse, erectile dysfunction, and psychological problems such as anxiety, depression, and changes in body-image. Unfortunately, interventions have largely focused on ways to improve sexual function, although even these are limited. Additionally, clinicians are often reluctant to address sexual function with their patients due to their lack of training and discomfort in engaging in these conversations. Given the well-documented burden of sexual dysfunction, there is a compelling need to develop interventions to address sexual health, for both patient and partner while encouraging clinicians to discuss sexual health issues. Beyond the issues of the individual, couples and families are also impacted by cancer treatment. A wide body of literature shows that a cancer experience can add additional demands on couples, especially in the realms of communication, intimacy, and sexuality. A small study of 8 couples where the female partner had breast cancer identified three themes of significance: (1) disconnection from the relationship, due to the woman prioritizing her own needs before those of the partner or of them as a couple; (2) renegotiation of the couple relationship; and (3) need for support for negotiating going forward as a couple. Unfortunately, they also comment on the limited evidence-based interventions to aide this transition, particularly for the couple. In this project, the investigators will build upon standard procedures to address intimacy at the end of curative intent therapy through sensate focusing exercises (SF). SF will be delivered during a face-to-face survivorship visit using a trial-specific script. The project will proceed in two phases. During phase 1, the investigators will assess feasibility by conducting a prospective pilot study. During phase 2, the investigators will conduct a randomized trial comparing survivorship care with or without sensate focusing. This project has the potential to substantially enhance the care of survivors. By implementing such an intervention to improve sexual function, we aim to enhance the QOL and intimacy of cancer survivors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Breast Cancer, Prostate Cancer
Keywords
intimacy, sensate focus, survivorship, breast cancer, prostate cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility of intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feasibility
Arm Type
Experimental
Arm Description
Sensate Focus Exercises aim to help couples be more present with one another through talking and through touch.
Intervention Type
Other
Intervention Name(s)
Sensate Focus exercise
Intervention Description
Structured exercise to enhance intimacy
Primary Outcome Measure Information:
Title
Phase one: Feasibility
Description
Proportion of couples enrolled in phase one who are practicing sensate focus at 4 weeks
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don S Dizon, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02382
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Intimacy Intervention for Couples Completing Breast or Prostate Cancer

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