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An Intimacy Intervention for Couples Completing Breast or Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04221607
Recruitment Status : Completed
First Posted : January 9, 2020
Last Update Posted : April 8, 2021
Keitner/Family Therapy Research Grant
Information provided by (Responsible Party):
Don Dizon, Brown University

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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction Breast Cancer Prostate Cancer Other: Sensate Focus exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility of intervention
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Intimacy Intervention for Couples Completing Breast or Prostate Cancer
Actual Study Start Date : December 9, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Feasibility
Sensate Focus Exercises aim to help couples be more present with one another through talking and through touch.
Other: Sensate Focus exercise
Structured exercise to enhance intimacy

Primary Outcome Measures :
  1. Phase one: Feasibility [ Time Frame: Four weeks ]
    Proportion of couples enrolled in phase one who are practicing sensate focus at 4 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04221607

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United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02382
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Keitner/Family Therapy Research Grant
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Principal Investigator: Don S Dizon, MD Rhode Island Hospital
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Responsible Party: Don Dizon, Professor of Medicine, Brown University Identifier: NCT04221607    
Other Study ID Numbers: 1413727
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Don Dizon, Brown University:
sensate focus
breast cancer
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases