An Intimacy Intervention for Couples Completing Breast or Prostate Cancer

NCT04221607 | Completed

• 1 other identifier: 1413727
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Sexual Dysfunction; Breast Cancer; Prostate Cancer

Keywords

intimacy; sensate focus; survivorship; breast cancer; prostate cancer

Outcome Measures

Primary Outcomes (1)

• Phase one: Feasibility

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

  Four weeks

Study Arms (1)

Feasibility

EXPERIMENTAL

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

Other: Sensate Focus exercise

Interventions

Sensate Focus exercise OTHER

Structured exercise to enhance intimacy

Feasibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brown University: lead
• Keitner/Family Therapy Research Grant: collaborator

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02382, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Don S Dizon, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Feasibility of intervention

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 9, 2020
• Study Start: December 9, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)