Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners

March 5, 2018 updated by: Memorial Sloan Kettering Cancer Center

A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners

RATIONALE: A couples therapy program may enhance intimacy and reduce psychological distress in patients with prostate cancer and in their partners.

PURPOSE: This randomized clinical trial is studying how well couples therapy enhances intimacy and reduces psychological distress in patients with advanced or recurrent prostate cancer and in their partners.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the feasibility of Intimacy-Enhancing Couples Therapy (IECT) for patients with advanced or recurrent prostate cancer and their partners.
  • Compare the effect of IECT vs usual care on patients' and their partners' level of global psychological distress.
  • Compare the effect of IECT vs usual care on relationship intimacy in these participants.

OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are stratified according to marital distress based on partners' scores on the Abbreviated Dyadic Adjustment Scale (high [< 21] vs low [≥ 21]). Patients and their partners are randomized to 1 of 2 arms.

  • Arm I: Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions: the Story of Cancer; Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping, Support, and Adaptation. Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention.
  • Arm II: Patients and their partners receive standard psychosocial care. All participants complete questionnaires assessing psychological distress, intimacy, communication patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month after completion of study intervention.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Cheltenham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of primary prostate cancer

    • Advanced or recurrent disease
  • Receiving concurrent hormonal therapy
  • Married and/or co-habitating with a partner for ≥ 1 year
  • T-score > 50 on Brief Symptom Inventory-18 questionnaire (patient and/or partner)

PATIENT CHARACTERISTICS:

  • Normal cognitive functioning
  • Able to speak and read English
  • No significant hearing impairment that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intimacy-Enhancing Couples Therapy
Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions: the Story of Cancer; Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping, Support, and Adaptation. Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention.
Other: questionnaire administration
Procedure: psychosocial assessment and care
Other: counseling intervention
Active Comparator: standard psychosocial care
Patients and their partners receive standard psychosocial care. All participants complete questionnaires assessing psychological distress, intimacy, communication patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month after completion of study intervention
Other: questionnaire administration
Procedure: psychosocial assessment and care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of Intimacy-Enhancing Couples Therapy (IECT) (e.g., eligibility rate, acceptance rate, attendance rate, satisfaction) assessed at baseline and at 1 month after completion of study intervention
Time Frame: 2 years
2 years
Comparison of the preliminary effect of IECT vs usual care on global psychological distress and relationship intimacy as assessed by the BSI-18 at baseline and at 1 month after completion of study intervention
Time Frame: 2 years
2 years
Relationship functioning, including intimacy, communication, and satisfaction (cancer-specific and overall) as assessed by the CRCS and A-DAS at baseline and at 1 month after completion of study intervention
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)
Fox Chase Cancer Center

Investigators

  • Study Chair: Talia Zaider, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

June 6, 2007

First Submitted That Met QC Criteria

June 6, 2007

First Posted (Estimate)

June 7, 2007

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-043
  • P30CA008748 (U.S. NIH Grant/Contract)
  • MSKCC-07043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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