Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners

September 16, 2013 updated by: Memorial Sloan Kettering Cancer Center

Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial

RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners.

PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the feasibility and acceptability of conducting a randomized clinical trial evaluating communication and intimacy-enhancing intervention (CI) vs usual care (UC).
  • To collect descriptive information and basic psychometrics on proposed study measures.
  • To gather preliminary data regarding the impact of CI on couples' psychosocial adaptation, relationship closeness, and sexual intimacy in order to calculate power for a larger full scale trial.

OUTLINE: This is a multicenter study. Patients and their partners are randomized to 1 of 2 intervention arms.

  • Arm I: Patients and their partners receive communication and intimacy-enhancing intervention (CI) once a week comprising the following five 90-minute sessions: Rationale and Overview; Basic Communication; Intimacy and Sexuality; Improving Intimacy; and Reflecting on Changes and Cancer Survivorship.
  • Arm II: Patients and their partners receive standard psychological and emotional care (usual care [UC]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician).

Physical impairment, psychological adjustment, relationship closeness, relationship communication, sexual function and satisfaction, male self-esteem, relationship satisfaction, intervention evaluation, and erectile dysfunction treatment utilization, and referral are assessed at 1 week post-intervention or at 6-8 weeks post baseline and then at 3 months (for patients and their partners in arm I) and at 8 weeks post-baseline and then at 3 months (for patients and their partners in arm II).

PROJECTED ACCRUAL: A total of 50 patients and 50 partners will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

100

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, 10022
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Recruiting
        • Fox Chase Cancer Center - Philadelphia

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Patient has a primary diagnosis of localized (early stage) prostate cancer

    • Has undergone surgery within the past year
  • Patient and partner married or cohabiting and relationship duration ≥ 1 year

PATIENT CHARACTERISTICS:

  • ECOG performance status 0 or 1 at the time of initial recruitment
  • Lives within 2-hour commuting distance from recruitment center (MSKCC or FCCC)
  • No significant self-identified 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

  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Feasibility and acceptability
Descriptive characteristics of study measures
Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy

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)

Investigators

  • Principal Investigator: David W. Kissane, MD, Memorial Sloan Kettering Cancer Center
  • Principal Investigator: Christian J. Nelson, 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.

General Publications

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

May 1, 2007

Primary Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-069
  • MSKCC-07069

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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