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

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: NCT00503646
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : July 19, 2007
Last Update Posted : September 17, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Sexual Dysfunction and Infertility Sexuality and Reproductive Issues Other: communication intervention Other: counseling intervention Other: questionnaire administration Procedure: psychosocial assessment and care Not Applicable

Detailed Description:



  • 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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Official Title: Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial
Study Start Date : May 2007
Estimated Primary Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Feasibility and acceptability
  2. Descriptive characteristics of study measures
  3. Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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


  • 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


  • See Disease Characteristics

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): NCT00503646

United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10022
Contact: Christian J. Nelson, PhD    646-888-0030   
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi    215-728-4790      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: David W. Kissane, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Christian J. Nelson, PhD Memorial Sloan Kettering Cancer Center

Publications of Results: Identifier: NCT00503646     History of Changes
Other Study ID Numbers: 07-069
First Posted: July 19, 2007    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
psychosocial effects of cancer and its treatment
sexual dysfunction and infertility
sexuality and reproductive issues
stage IIB prostate cancer
stage IIA prostate cancer
stage I prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Genital Diseases, Female