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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00503646
First received: July 17, 2007
Last updated: September 16, 2013
Last verified: July 2009
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility and acceptability [ Designated as safety issue: No ]
  • Descriptive characteristics of study measures [ Designated as safety issue: No ]
  • Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2007
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503646

Locations
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    nelsonc@mskcc.org   
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
Investigators
Principal Investigator: David W. Kissane, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Christian J. Nelson, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00503646     History of Changes
Other Study ID Numbers: 07-069, MSKCC-07069
Study First Received: July 17, 2007
Last Updated: September 16, 2013
Health Authority: Unspecified

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:
Infertility
Prostatic Neoplasms
Sexual Dysfunctions, Psychological
Genital Diseases, Male
Genital Diseases, Female
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014