Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Educational/Counseling/Training Active 18 and over NCI MSKCC-07069 07-069, NCT00503646

Objectives

Primary

1. To evaluate the feasibility and acceptability of conducting a randomized clinical trial evaluating communication and intimacy-enhancing intervention (CI) vs usual care (UC).
2. To collect descriptive information and basic psychometrics on proposed study measures.
3. 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.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics

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

Expected Enrollment

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

Outcomes

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

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).

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

David Kissane, MD, Principal investigator		Ph: 646-888-0019; 800-525-2225
Christian Nelson, PhD, Principal investigator		Ph: 646-888-0030; 800-525-2225 Email: nelsonc@mskcc.org

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Christian Nelson, PhD	Ph:  646-888-0030 800-525-2225
			Email: nelsonc@mskcc.org
Pennsylvania
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790

Registry Information
Official Title		Communication and Intimacy-Enhancing Intervention for Men Diagnosed with Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial
Trial Start Date		2007-05-22
Trial Completion Date		2010-05-24 (estimated)
Registered in ClinicalTrials.gov		NCT00503646
Date Submitted to PDQ		2007-06-14
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA08748

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