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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00503646

Collaborator

National Cancer Institute (NCI) (NIH)

100

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 1, 2007

Anticipated Primary Completion Date :

May 1, 2010

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10022
2	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center
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