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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Start Date
May 1, 2007
Primary Completion Date
May 1, 2010
Last Updated
September 17, 2013
100
ESTIMATED participants
communication intervention
OTHER
counseling intervention
OTHER
questionnaire administration
OTHER
psychosocial assessment and care
PROCEDURE
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT05691465
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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