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Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners - NCT00503646-19111(Clinical Trial 177800)



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City:  Philadelphia
State:  
PA
Zip Code: 19111
Conditions: Prostate Cancer - Psychosocial Effects of Cancer and Its Treatment - Sexual Dysfunction and Infertility - Sexuality
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.
Study summary: 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.
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
Study is available at: Fox Chase Cancer Center - Philadelphia
Philadelphia, PA 19111
United States

Primary Contact:
Clinical Trials Office - Fox Chase Cancer Center - Philadelphi
Phone: 215-728-4790
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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