NCT00503646

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

Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Prostate Cancer
• Psychosocial Effects of Cancer and Its Treatment
• Sexual Dysfunction and Infertility
• Sexuality and Reproductive Issues

Interventions

Type	Name	Description
OTHER	communication intervention
OTHER	counseling intervention
OTHER	questionnaire administration
PROCEDURE	psychosocial assessment and care

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-05-01
• First posted: 2007-07-19
• Last updated: 2013-09-17

Locations

2 sites across 1 country: United States