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

Prostate Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized

Related Conditions & MeSH terms

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

• NCT number: NCT00503646
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Recruiting
• Phase: N/A
• Start date: May 2007