Skip to main content
Clinical Trials/NCT00503646
NCT00503646
Unknown
Not Applicable

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

Memorial Sloan Kettering Cancer Center2 sites in 1 country100 target enrollmentMay 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
100
Locations
2
Primary Endpoint
Feasibility and acceptability
Last Updated
12 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
May 2010
Last Updated
12 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Feasibility and acceptability

Descriptive characteristics of study measures

Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy

Study Sites (2)

Loading locations...

Similar Trials