Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners
|ClinicalTrials.gov Identifier: NCT00503646|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : July 19, 2007
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Sexual Dysfunction and Infertility Sexuality and Reproductive Issues||Other: communication intervention Other: counseling intervention Other: questionnaire administration Procedure: psychosocial assessment and care|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Official Title:||Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||May 2010|
- Feasibility and acceptability
- Descriptive characteristics of study measures
- Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503646
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10022|
|Contact: Christian J. Nelson, PhD 646-888-0030 email@example.com|
|United States, Pennsylvania|
|Fox Chase Cancer Center - Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790|
|Principal Investigator:||David W. Kissane, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Christian J. Nelson, PhD||Memorial Sloan Kettering Cancer Center|