Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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||Phase|
|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||Not Applicable|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|