Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners - NCT00503646-10022 (Clinical Trial 177799)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy177799.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10022 |
| Conditions: |
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Prostate Cancer - Psychosocial Effects of Cancer and Its Treatment - Sexual Dysfunction and Infertility - Sexuality and Reproductive Issues |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Patient has a primary diagnosis of localized (early stage) prostate cancer
- Has undergone surgery within the past year
- Patient and partner married or cohabiting and relationship duration ≥ 1 year
PATIENT CHARACTERISTICS:
- ECOG performance status 0 or 1 at the time of initial recruitment
- Lives within 2-hour commuting distance from recruitment center (MSKCC or FCCC)
- No significant self-identified hearing impairment that would preclude study
participation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics |
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| Study is available at: |
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Memorial Sloan-Kettering Cancer Center
New York, NY 10022
United States
Primary Contact:
Christian J. Nelson, PhD
Email: nelsonc@mskcc.org
Phone: 646-888-0030 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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