Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners - NCT00483678-19111 (Clinical Trial 171626)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy171626.aspx
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| City: |
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19111 |
| 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: A couples therapy program may enhance intimacy and reduce psychological distress
in patients with prostate cancer and in their partners.
PURPOSE: This randomized clinical trial is studying how well couples therapy enhances
intimacy and reduces psychological distress in patients with advanced or recurrent prostate
cancer and in their partners.
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| Study summary: |
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OBJECTIVES:
- Determine the feasibility of Intimacy-Enhancing Couples Therapy (IECT) for patients
with advanced or recurrent prostate cancer and their partners.
- Compare the effect of IECT vs usual care on patients' and their partners' level of
global psychological distress.
- Compare the effect of IECT vs usual care on relationship intimacy in these
participants.
OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are stratified
according to marital distress based on partners' scores on the Abbreviated Dyadic Adjustment
Scale (high [< 21] vs low [≥ 21]). Patients and their partners are randomized to 1 of 2
arms.
- Arm I: Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6
weeks comprising the following four 90-minute sessions: the Story of Cancer;
Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping,
Support, and Adaptation. Patients and their partners complete treatment satisfaction
questionnaires after completion of study intervention.
- Arm II: Patients and their partners receive standard psychosocial care. All
participants complete questionnaires assessing psychological distress, intimacy,
communication patterns, and overall relationship adjustment/satisfaction at baseline
and at 1 month after completion of study intervention.
PROJECTED ACCRUAL: A total of 76 couples will be accrued for this study. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Diagnosis of primary prostate cancer
- Advanced or recurrent disease
- Receiving concurrent hormonal therapy
- Married and/or co-habitating with a partner for ≥ 1 year
- T-score > 50 on Brief Symptom Inventory-18 questionnaire (patient and/or partner)
PATIENT CHARACTERISTICS:
- Normal cognitive functioning
- Able to speak and read English
- No significant 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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Fox Chase Cancer Center - Cheltenham
Philadelphia, PA 19111
United States
Primary Contact:
Sharon Manne, PhD
Email: sharon.manne@fccc.edu
Phone: 215-728-5523 |
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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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