Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
Fox Chase Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00483678
First received: June 6, 2007
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Sexual Dysfunction Sexuality and Reproductive Issues |
Other: counseling intervention Other: questionnaire administration Procedure: psychosocial assessment and care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- Feasibility of Intimacy-Enhancing Couples Therapy (IECT) (e.g., eligibility rate, acceptance rate, attendance rate, satisfaction) assessed at baseline and at 1 month after completion of study intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Comparison of the preliminary effect of IECT vs usual care on global psychological distress and relationship intimacy as assessed by the BSI-18 at baseline and at 1 month after completion of study intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Relationship functioning, including intimacy, communication, and satisfaction (cancer-specific and overall) as assessed by the CRCS and A-DAS at baseline and at 1 month after completion of study intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 64 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intimacy-Enhancing Couples Therapy
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.
|
Other: counseling intervention Other: questionnaire administration Procedure: psychosocial assessment and care |
|
Active Comparator: standard psychosocial care
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
|
Other: questionnaire administration Procedure: psychosocial assessment and care |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483678
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center - Cheltenham | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Fox Chase Cancer Center
Investigators
| Study Chair: | Talia Zaider, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00483678 History of Changes |
| Other Study ID Numbers: | 07-043, P30CA008748, MSKCC-07043 |
| Study First Received: | June 6, 2007 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
psychosocial effects of cancer and its treatment sexual dysfunction sexuality and reproductive issues |
recurrent prostate cancer stage III prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Sexual Dysfunctions, Psychological Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013