Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners

Conditions
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Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction, Sexuality and Reproductive Issues

Intervention / Treatment
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* Other: counseling intervention
* Other: questionnaire administration
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intimacy-Enhancing Couples Therapy<br>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<br> <br> Other: questionnaire administration<br> <br> Procedure: psychosocial assessment and care<br> <br> |
| Active Comparator: standard psychosocial care<br>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<br> <br> Procedure: psychosocial assessment and care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 2 years | 
| 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 |  | 2 years | 
| 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 |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, sexual dysfunction, sexuality and reproductive issues, recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer