Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners
This trial is active, not recruiting.
|Conditions||prostate cancer, psychosocial effects of cancer and its treatment, sexual dysfunction, sexuality and reproductive issues|
|Treatments||counseling intervention, questionnaire administration, psychosocial assessment and care|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||April 2007|
|End date||April 2017|
|Trial size||64 participants|
|Trial identifier||NCT00483678, 07-043, MSKCC-07043, P30CA008748|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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
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
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
Male or female participants from 18 years up to 120 years old.
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
|Official title||A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners|
|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.|
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