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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00483678

Collaborator

National Cancer Institute (NCI) (NIH), Fox Chase Cancer Center (Other)

Enrollment

Locations

Arms

131

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
2	Fox Chase Cancer Center - Cheltenham	Philadelphia	Pennsylvania	United States	19111-2497