Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction, Sexuality and Reproductive Issues
Conditions
Keywords
psychosocial effects of cancer and its treatment, sexual dysfunction, sexuality and reproductive issues, recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer
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.
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.
Interventions
OTHERcounseling intervention
OTHERquestionnaire administration
PROCEDUREpsychosocial assessment and care
Sponsors
National Cancer Institute (NCI)
Fox Chase Cancer Center
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed