Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners

Study Overview
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Brief Summary
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RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners. PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.

Detailed Description
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OBJECTIVES: Primary To evaluate the feasibility and acceptability of conducting a randomized clinical trial evaluating communication and intimacy-enhancing intervention (CI) vs usual care (UC). To collect descriptive information and basic psychometrics on proposed study measures. To gather preliminary data regarding the impact of CI on couples' psychosocial adaptation, relationship closeness, and sexual intimacy in order to calculate power for a larger full scale trial. OUTLINE: This is a multicenter study. Patients and their partners are randomized to 1 of 2 intervention arms. Arm I: Patients and their partners receive communication and intimacy-enhancing intervention (CI) once a week comprising the following five 90-minute sessions: Rationale and Overview; Basic Communication; Intimacy and Sexuality; Improving Intimacy; and Reflecting on Changes and Cancer Survivorship. Arm II: Patients and their partners receive standard psychological and emotional care (usual care [UC]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician). Physical impairment, psychological adjustment, relationship closeness, relationship communication, sexual function and satisfaction, male self-esteem, relationship satisfaction, intervention evaluation, and erectile dysfunction treatment utilization, and referral are assessed at 1 week post-intervention or at 6-8 weeks post baseline and then at 3 months (for patients and their partners in arm I) and at 8 weeks post-baseline and then at 3 months (for patients and their partners in arm II). PROJECTED ACCRUAL: A total of 50 patients and 50 partners will be accrued for this study.

Official Title
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Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial

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

Intervention / Treatment
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* Other: communication intervention
* 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: Patient has a primary diagnosis of localized (early stage) prostate cancer Has undergone surgery within the past year Patient and partner married or cohabiting and relationship duration ≥ 1 year PATIENT CHARACTERISTICS: ECOG performance status 0 or 1 at the time of initial recruitment Lives within 2-hour commuting distance from recruitment center (MSKCC or FCCC) No significant self-identified 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

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

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: communication intervention|nan|
|Other: counseling intervention|nan|
|Other: questionnaire administration|nan|
|Procedure: psychosocial assessment and care|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability |  |  | 
| Descriptive characteristics of study measures |  |  | 
| Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy |  |  | 

 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 and infertility, sexuality and reproductive issues, stage IIB prostate cancer, stage IIA prostate cancer, stage I prostate cancer