Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

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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Aim 1 A. To evaluate the impact of an Intimacy-Enhancing Couples' intervention (IEC) versus a General Health and Wellness Intervention (GHW) and a Usual care control (UC) on patient and partner psychological and relationship outcomes. B. To determine whether relationship length, pre-intervention relationship satisfaction, and men's pre-intervention masculinity moderate the effects of IEC on couples' psychological and relationship outcomes Aim 2 A. To evaluate whether IEC has an effect on couples' communication and intimacy when compared with GHW and UC and to determine whether changes in relationship communication and intimacy mediate changes in couples' psychological and relationship outcomes. Exploratory Aim: A. To evaluate the impact of IEC versus GHW on physical activity and fruit and vegetable intake as well as each partner's support for the other partner's adoption of greater physical activity and more fruit and vegetable intake.

Official Title
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Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

Conditions
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Prostate Cancer, Sexual Dysfunction and Infertility, Sexuality

Intervention / Treatment
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* Other: communication intervention
* Other: counseling intervention
* Other: nutrition intervention
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a primary diagnosis of localized prostate cancer (T1, T2, N=0 M=0, T3 N=0 M=0) Patient had surgery or initiated radiation treatment (brachytherapy or external beam radiation) or began pre-radiation Androgen deprivation therapy within the past 12 months. Patient is currently married or living with a partner, with relationship duration at least 1 year Patient and partner live within a 1 hour commuting distance to recruitment site Patient and partner read and speak English Patient has an Impact of Events Scale (IES) score greater than or equal to 16 and/or partner has an IES score greater than or equal to 17. Exclusion Criteria: Patient had a previous definitive treatment for prostate cancer Patient has a concurrent diagnosis of another cancer (other than non-melanoma skin cancer) Partner is diagnosed with cancer (other than non-melanoma skin cancer) Patient or partner have a significant hearing impairment

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

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intimacy-Enhancing Couples<br>Patients and their partners receive communication and intimacy-enhancing intervention (IEC) once a week comprising the following five 90-minute sessions: Orientation and Stories of the Cancer Experience; Communication and Listening to Partner's concerns; Communication and Coping with Cancer Issues as a Team; Being Supportive to Solve Concerns; and Reflecting on Changes and Future Adaptation. | Other: communication intervention<br> <br> Other: counseling intervention<br> <br> Other: questionnaire administration<br> <br> |
| Active Comparator: General Health and Wellness<br>Patients and their partners receive a General Health and Wellness intervention focusing on nutrition and physical activity once a week comprising of five 90-minute sessions: Introduction and Nutrition Basics; Nutrition and Prevention of Recurrence; Nutritional Review and Introduction to Relaxation; Physical Activity Basics; Aerobics and Resistance Exercises and Wrap up. | Other: counseling intervention<br> <br> Other: nutrition intervention<br> <br> Other: questionnaire administration<br> <br> |
| Other: Usual Care<br>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). | Other: questionnaire administration<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Functioning | General psychological functioning is assessed by the MHI-38 and the PHQ-9. Cancer-Specific distress is assessed by using the Impact of Events Scale Revised Cancer-Specific concerns is assessed with a 10 item assessment of commonly-experienced problems. | 5 years | 
| Relationship Functioning | Relationship satisfaction is assessed using the Dyadic Adjustment Scale | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intimacy | General Relationship Intimacy. The Personal Assessment of Intimacy in Relationships Intimacy scale (PAIR) (94) is a 6 item scale assessing emotional closeness. Cancer-specific Relationship Intimacy (95-96) Participants rate the degree to which they felt close to and emotionally intimate with their partner during discussions about the cancer experience. | 5 years | 
| Relationship Communication | Perceived self-disclosure. The scale assesses the degree to which they disclose thoughts, information, and feelings about the cancer experience in the past week. Perceived partner disclosure. The scale assesses the degree to which their partner disclosed thoughts, information, and feelings. Perceived partner responsiveness. The scale assesses the degree to which the participant felt their partner understood and empathized with their disclosures.Mutual Constructive Communication. This subscale of the Communication Pattern Questionnaire (CPQ) is a 5-item scale that has been adapted. Holding back. Participants rate the degree to which they held back from talking to their partner about 11 domains of concern. Demand-Withdraw. The CPQ Demand-Withdraw subscale is a 6-item scale adapted. Mutual Avoidance. The CPQ Mutual Avoidance subscale is an adapted 6-item scale. | 5 years |