Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

N/ACompletedNCT01982058

Rutgers, The State University of New Jersey483 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

483

Conditions

Prostate Cancer Sexual Dysfunction and Infertility Sexuality

Interventions

communication interventionOTHER

counseling interventionOTHER

nutrition interventionOTHER

questionnaire administrationOTHER

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

The University Hospital

Newark, New Jersey, United States

Garden State Urology

Whippany, New Jersey, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Relationship Functioning

Relationship satisfaction is assessed using the Dyadic Adjustment Scale

Time frame: 5 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 5 years

Data from ClinicalTrials.gov

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