Prostate Cancer Clinical Trial

Intimacy-Enhancing Couples’ Intervention for Localized Prostate Cancer

Summary

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.

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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

483

Study ID:

NCT01982058

Recruitment Status:

Completed

Sponsor:

Rutgers, The State University of New Jersey

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There are 6 Locations for this study

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Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
The University Hospital
Newark New Jersey, 07103, United States
Garden State Urology
Whippany New Jersey, 07981, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10022, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

483

Study ID:

NCT01982058

Recruitment Status:

Completed

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

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