Clinical trial NCT01982058: Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
Official title: Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Sexual Dysfunction and Infertility
Sexuality
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Rutgers Cancer Institute of New Jersey
name: Memorial Sloan Kettering Cancer Center
name: Fox Chase Cancer Center
First posted: 2013-11-13
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Psychological Functioning
timeFrame: 5 years
measure: Relationship Functioning
timeFrame: 5 years
Secondary outcomes:
measure: Intimacy
timeFrame: 5 years
measure: Relationship Communication
timeFrame: 5 years
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Newark
country: United States
facility: The University Hospital
state: New Jersey
city: Whippany
country: United States
facility: Garden State Urology
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon L Manne, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: