Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

This study is currently recruiting participants.
Verified November 2013 by Rutgers, The State University of New Jersey
Sponsor:
Collaborators:
Memorial Sloan-Kettering Cancer Center
Fox Chase Cancer Center
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier:
NCT01982058
First received: June 24, 2013
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Sexual Dysfunction and Infertility
Sexuality
Other: communication intervention
Other: counseling intervention
Other: nutrition intervention
Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Psychological Functioning [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • Relationship Functioning [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Relationship satisfaction is assessed using the Dyadic Adjustment Scale


Secondary Outcome Measures:
  • Intimacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • Relationship Communication [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 372
Study Start Date: April 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intimacy-Enhancing Couples
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 Other: counseling intervention Other: questionnaire administration
Active Comparator: General Health and Wellness
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 Other: nutrition intervention Other: questionnaire administration
Usual Care
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01982058

Contacts
Contact: Sharon L Manne, Ph.D. 732-235-6759 mannesl@umdnj.edu
Contact: George Olekson, MA 732-235-6802 oleksoge@umdnj.edu

Locations
United States, New Jersey
The Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: George Olekson, MA    732-235-6802    oleksoge@umdnj.edu   
Principal Investigator: Sharon L Manne, Ph.D         
The University Hospital Not yet recruiting
Newark, New Jersey, United States, 07103
Contact: George Olekson, MA    732-235-6802    oleksoge@umdnj.edu   
Principal Investigator: Mark L Jordan, MD         
Garden State Urology Recruiting
Whippany, New Jersey, United States, 07981
Contact: George Olekson, MA    732-235-6802    oleksoge@umdnj.edu   
Principal Investigator: David Taylor, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10022
Contact: Shira Hichenberg, B.A.    646-888-0051    hichenbs@mskcc.org   
Principal Investigator: Talia I Zaider, Ph.D.         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Sara E Frederick, MS    215-214-3794    sara.worhach@fccc.edu   
Principal Investigator: Carolyn Heckman, Ph.D.         
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Memorial Sloan-Kettering Cancer Center
Fox Chase Cancer Center
Investigators
Principal Investigator: Sharon L Manne, Ph.D. Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier: NCT01982058     History of Changes
Other Study ID Numbers: 131023, 0220100274
Study First Received: June 24, 2013
Last Updated: November 5, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Additional relevant MeSH terms:
Infertility
Prostatic Neoplasms
Sexual Dysfunctions, Psychological
Genital Diseases, Male
Genital Diseases, Female
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014