Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Sexuality; Sexual Dysfunction and Infertility
• Intervention / Treatment: Other: questionnaire administration; Other: counseling intervention; Other: nutrition intervention; Other: communication intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 483
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: questionnaire administration; Other: counseling intervention; Other: communication intervention
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: questionnaire administration; Other: counseling intervention; Other: nutrition intervention
Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Memorial Sloan Kettering Cancer Center; Fox Chase Cancer Center; Rutgers Cancer Institute of New Jersey
• Investigators: Principal Investigator: Sharon L Manne, Ph.D., Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2011
• Primary Completion (Actual): August 7, 2017
• Study Completion (Actual): August 7, 2017

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: November 5, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Infertility
• Other Study ID Numbers: 0220100274 (Other Identifier: IRB number); NCI-2012-00552 (Other Identifier: CTRP (Clinical Trails Reporting Program)); 131023 (Other Identifier: Rutgers Cancer Institute of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO