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Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01982058
First Posted: November 13, 2013
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rutgers Cancer Institute of New Jersey
Memorial Sloan Kettering Cancer Center
Fox Chase Cancer Center
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
  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: None (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 ]
    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 ]
    Relationship satisfaction is assessed using the Dyadic Adjustment Scale


Secondary Outcome Measures:
  • Intimacy [ Time Frame: 5 years ]
    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 ]

    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.



Enrollment: 483
Actual Study Start Date: August 18, 2011
Estimated Study Completion Date: July 2018
Primary Completion Date: August 7, 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982058


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

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01982058     History of Changes
Other Study ID Numbers: 131023
0220100274 ( Other Identifier: IRB number )
NCI-2012-00552 ( Other Identifier: CTRP (Clinical Trails Reporting Program) )
First Submitted: June 24, 2013
First Posted: November 13, 2013
Last Update Posted: November 16, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Infertility
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Genital Diseases, Female