Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00483678

Purpose

RATIONALE: A couples therapy program may enhance intimacy and reduce psychological distress in patients with prostate cancer and in their partners.

PURPOSE: This randomized clinical trial is studying how well couples therapy enhances intimacy and reduces psychological distress in patients with advanced or recurrent prostate cancer and in their partners.

Condition	Intervention
Cancer-Related Problem/Condition Prostate Cancer	Procedure: counseling Procedure: psychosocial assessment and care Procedure: questionnaire administration

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility of Intimacy-Enhancing Couples Therapy (IECT) (e.g., eligibility rate, acceptance rate, attendance rate, satisfaction) assessed at baseline and at 1 month after completion of study intervention [ Designated as safety issue: No ]
Comparison of the preliminary effect of IECT vs usual care on global psychological distress and relationship intimacy as assessed by the BSI-18 at baseline and at 1 month after completion of study intervention [ Designated as safety issue: No ]
Relationship functioning, including intimacy, communication, and satisfaction (cancer-specific and overall) as assessed by the CRCS and A-DAS at baseline and at 1 month after completion of study intervention [ Designated as safety issue: No ]

Estimated Enrollment:	152
Study Start Date:	April 2007
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the feasibility of Intimacy-Enhancing Couples Therapy (IECT) for patients with advanced or recurrent prostate cancer and their partners.
Compare the effect of IECT vs usual care on patients' and their partners' level of global psychological distress.
Compare the effect of IECT vs usual care on relationship intimacy in these participants.

OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are stratified according to marital distress based on partners' scores on the Abbreviated Dyadic Adjustment Scale (high [< 21] vs low [≥ 21]). Patients and their partners are randomized to 1 of 2 arms.

Arm I: Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions: the Story of Cancer; Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping, Support, and Adaptation. Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention.
Arm II: Patients and their partners receive standard psychosocial care. All participants complete questionnaires assessing psychological distress, intimacy, communication patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month after completion of study intervention.

PROJECTED ACCRUAL: A total of 76 couples will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of primary prostate cancer
- Advanced or recurrent disease
Receiving concurrent hormonal therapy
Married and/or co-habitating with a partner for ≥ 1 year
T-score > 50 on Brief Symptom Inventory-18 questionnaire (patient and/or partner)

PATIENT CHARACTERISTICS:

Normal cognitive functioning
Able to speak and read English
No significant hearing impairment that would preclude study participation

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483678

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: David W. Kissane, MD 646-888-0019
United States, Pennsylvania
Fox Chase Cancer Center - Cheltenham	Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Sharon Manne, PhD 215-728-5523 sharon.manne@fccc.edu

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

David W. Kissane, MD

Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000547220, MSKCC-07043
Study First Received:	June 6, 2007
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00483678
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

psychosocial effects/treatment
sexual dysfunction and infertility
sexuality and reproductive issues

recurrent prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Infertility
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009