Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00503646

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 Psychosocial Effects of Cancer and Its Treatment Sexual Dysfunction and Infertility Sexuality	Other: communication intervention Other: counseling intervention Other: questionnaire administration Procedure: psychosocial assessment and care

Study Type:	Interventional
Study Design:	Allocation: Randomized
Official Title:	Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Infertility Prostate Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Feasibility and acceptability [ Designated as safety issue: No ]
Descriptive characteristics of study measures [ Designated as safety issue: No ]
Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	May 2007
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To evaluate the feasibility and acceptability of conducting a randomized clinical trial evaluating communication and intimacy-enhancing intervention (CI) vs usual care (UC).
To collect descriptive information and basic psychometrics on proposed study measures.
To gather preliminary data regarding the impact of CI on couples' psychosocial adaptation, relationship closeness, and sexual intimacy in order to calculate power for a larger full scale trial.

OUTLINE: This is a multicenter study. Patients and their partners are randomized to 1 of 2 intervention arms.

Arm I: Patients and their partners receive communication and intimacy-enhancing intervention (CI) once a week comprising the following five 90-minute sessions: Rationale and Overview; Basic Communication; Intimacy and Sexuality; Improving Intimacy; and Reflecting on Changes and Cancer Survivorship.
Arm II: 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).

Physical impairment, psychological adjustment, relationship closeness, relationship communication, sexual function and satisfaction, male self-esteem, relationship satisfaction, intervention evaluation, and erectile dysfunction treatment utilization, and referral are assessed at 1 week post-intervention or at 6-8 weeks post baseline and then at 3 months (for patients and their partners in arm I) and at 8 weeks post-baseline and then at 3 months (for patients and their partners in arm II).

PROJECTED ACCRUAL: A total of 50 patients and 50 partners 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:

Patient has a primary diagnosis of localized (early stage) prostate cancer
- Has undergone surgery within the past year
Patient and partner married or cohabiting and relationship duration ≥ 1 year

PATIENT CHARACTERISTICS:

ECOG performance status 0 or 1 at the time of initial recruitment
Lives within 2-hour commuting distance from recruitment center (MSKCC or FCCC)
No significant self-identified 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: NCT00503646

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10022
Contact: Christian J. Nelson, PhD 646-888-0030 nelsonc@mskcc.org
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	David W. Kissane, MD	Memorial Sloan-Kettering Cancer Center
Principal Investigator:	Christian J. Nelson, PhD	Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

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

Publications:

Manne S, Badr H, Zaider T, Nelson C, Kissane D. Cancer-related communication, relationship intimacy, and psychological distress among couples coping with localized prostate cancer. J Cancer Surviv. 2010 Mar;4(1):74-85. Epub 2009 Dec 6.

ClinicalTrials.gov Identifier:	NCT00503646 History of Changes
Other Study ID Numbers:	CDR0000557017, MSKCC-07069
Study First Received:	July 17, 2007
Last Updated:	February 18, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

psychosocial effects of cancer and its treatment
sexual dysfunction and infertility
sexuality and reproductive issues

stage IIB prostate cancer
stage IIA prostate cancer
stage I prostate cancer

Additional relevant MeSH terms:

Infertility
Prostatic Neoplasms
Genital Diseases, Male
Genital Diseases, Female
Genital Neoplasms, Male

Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012