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

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial

Brief Summary

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.

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Other, Randomized

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

Condition ^†

Cancer-Related Problem/Condition
Prostate Cancer

Intervention ^†

Other: counseling
Other: questionnaire administration
Procedure: psychosocial assessment and care

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

100

Start Date ^†

May 2007

Completion Date

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00503646

Organization ID

CDR0000557017

Secondary IDs ^††

MSKCC-07069

Study Sponsor ^†

Memorial Sloan-Kettering Cancer Center

Collaborators ^††

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2008

First Received Date ^†

July 17, 2007

Last Updated Date

February 6, 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.