Prostate Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

100

Study ID:

NCT00503646

Recruitment Status:

Unknown status

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 2 Locations for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10022, United States More Info
Christian J. Nelson, PhD
Contact
646-888-0030
[email protected]
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States More Info
Clinical Trials Office - Fox Chase Cancer Center - Philadelphi
Contact
215-728-4790

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

100

Study ID:

NCT00503646

Recruitment Status:

Unknown status

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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