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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00503646
• Other study ID #: 07-069
• Secondary ID: MSKCC-07069
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2007
• Last updated: September 16, 2013
• Start date: May 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized

Related Conditions & MeSH terms

• Infertility
• Prostate Cancer
• Prostatic Neoplasms
• Psychosocial Effects of Cancer and Its Treatment
• Sexual Dysfunction and Infertility
• Sexuality and Reproductive Issues

Intervention

Other:
• communication intervention

• counseling intervention

• questionnaire administration

Procedure:
• psychosocial assessment and care

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1007/s11764-009-0109-y. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability			No
Primary	Descriptive characteristics of study measures			No
Primary	Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy			No