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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Unknown

Conditions: Sexuality and Reproductive Issues; Psychosocial Effects of Cancer and Its Treatment; Sexual Dysfunction and Infertility; Prostate Cancer

Treatments: Other: communication intervention; Other: counseling intervention; Procedure: psychosocial assessment and care; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00503646

07-069

MSKCC-07069

Details and patient eligibility

About

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.

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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