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



Status:Recruiting
Conditions:Prostate Cancer, Cancer, Cancer, Psychiatric, Women's Studies
Therapuetic Areas:Oncology, Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:May 2007

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

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.

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.

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
We found this trial at
2
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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