Clinical trial NCT00503646: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Sexual Dysfunction and Infertility
Sexuality and Reproductive Issues
Keywords: psychosocial effects of cancer and its treatment
sexual dysfunction and infertility
sexuality and reproductive issues
stage IIB prostate cancer
stage IIA prostate cancer
stage I prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

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.

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

Primary outcomes:
measure: Feasibility and acceptability
measure: Descriptive characteristics of study measures
measure: Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David W. Kissane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Christian J. Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 2009 Dec 6.