Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00503646
First received: July 17, 2007
Last updated: February 18, 2011
Last verified: July 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Sexual Dysfunction and Infertility Sexuality |
Other: communication intervention Other: counseling intervention Other: questionnaire administration Procedure: psychosocial assessment and care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized |
| Official Title: | Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Feasibility and acceptability [ Designated as safety issue: No ]
- Descriptive characteristics of study measures [ Designated as safety issue: No ]
- Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503646
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10022 | |
| Contact: Christian J. Nelson, PhD 646-888-0030 nelsonc@mskcc.org | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center - Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | David W. Kissane, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Christian J. Nelson, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00503646 History of Changes |
| Other Study ID Numbers: | CDR0000557017, MSKCC-07069 |
| Study First Received: | July 17, 2007 |
| Last Updated: | February 18, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Sexual Dysfunctions, Psychological Genital Diseases, Female Infertility Prostatic Neoplasms Genital Diseases, Male Genital Neoplasms, Male |
Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013