Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners
NCT ID: NCT00503646
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2007-05-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
Interventions
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communication intervention
counseling intervention
questionnaire administration
psychosocial assessment and care
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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David W. Kissane, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Christian J. Nelson, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Facility Contacts
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Christian J. Nelson, PhD
Role: primary
Clinical Trials Office - Fox Chase Cancer Center - Philadelphi
Role: primary
References
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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.
Other Identifiers
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MSKCC-07069
Identifier Type: -
Identifier Source: secondary_id
07-069
Identifier Type: -
Identifier Source: org_study_id