NCT00503646

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Last Updated

September 17, 2013

Status Verified

July 1, 2009

Enrollment Period

3 years

First QC Date

July 17, 2007

Last Update Submit

September 16, 2013

Conditions

Prostate CancerPsychosocial Effects of Cancer and Its TreatmentSexual Dysfunction and InfertilitySexuality and Reproductive Issues

Keywords

psychosocial effects of cancer and its treatmentsexual dysfunction and infertilitysexuality and reproductive issuesstage IIB prostate cancerstage IIA prostate cancerstage I prostate cancer

Outcome Measures

Primary Outcomes (3)

  • Feasibility and acceptability

  • Descriptive characteristics of study measures

  • Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy

Interventions

communication interventionOTHER
counseling interventionOTHER
questionnaire administrationOTHER
psychosocial assessment and carePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10022, United States

RECRUITING

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 19967408RESULT

MeSH Terms

Conditions

Prostatic NeoplasmsSexual Dysfunction, PhysiologicalInfertilitySexuality

Interventions

CounselingPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesSexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesRehabilitationTherapeutics

Study Officials

  • David W. Kissane, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

  • Christian J. Nelson, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

May 1, 2007

Primary Completion

May 1, 2010

Last Updated

September 17, 2013

Record last verified: 2009-07

Locations

US(2)