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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00602654 |
Purpose
RATIONALE: Questionnaires that measure anxiety, depression, and quality of life may improve the ability to plan treatment for patients with prostate cancer.
PURPOSE: This clinical trial is studying anxiety, depression, and quality of life in African-American patients with prostate cancer.
| Condition | Intervention |
|
Cancer-Related Problem/Condition Prostate Cancer |
Procedure: medical chart review Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: questionnaire administration |
| MedlinePlus related topics: | Anxiety Cancer Depression Prostate Cancer |
| Study Type: | Observational |
| Official Title: | Anxiety in African-American Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an African-American Sample |
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
All patients complete a 5-minute Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire measuring general prostate cancer anxiety, PSA anxiety, and fear of recurrence. They will complete six other questionnaires, each requiring 5 minutes to complete, and focusing on anxiety, depression, and quality of life measures. These include the demographic questionnaire; the Distress Thermometer visual analogue scale; the Hospital Anxiety and Depression Scale (HADS); the Functional Assessment of Cancer Therapy Scale-Prostate (FACT-P); the Center for Epidemiologic Studies Depression Scale (CES-D) assessing the frequency of depressive symptoms the patient experienced in the past week; and the Karnofsky Patient Performance Rating Scale (KPRS). Within 1 week after receiving their PSA test results, some patients will undergo an additional telephone interview conducted by a research study assistant to complete the MAX-PC, the HADS, and the Distress Thermometer questionnaires.
PROJECTED ACCRUAL: A total of 150 patients (75 patients with early stage disease and 75 patients with late stage disease) will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of prostate cancer
Advanced stage disease meeting 1 of the following criteria:
Men who identify themselves as Black, African-American, or men of African descent and non-Hispanic will be eligible for the study
Men who identify themselves as Black and Hispanic are included
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and 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 | |||||
| NYU Cancer Institute at New York University Medical Center | Recruiting | ||||
| New York, New York, United States, 10016 | |||||
| Contact: Iman Osman, MD 212-686-7500 ext. 3522 osmani01@popmail.med.nyu.edu | |||||
| Queens Cancer Center of Queens Hospital | Recruiting | ||||
| Jamaica, New York, United States, 11432 | |||||
| Contact: Margaret Kermeny 718-883-4031 | |||||
| SUNY Downstate Medical Center | Recruiting | ||||
| Brooklyn, New York, United States, 11203 | |||||
| Contact: Richard J. Macchia, MD 718-270-2554 richard.macchia@downstate.edu | |||||
| Memorial Sloan-Kettering Cancer Center |
| National Cancer Institute (NCI) |
| Principal Investigator: | Christian J. Nelson, PhD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Andrew J. Roth, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000572399, MSKCC-07125 |
| First Received: | January 19, 2008 |
| Last Updated: | October 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00602654 |
| Health Authority: | Unspecified |
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