Study of Anxiety in African American Men With Prostate Cancer
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 19, 2008 | ||||||||
| Last Updated Date | February 18, 2011 | ||||||||
| Start Date ICMJE | September 2007 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Psychosocial measures [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00602654 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Anxiety in African American Men With Prostate Cancer | ||||||||
| Official Title ICMJE | Anxiety in African-American Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an African-American Sample | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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 either in person or by phone. 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Not Provided | ||||||||
| Study Population | Not Provided | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Not Provided | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00602654 | ||||||||
| Other Study ID Numbers ICMJE | CDR0000572399, MSKCC-07125 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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