Jamaica, New York 11432


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.


Study summary:

OBJECTIVES: Primary - To establish the psychometric properties of the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) in African American men with prostate cancer. - To establish the reliability of the MAX-PC in African American men with prostate cancer. - To establish the validity of the MAX-PC in African American men with prostate cancer. - To confirm the factor structure of the MAX-PC in this sample. - To test the sensitivity to change of the MAX-PC in this sample. Secondary - To explore the prevalence of distress, anxiety, and depression in African American men with prostate cancer. 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.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of prostate cancer - Early stage disease (T1or T2, N0, M0) - Advanced stage disease meeting 1 of the following criteria: - Locally advanced disease (T3 or T4, N0, M0) - Metastatic disease (T3 or T4, N1-3 or M1a-c) - Undergoing monitoring for prostate-specific antigen (PSA) levels - Men who identify themselves as Black, African-American, or men of African descent and non-Hispanic will be eligible for the study - "Black, African American, or of African descent" will be defined as men having origins in any black racial groups of Africa - "Haitian" will be used in addition to "Black" or "African American" to help clarify this group - Men who identify themselves as Black and Hispanic are included - "Hispanic" will be defined as a person of Mexican, Puerto Rican, Cuban, South or Central American, or other Spanish culture or origin - "Latino" and "Spanish origin" will be used in addition to "Hispanic" to help clarify this group - No other non-Black or non-African American ethnic groups PATIENT CHARACTERISTICS: - Able to comprehend and complete questionnaires in English - No major psychopathology or cognitive impairment likely, in the judgment of the research staff, to interfere with the participation or completion of the protocol PRIOR CONCURRENT THERAPY: - Not specified


NCT ID:

NCT00602654


Primary Contact:

Principal Investigator
Christian J. Nelson, PhD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

Jamaica, New York 11432
United States

Margaret Kermeny
Phone: 718-883-4031

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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