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Study of Anxiety in African American Men With Prostate Cancer
This study is currently recruiting participants.
Study NCT00602654   Information provided by National Cancer Institute (NCI)
First Received: January 19, 2008   Last Updated: August 5, 2009   History of Changes

January 19, 2008
August 5, 2009
September 2007
September 2010   (final data collection date for primary outcome measure)
Psychosocial measures [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00602654 on ClinicalTrials.gov Archive Site
 
 
 
Study of Anxiety in African American Men With Prostate Cancer
Anxiety in African-American Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an African-American Sample

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.

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.

 
Observational
 
  • Anxiety Disorder
  • Depression
  • Prostate Cancer
  • Other: medical chart review
  • Other: questionnaire administration
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
150
 
September 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
 
United States
 
NCT00602654
 
CDR0000572399, MSKCC-07125
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
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP