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Study of Anxiety in African American Men With Prostate Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008

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   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Psychosocial measures [ Designated as safety issue: No ]

Estimated Enrollment:   150
Study Start Date:   September 2007
Estimated Primary Completion Date:   September 2010 (Final data collection date for primary outcome measure)

Detailed Description:

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. 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

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 on the day of current clinic visit or prior to clinic visit, but prior to being informed of the results
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602654

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    

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
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  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000572399, MSKCC-07125
First Received:   January 19, 2008
Last Updated:   October 22, 2008
ClinicalTrials.gov Identifier:   NCT00602654
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
depression  
anxiety disorder  
stage I prostate cancer  
stage II prostate cancer  
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Study placed in the following topic categories:
Depression
Prostatic Diseases
Genital Neoplasms, Male
Anxiety Disorders
Urogenital Neoplasms
Genital Diseases, Male
Depressive Disorder
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 30, 2008




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