Study of Anxiety in African American Men With Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00602654
First received: January 19, 2008
Last updated: February 18, 2011
Last verified: July 2009
  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
Anxiety Disorder
Depression
Prostate Cancer
Other: medical chart review
Other: questionnaire administration
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

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

Resource links provided by NLM:


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 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.

  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
  • 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
Kings County Hospital Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Contact Person     718-245-3901        
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Richard J. Macchia, MD     718-270-2554     richard.macchia@downstate.edu    
Queens Cancer Center of Queens Hospital Recruiting
Jamaica, New York, United States, 11432
Contact: Margaret Kermeny     718-883-4031        
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    
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00602654     History of Changes
Other Study ID Numbers: CDR0000572399, MSKCC-07125
Study First Received: January 19, 2008
Last Updated: February 18, 2011
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Prostatic Neoplasms
Mental Disorders
Behavioral Symptoms
Mood Disorders
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013