Study of Anxiety in African American Men With Prostate Cancer



Status:Recruiting
Conditions:Anxiety, Prostate Cancer, Cancer, Depression
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:10/19/2013
Start Date:September 2007

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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.

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
We found this trial at
5
sites
Jamaica, New York 11432
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Brooklyn, NY
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1275 York Avenue
New York, New York 10065
212-639-2000
Memorial Sloan-Kettering Cancer Center Memorial Sloan-Kettering Cancer Center — the world's oldest and largest private...
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New York, NY
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Brooklyn, New York 11203
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Brooklyn, NY
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160 E 34th St
New York, New York 10016
(212) 731-5001
NYU Cancer Institute at New York University Medical Center The Perlmutter Cancer Center takes a...
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New York, NY
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