Anxiety in Black Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an Sample of Black Men

This study is currently recruiting participants.

Verified December 2011 by Memorial Sloan-Kettering Cancer Center

First Received on December 21, 2007. Last Updated on December 23, 2011 History of Changes

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborators:	University School of Medicine(VA-NYU) State University of New York - Downstate Medical Center Kings County Hospital Center
Information provided by (Responsible Party):	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00581672

Purpose

This study is being done to see if a standard tool used to check anxiety in white men works well for Black men. The tool is used only for men who have prostate cancer. It is meant to see how the cancer affects men. If the investigators have a good tool, it is more likely that the investigators can help those who have high levels of anxiety. This test is known as the Memorial Anxiety Scale for Prostate Cancer (also called the MAX-PC).

Condition	Intervention
Prostate Cancer	Behavioral: questionnaires of quality of life

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Anxiety in Black Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an Sample of Black Men

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To establish the psychometric properties of the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) in Black men with prostate cancer. [ Time Frame: within one to three weeks of receiving their PSA scores from their physician ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To explore the prevalence of distress, anxiety, and depression in Black men with prostate cancer. [ Time Frame: within one to three weeks of receiving their PSA scores from their physician ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
questionnaires Black men with prostate cancer	Behavioral: questionnaires of quality of life Subjects will be asked to complete the MAX-PC along with additional psychosocial questionnaires which include anxiety, depression coping methods, resilience spirituality, religiosity, and quality of life measures and will take approximately one 30 to 45 minutes to complete by patient.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Black men with prostate cancer

Criteria

Inclusion Criteria:

18 years of age or older
Patients who are being monitored by PSA tests, who will have a PSA test done on the day of their current clinic visit or prior to their clinic visit, but prior to being informed of the results
Diagnosis of prostate cancer
Ethnicity: Black, African-American, or of African descent (and will include those men who identify as Black and Hispanic).
Ability to comprehend and complete questionnaires in English

Exclusion Criteria:

Major psychopathology or cognitive impairment likely, in the judgment of the research staff, to interfere with the participation or completion of the protocol
Other non-Black or non-African-American ethnic groups

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581672

Contacts

Contact: Christian Nelson, PhD	646-888-0030
Contact: Andrew Roth, MD	646-888-0024

Locations

United States, New York
Downstate Medical Center	Recruiting
Brooklyn, New York, United States, 11203
Contact: Richard Macchia, MD
Kings County Hopsital Center	Recruiting
Brooklyn, New York, United States
Contact: Adrian Llewellyn, MD
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Christian Nelson, PhD 646-888-0030

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

University School of Medicine(VA-NYU)

State University of New York - Downstate Medical Center

Kings County Hospital Center

Investigators

Principal Investigator:

Christian Nelson, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00581672 History of Changes
Other Study ID Numbers:	07-125
Study First Received:	December 21, 2007
Last Updated:	December 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Anxiety
Black men
Prostate Cancer
07-125

Additional relevant MeSH terms:

Anxiety Disorders
Prostatic Neoplasms
Mental Disorders
Genital Neoplasms, Male
Urogenital Neoplasms

Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012