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. (see Contacts and Locations)
Verified October 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
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
First received: December 21, 2007
Last updated: October 6, 2014
Last verified: October 2014
  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:


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 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Brian McNeil, MD         
Principal Investigator: Brian McNeil, MD         
Kings County Hopsital Center Completed
Brooklyn, New York, United States
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:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581672     History of Changes
Obsolete Identifiers: NCT00602654
Other Study ID Numbers: 07-125
Study First Received: December 21, 2007
Last Updated: October 6, 2014
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:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014