- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581672
Anxiety in Black Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an Sample of Black Men
May 3, 2022 updated by: Memorial Sloan Kettering Cancer Center
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
224
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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Brooklyn, New York, United States, 11203
- Downstate Medical Center
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Brooklyn, New York, United States
- Kings County Hopsital Center
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Black men with prostate cancer
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
questionnaires
Black men with prostate cancer
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
within one to three weeks of receiving their PSA scores from their physician
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
within one to three weeks of receiving their PSA scores from their physician
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2010
Primary Completion (Actual)
May 3, 2022
Study Completion (Actual)
May 3, 2022
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 27, 2007
First Posted (Estimate)
December 28, 2007
Study Record Updates
Last Update Posted (Actual)
May 4, 2022
Last Update Submitted That Met QC Criteria
May 3, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-125
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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