NCT00581672

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
2.6 years until next milestone

Study Start

First participant enrolled

July 25, 2010

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2022

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

11.8 years

First QC Date

December 21, 2007

Last Update Submit

May 3, 2022

Conditions

Keywords

AnxietyBlack menProstate Cancer07-125

Outcome Measures

Primary Outcomes (1)

  • To establish the psychometric properties of the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) in Black men with prostate cancer.

    within one to three weeks of receiving their PSA scores from their physician

Secondary Outcomes (1)

  • To explore the prevalence of distress, anxiety, and depression in Black men with prostate cancer.

    within one to three weeks of receiving their PSA scores from their physician

Study Arms (1)

questionnaires

Black men with prostate cancer

Behavioral: questionnaires of quality of life

Interventions

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.

questionnaires

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Black men with prostate cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Kings County Hopsital Center

Brooklyn, New York, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • Martin CM, Schofield E, Napolitano S, Avildsen IK, Emanu JC, Tutino R, Roth AJ, Nelson CJ. African-centered coping, resilience, and psychological distress in Black prostate cancer patients. Psychooncology. 2022 Apr;31(4):622-630. doi: 10.1002/pon.5847. Epub 2021 Nov 9.

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesMental Disorders

Study Officials

  • Christian Nelson, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 28, 2007

Study Start

July 25, 2010

Primary Completion

May 3, 2022

Study Completion

May 3, 2022

Last Updated

May 4, 2022

Record last verified: 2022-05

Locations