Study of Anxiety in African American Men With Prostate Cancer
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Anxiety Disorder Depression Prostate Cancer |
Other: medical chart review Other: questionnaire administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Official Title: | Anxiety in African-American Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an African-American Sample |
- Psychosocial measures [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Kings County Hospital Center | Recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact: Contact Person 718-245-3901 | |
| SUNY Downstate Medical Center | Recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact: Richard J. Macchia, MD 718-270-2554 richard.macchia@downstate.edu | |
| Queens Cancer Center of Queens Hospital | Recruiting |
| Jamaica, New York, United States, 11432 | |
| Contact: Margaret Kermeny 718-883-4031 | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10022 | |
| Contact: Christian J. Nelson, PhD 646-888-0030 nelsonc@mskcc.org | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Iman Osman, MD 212-686-7500 ext. 3522 osmani01@popmail.med.nyu.edu | |
| Principal Investigator: | Christian J. Nelson, PhD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Andrew J. Roth, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00602654 History of Changes |
| Other Study ID Numbers: | CDR0000572399, MSKCC-07125 |
| Study First Received: | January 19, 2008 |
| Last Updated: | February 18, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
depression anxiety disorder stage I prostate cancer stage IIB prostate cancer |
stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder Prostatic Neoplasms Mental Disorders Behavioral Symptoms Mood Disorders |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013