- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00856115
Differences in Timely Cancer Diagnosis in African American and Caucasian Patients With Newly Diagnosed Colorectal Cancer
Appraisal Delay and Disparities in Timely Cancer Diagnosis
RATIONALE: Gathering information about timely diagnosis in African American and Caucasian patients with newly diagnosed colorectal cancer may help doctors learn more about factors that influence a diagnosis and plan the best treatment.
PURPOSE: This phase I trial is studying differences in timely cancer diagnosis in African American patients and in Caucasian patients with newly diagnosed colorectal cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Identify and examine the factors that influence appraisal and diagnostic delay by focusing on recognition, perception, communication, and response to pre-diagnosis cancer symptoms in African American and Caucasian patients with newly diagnosed colorectal cancer.
OUTLINE: This is a multicenter study. Patients are stratified according to race (African-American vs Caucasian) and gender (male vs female).
Patients undergo a 45-60 minute interview to obtain information on variations in symptom perception, assessment, and patient-physician communication process. Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity), information of close confidants (i.e., relationship, family history of cancer, and caregiver/decision-making status), and physician characteristics. Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
Patient charts are reviewed to obtain medical data.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
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Cleveland, Ohio, United States, 44106-5065
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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Cleveland, Ohio, United States, 44060
- Lake/University Ireland Cancer Center
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Cleveland, Ohio, United States, 44130
- Southwest General Health Center
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South Euclid, Ohio, United States, 44121
- UH-Green Road
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 21 years of age or older
- Cognitively able to participate in an interview
- Diagnosed with Colorectal cancer
- Patient at University Hospitals, Case Western Reserve University, or Cleveland Clinic Foundation
- diagnosed within 6 months of the scheduled interview
- have no prior history of colon cancer or cancer of any other major organ system
- any stage of cancer
- Patient will have described their symptoms to their PCPs
- Patient will have acted as their own decision maker
- Must be African American or Caucasian
Exclusion Criteria
- No disease discovered by previous routine screening or by other unintentional detection procedure (i.e., without symptom appraisal process or communicating specific symptoms to physicians)
- Not living in nursing or assisted living facilities
- Cognitive impairment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
African American Female
|
Patient charts are reviewed to obtain medical data.
Patients undergo a 45-60 minute interview to obtain information on variations in symptom perception, assessment, and patient-physician communication process.
Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity), information of close confidants (i.e., relationship, family history of cancer, and caregiver/decision-making status), and physician characteristics.
Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity).
Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
|
|
African American Male
|
Patient charts are reviewed to obtain medical data.
Patients undergo a 45-60 minute interview to obtain information on variations in symptom perception, assessment, and patient-physician communication process.
Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity), information of close confidants (i.e., relationship, family history of cancer, and caregiver/decision-making status), and physician characteristics.
Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity).
Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
|
|
Caucasian Female
|
Patient charts are reviewed to obtain medical data.
Patients undergo a 45-60 minute interview to obtain information on variations in symptom perception, assessment, and patient-physician communication process.
Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity), information of close confidants (i.e., relationship, family history of cancer, and caregiver/decision-making status), and physician characteristics.
Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity).
Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
|
|
Caucasian Male
|
Patient charts are reviewed to obtain medical data.
Patients undergo a 45-60 minute interview to obtain information on variations in symptom perception, assessment, and patient-physician communication process.
Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity), information of close confidants (i.e., relationship, family history of cancer, and caregiver/decision-making status), and physician characteristics.
Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity).
Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Factors that influence appraisal and diagnostic delay
Time Frame: 45-60 minute interview
|
45-60 minute interview
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sonja Harris-Haywood, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE4208 (OTHER: Case Comprehensive Cancer Center)
- P30CA043703 (U.S. NIH Grant/Contract)
- CASE 4208-CC498 (OTHER: Cancer Center IRB)
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