Differences in Timely Cancer Diagnosis in African American and Caucasian Patients With Newly Diagnosed Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Appraisal Delay and Disparities in Timely Cancer Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856115
• Other study ID #: CASE4208
• Secondary ID: P30CA043703CASE4
• Status: Completed
• Phase: Phase 1
• First received: March 4, 2009
• Last updated: July 14, 2014
• Start date: November 2008
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 2014
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• medical chart review
Patient charts are reviewed to obtain medical data.
• questionnaire administration
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.
• study of socioeconomic and demographic variables
Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity).
• survey administration
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.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Lake/University Ireland Cancer Center	Cleveland	Ohio
United States	Southwest General Health Center	Cleveland	Ohio
United States	UH-Green Road	South Euclid	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors that influence appraisal and diagnostic delay		45-60 minute interview	No