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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00856115
First received: March 4, 2009
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Other: medical chart review
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Other: survey administration
Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Appraisal Delay and Disparities in Timely Cancer Diagnosis

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Factors that influence appraisal and diagnostic delay [ Time Frame: 45-60 minute interview ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: November 2008
Study Completion Date: January 2014
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
African American Female Other: medical chart review
Patient charts are reviewed to obtain medical data.
Other: 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.
Other: 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).
Other: 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.
African American Male Other: medical chart review
Patient charts are reviewed to obtain medical data.
Other: 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.
Other: 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).
Other: 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.
Caucasian Female Other: medical chart review
Patient charts are reviewed to obtain medical data.
Other: 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.
Other: 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).
Other: 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.
Caucasian Male Other: medical chart review
Patient charts are reviewed to obtain medical data.
Other: 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.
Other: 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).
Other: 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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

African American patients and Caucasian patients with newly diagnosed colorectal cancer.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856115

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
Southwest General Health Center
Cleveland, Ohio, United States, 44130
UH-Green Road
South Euclid, Ohio, United States, 44121
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Sonja Harris-Haywood, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00856115     History of Changes
Other Study ID Numbers: CASE4208, P30CA043703, CASE4208, CASE 4208-CC498
Study First Received: March 4, 2009
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014