Clinical trial NCT00856115: Differences in Timely Cancer Diagnosis in African American and Caucasian Patients With Newly Diagnosed Colorectal Cancer
Official title: Appraisal Delay and Disparities in Timely Cancer Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: 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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-03-05
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: African American patients and Caucasian patients with newly diagnosed colorectal cancer.

Brief 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.

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 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

Primary outcomes:
measure: Factors that influence appraisal and diagnostic delay
timeFrame: 45-60 minute interview
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Lake/University Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Southwest General Health Center
state: Ohio
city: South Euclid
country: United States
facility: UH-Green Road
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Sonja Harris-Haywood, MD
role: PRINCIPAL_INVESTIGATOR
References: