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

NCT00856115 | Completed DMC

• 3 other identifiers: CASE4208P30CA043703CASE 4208-CC498
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• Factors that influence appraisal and diagnostic delay

  45-60 minute interview

Study Arms (4)

African American Female

Other: medical chart review; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Other: survey administration

African American Male

Other: medical chart review; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Other: survey administration

Caucasian Female

Other: medical chart review; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Other: survey administration

Caucasian Male

Other: medical chart review; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Other: survey administration

Interventions

medical chart review OTHER

Patient charts are reviewed to obtain medical data.

African American Female; African American Male; Caucasian Female; Caucasian Male

questionnaire administration OTHER

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.

African American Female; African American Male; Caucasian Female; Caucasian Male

study of socioeconomic and demographic variables OTHER

Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity).

African American Female; African American Male; Caucasian Female; Caucasian Male

survey administration OTHER

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 Female; African American Male; Caucasian Female; Caucasian Male

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Lake/University Ireland Cancer Center

Cleveland, Ohio, 44060, United States

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Southwest General Health Center

Cleveland, Ohio, 44130, United States

Location

UH-Green Road

South Euclid, Ohio, 44121, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sonja Harris-Haywood, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 5, 2009
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

US (4)