Colorectal CancerNCT00856115
Differences in Timely Cancer Diagnosis in African American and Caucasian Patients With Newly Diagnosed Colorectal Cancer
An observational study of Colorectal Cancer, run by Case Comprehensive Cancer Center at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- medical chart review, questionnaire administration and study of socioeconomic and demographic variables
- How many people
- 84 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2008to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: African American patients and Caucasian patients with newly diagnosed colorectal cancer.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lake/University Ireland Cancer Center
Cleveland, Ohio, 44060
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Southwest General Health Center
Cleveland, Ohio, 44130
UH-Green Road
South Euclid, Ohio, 44121
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- medical chart review, questionnaire administration, study of socioeconomic and demographic variables, survey administration
- 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
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
Patient charts are reviewed to obtain medical data.
questionnaire administrationOther
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 variablesOther
Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity).
survey administrationOther
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 group | Role | What they receive |
|---|---|---|
| African American Female | Not described Receives: Other: medical chart review; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Other: survey administration | |
| African American Male | Not described Receives: Other: medical chart review; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Other: survey administration | |
| Caucasian Female | Not described Receives: Other: medical chart review; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Other: survey administration | |
| Caucasian Male | Not described Receives: Other: medical chart review; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Other: survey administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors that influence appraisal and diagnostic delay
Measured: 45-60 minute interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sonja Harris-Haywood, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856115
- Sponsor's protocol ID
- CASE4208
- Other IDs
- P30CA043703, CASE4208, CASE 4208-CC498
- Status last verified
- Jul 2014
- First submitted
- 4 Mar 2009
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appraisal Delay and Disparities in Timely Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT00856115
- Acronym / sponsor ID
- CASE4208
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- African American patients and Caucasian patients with newly diagnosed colorectal cancer.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical chart reviewPatient charts are reviewed to obtain medical data. | Other | African American Female, African American Male, Caucasian Female, Caucasian Male |
| questionnaire administrationPatients 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 | African American Female, African American Male, Caucasian Female, Caucasian Male |
| study of socioeconomic and demographic variablesPatients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity). | Other | African American Female, African American Male, Caucasian Female, Caucasian Male |
| survey administrationPatients 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 | African American Female, African American Male, Caucasian Female, Caucasian Male |
Primary outcome
Factors that influence appraisal and diagnostic delay
Time frame: 45-60 minute interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonja Harris-Haywood, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Case Comprehensive Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors that influence appraisal and diagnostic delay (time frame: 45-60 minute interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.