CancerNCT00823394
African American Cancer Prevention Project: Establishing a Cohort to Investigate Health Disparities
An observational study of Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn if certain factors may affect cancer rates among African Americans. These factors include behavioral, social, and environmental factors including diet and physical activity, cigarette smoking, cancer screening, health care, neighborhood environment, and mental health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Questionnaire, Body Measurements and Self-help Materials
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2008to 31 Dec 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult attendees of Windsor Village United Methodist Church living in Houston.
Who may be able to join
- be age 18 years old and above
- read and write English
- live in the Houston metro area
- have a viable (working) telephone number and home address
Who cannot join
- 1) None.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to learn if certain factors may affect cancer rates among African Americans. These factors include behavioral, social, and environmental factors including diet and physical activity, cigarette smoking, cancer screening, health care, neighborhood environment, and mental health.
Read the detailed description
Study Procedures:
If you decide to take part in this study, you will complete study procedures at month 36 (the day you sign this consent form) and again every year for the next 2 years. These procedures include completing a questionnaire, having your body measurements taken, and receiving self-help materials.
At month 36, you will complete the questionnaire on a computer that is set up at the church in a private room. The questions will be about nutrition, exercise, tobacco and alcohol use, your neighborhood, age, education, social status, health status, stress, and racism. It should take about 75 minutes to complete. Your waist, hip, height, and weight will also be measured while you are in the private room.
Every year after that for the next 2 years, you will go back to the church to complete a new questionnaire each time. The questionnaires should take about 75 minutes to complete each time.
If you cannot get back to the church, you may complete the questionnaire over the phone. The study staff will provide you with the phone number and directions on how to complete the survey over the phone. Your measurements will be taken at the church, or at the Behavioral Research and Treatment Center (BRTC) at MD Anderson, whichever is more convenient for you.
At each study visit, you will also receive self-help materials on how to lower your risk for developing cancer.
Questionnaire Data:
Your questionnaire data will be used for research purposes only. Your responses will not be shared with your personal doctor. If you feel you need a doctor's opinion about anything that is asked about in the questionnaire (such as mental or emotional difficulties or symptoms), please contact your personal physician.
About 1 month after each you complete the questionnaire each time, the research staff will review and score your responses. If your scores suggest signs of depression, you will be given a list of resources for mental health screening.
Length of Study:
After 5 years, your active participation in this study will be over. You may be contacted in the future to see if you would agree to take part in other research studies.
This is an investigational study.
Up to 1,501 people will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Cancer
- Being tested
- Questionnaire, Body Measurements, Self-help Materials
- Keywords
- African American, Adults, African American Cancer Prevention Project, Health Disparities, Questionnaire, Body Measurements, Self-help, Cancer Rates, Prevention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Completed privately via computer at Windsor Village Church, approximately 75 minutes. Repeated at Months 12 and 24.
Body MeasurementsOther
Waist, hip, height, and weight measured privately. Repeated at Months 12 and 24.
Self-help MaterialsBehavioural
Information on how to lower risk for developing cancer.
| Study group | Role | What they receive |
|---|---|---|
| Windsor Village United Methodist Church | Questionnaire + Body Measurements + Self-help Materials Receives: Behavioral: Questionnaire; Other: Body Measurements; Behavioral: Self-help Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Study Establishing African American Cancer Prevention Project (AACP)
A longitudinal study to learn if and how certain behavioral, social, and environmental factors may affect cancer rates among African Americans as compared to other racial and ethnic groups.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study start5 Dec 2008
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorna H. McNeill, MPH, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823394
- Sponsor's protocol ID
- 2007-0970
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2009
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African American Cancer Prevention Project: Establishing a Cohort to Investigate Health Disparities
- ClinicalTrials.gov ID
- NCT00823394
- Acronym / sponsor ID
- 2007-0970
- Conditions
- Cancer
- Keywords
- African American, Adults, African American Cancer Prevention Project, Health Disparities, Questionnaire, Body Measurements, Self-help, Cancer Rates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 Dec 2008 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 Jan 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.
The goal of this research study is to learn if certain factors may affect cancer rates among African Americans. These factors include behavioral, social, and environmental factors including diet and physical activity, cigarette smoking, cancer screening, health care, neighborhood environment, and mental health.
Detailed description
Study Procedures:
If you decide to take part in this study, you will complete study procedures at month 36 (the day you sign this consent form) and again every year for the next 2 years. These procedures include completing a questionnaire, having your body measurements taken, and receiving self-help materials.
At month 36, you will complete the questionnaire on a computer that is set up at the church in a private room. The questions will be about nutrition, exercise, tobacco and alcohol use, your neighborhood, age, education, social status, health status, stress, and racism. It should take about 75 minutes to complete. Your waist, hip, height, and weight will also be measured while you are in the private room.
Every year after that for the next 2 years, you will go back to the church to complete a new questionnaire each time. The questionnaires should take about 75 minutes to complete each time.
If you cannot get back to the church, you may complete the questionnaire over the phone. The study staff will provide you with the phone number and directions on how to complete the survey over the phone. Your measurements will be taken at the church, or at the Behavioral Research and Treatment Center (BRTC) at MD Anderson, whichever is more convenient for you.
At each study visit, you will also receive self-help materials on how to lower your risk for developing cancer.
Questionnaire Data:
Your questionnaire data will be used for research purposes only. Your responses will not be shared with your personal doctor. If you feel you need a doctor's opinion about anything that is asked about in the questionnaire (such as mental or emotional difficulties or symptoms), please contact your personal physician.
About 1 month after each you complete the questionnaire each time, the research staff will review and score your responses. If your scores suggest signs of depression, you will be given a list of resources for mental health screening.
Length of Study:
After 5 years, your active participation in this study will be over. You may be contacted in the future to see if you would agree to take part in other research studies.
This is an investigational study.
Up to 1,501 people will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Windsor Village United Methodist Church | – | Behavioral: Questionnaire, Other: Body Measurements, Behavioral: Self-help MaterialsQuestionnaire + Body Measurements + Self-help Materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult attendees of Windsor Village United Methodist Church living in Houston.
Key inclusion criteria (4 listed)
- be age 18 years old and above
- read and write English
- live in the Houston metro area
- have a viable (working) telephone number and home address
Key exclusion criteria (1 listed)
- 1) None.
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 |
|---|---|---|
| QuestionnaireAlso: SurveyCompleted privately via computer at Windsor Village Church, approximately 75 minutes. Repeated at Months 12 and 24. | Behavioural | Windsor Village United Methodist Church |
| Body MeasurementsWaist, hip, height, and weight measured privately. Repeated at Months 12 and 24. | Other | Windsor Village United Methodist Church |
| Self-help MaterialsInformation on how to lower risk for developing cancer. | Behavioural | Windsor Village United Methodist Church |
Primary outcome
Feasibility Study Establishing African American Cancer Prevention Project (AACP)
Time frame: 2 Years
A longitudinal study to learn if and how certain behavioral, social, and environmental factors may affect cancer rates among African Americans as compared to other racial and ethnic groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Lorna H. McNeill, MPH, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by M.D. Anderson Cancer Center at 1 site 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Feasibility Study Establishing African American Cancer Prevention Project (AACP) (time frame: 2 Years). 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 27 Jan 2020.