Determinants of Multiple Health Risk Behaviors Among Latinos

NCT ID: NCT01479257

Last Updated: 2019-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this research study is to learn how cultural, environmental, and interpersonal experiences, as well as personal thoughts and feelings, influence cancer risk behaviors among Latino residents of Houston, Texas.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study Participation:

If you are eligible and choose to take part in this study, you can choose to visit the clinic 2 times or have research staff visit you in your home or a community setting (such as a church or community center) 2 times.

At the first visit (this is the same visit where you complete the in-person screening test):

* You will have your height, weight, and waistline measured.
* You will be given a smart phone to take home with you. You will answer questions on the smart phone up to 5 times a day for 7 days. The phone will beep at random times (4 times per day) and set times (in the evening) to prompt you to answer questions about what you are doing and your current thoughts and feelings. These questions should take about 5-7 minutes to complete each time.
* You will be given an accelerometer (a movement meter). The accelerometer is a small device worn on your hip that measures the amount of physical activity you do. You will wear the accelerometer for 7 days in a row.
* You will receive training on how to use the smart phone and the accelerometer.

At the second visit, you will return the smart phone and the accelerometer.

At both study visits, you will be asked to complete questionnaires that ask about your feelings, moods, and behaviors. You will complete 36 questionnaires at the first visit (a total of 474 questions) and 25 questionnaires at the second visit (a total of 278 questions). These questionnaires should take about 60 to 90 minutes to complete.

Throughout the study, you will be contacted by mail, email, or telephone for reminders of visits. You will be reminded before each visit. You will be asked to provide the names and contact information for family and/or friends should the study staff have trouble reaching you.

Confidentiality:

Each time you complete a survey on the smart phone, your answers will be saved on the phone. When you return the phone, all of your answers will be downloaded from the phone to a secure server, where they will be stored. Then, all of your information will be deleted from the phone. Your name or other personal information will not be stored on the phone.

Your name and other identifying information will not be stored together in the same files as other information you provide during your participation in the study. The link between your identifying information and other data will be kept in a separate file and securely protected. The link between you and the study data will be destroyed 5 years after the study ends.

Length of Study:

You will be considered off study when you complete the second visit.

This is an investigational study.

Up to 225 participants will take part in this study. All will be enrolled at MD Anderson.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Risk Factors in Latinos

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bilingual Latinos

Bilingual Houston area Latinos surveyed for 7 continuous days with objective and subjective assessments using accelerometer and smart phone.

Questionnaires

Intervention Type BEHAVIORAL

36 questionnaires at the first visit (a total of 474 questions) and 25 questionnaires at the second visit (a total of 278 questions), taking about 60 to 90 minutes to complete each visit.

Accelerometer

Intervention Type DEVICE

Small device worn on the hip for 7 consecutive days that measures physical activity.

Smart Phone

Intervention Type DEVICE

Questions on smart phone up to 5 times a day for 7 days taking about 5-7 minutes to complete each time.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaires

36 questionnaires at the first visit (a total of 474 questions) and 25 questionnaires at the second visit (a total of 278 questions), taking about 60 to 90 minutes to complete each visit.

Intervention Type BEHAVIORAL

Accelerometer

Small device worn on the hip for 7 consecutive days that measures physical activity.

Intervention Type DEVICE

Smart Phone

Questions on smart phone up to 5 times a day for 7 days taking about 5-7 minutes to complete each time.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Surveys Movement meter cell phone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Self-identify as Latino in ethnicity
2. Are between the ages of 18-65, inclusive
3. Possess a valid home address and functioning telephone number
4. Possess marginal to adequate health literacy in English (as indicated by a score of at least 45 on the Rapid Estimate of Adult Literacy in Medicine) and Spanish (as indicated by a score of at least 38 on the Short Assessment of Health Literacy for Spanish Adults).

Exclusion Criteria

1. Used an illicit substance in the past 30 days
2. Another household member enrolled in the study
3. Pregnant or breastfeeding
4. Participated in a smoking cessation program in the last 90 days
5. Uses nicotine replacement products
6. Uses other tobacco products besides cigarettes
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Larkin L. Strong, PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1K01CA157689

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R25T CA57730

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011-0696

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.