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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00029 | Registry Identifier | NCI CTRP | |
| 5U54CA153505 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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The goal of this research study is to learn if a wellness program can help improve diet and physical activity levels and encourage smoking cessation in Latino individuals who are overweight.
Day 1 Study Visit:
If you are found eligible to take part in this study, the following tests and procedures will be performed on Day 1 (the same day you complete the screening tests and sign this consent form):
Study Groups and Study Procedures:
At the Day 1 study visit, you will be randomly assigned (as in the flip of a coin) into 1 of 2 study groups. There is an equal chance of being assigned to either group.
Participants in both groups will receive health education on Day 1, and again 6 and 12 months later. You can also ask to receive a 6-week supply of nicotine patches, whenever you are ready to try to quit smoking and a home-based exercise kit when you are ready to begin an exercise program.
At the Day 1 health education session, the following will take place:
At the Months 6 and 12 health education sessions, the Day 1 activities will be repeated, and the following procedures will also take place:
You will also have a follow-up study visit at Month 18. During this visit, the same procedures from the Month 12 visit will be performed. However, you will not have a health education session at Month 18.
Wellness Program:
In addition to the health education visits and materials, participants in Group 2 will also take part in the wellness program. For the wellness program, you will receive 18 counseling phone calls over the 18 months you are on study. Each of these phone calls should last about 20-30 minutes.
The telephone counseling sessions will be digitally recorded. Audio recordings will be erased once the data have been published. The recordings will be used to help the researchers make sure that the counselors are following the correct procedures and may be used in the future to help the researchers better understand or improve the counseling treatment. No one but the researchers and their staff will be allowed to view or listen to the recordings, and the identity of the participants will be kept strictly confidential. Your study identification number will be stated by the counselor at the beginning of the taped session. The recordings are stored digitally, encrypted, and password protected.
Questionnaire Data:
Your questionnaire data will be used for research purposes only. Your responses will not be shared with your doctor. If you feel you need a doctor's opinion about anything that is asked about in the questionnaires (such as mental or emotional difficulties or symptoms), please contact either your personal doctor or the study chair.
Length of Study:
You will remain on the study for up to 18 months. Your participation on this part of the study will be over once you complete the study visit at Month 18.
Other Important Information:
This is an investigational study. The nicotine patch is FDA approved and commercially available. Up to 500 participants overall will take part in this research study. Up to 400 participants will take part in this portion of the study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Education (HE) | Experimental | HE of brief counseling and self-help materials addressing 3 risk behaviors, referrals to available resources, and a home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed. |
|
| Motivation and Problem Solving (MAPS) | Experimental | HE counseling, self-help materials, and resource referrals, and home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed. Plus 9 proactive, telephone counseling sessions over the 18 month period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education | Behavioral | Brief counseling at baseline, at 6 months and again at 12 months, and self-help materials addressing smoking cessation, diet, physical activity, referrals to available resources, and a home-based exercise kit (e.g., pedometer, exercise ball, strength training cables). |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction | Generalized linear mixed model regression (GLMM) used in analyzing the effects of motivation and problem solving (MAPS) on the primary outcomes across the 6, 12, and 18-month time points. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Basen-Engquist, PHD, BA, MPH | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Marsh Rice University | Houston | Texas | 77005 | United States | ||
| University of Texas MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23506397 | Derived | Castro Y, Basen-Engquist K, Fernandez ME, Strong LL, Eakin EG, Resnicow K, Li Y, Wetter DW. Design of a randomized controlled trial for multiple cancer risk behaviors among Spanish-speaking Mexican-origin smokers. BMC Public Health. 2013 Mar 18;13:237. doi: 10.1186/1471-2458-13-237. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D003376 | Counseling |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| Questionnaires | Behavioral | Computer-based questionnaires completed at baseline, then every 6 months taking 60-90 minutes to complete. |
|
|
| Telephone Counseling Sessions | Behavioral | 9 proactive, telephone counseling sessions over 18 months. Each of these phone calls should last about 20-30 minutes. |
|
|
| Nicotine Patches | Drug | 6-week supply of nicotine patches given to participants ready to quit smoking. |
|
| Houston |
| Texas |
| 77030 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D013812 | Therapeutics |