Overview

This trial is active, not recruiting.

Condition tobacco use cessation
Treatments questionnaires, phone counseling, breath test, walking program, nicotine patch, audio recorded focus group
Sponsor M.D. Anderson Cancer Center
Start date January 2014
End date January 2018
Trial size 45 participants
Trial identifier NCT01915810, 2013-0183, NCI-2015-01057

Summary

The goal of this research study is to better understand if taking part in physical activity might help smokers quit.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Other)
Group 1 will not include any physical activity. Visits made to Windsor Village United Methodist Church 9 times on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking. During each visit questionnaires completed, along with a breath test to check for tobacco consumption. At 4 of the visits, height, weight, and waist and hip circumference measured. At 3 of these visits, heart rate also tested. Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day, and a 6-week supply of the nicotine patch. Accelerometer worn 3 weeks before quitting smoking through 4 weeks after the quit day. Participants take part in a final audio recorded focus group 8 weeks after quitting smoking.
questionnaires Surveys
Questionnaire completion on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
phone counseling
Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day.
breath test
Breath test administered to check for tobacco consumption weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
nicotine patch
6-week supply of the nicotine patch given to participants. Patch dosage congruent with pre-quit smoking rate and will taper over time.
audio recorded focus group
Participants take part in a final audio recorded focus group 8 weeks after quitting smoking.
(Active Comparator)
Group 2 starts a walking program 2 weeks before their quit day and finish it 2 weeks after their quit day. Visits made to Windsor Village United Methodist Church 9 times on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking. During each visit questionnaires completed, along with a breath test to check for tobacco consumption. At 4 of the visits, height, weight, and waist and hip circumference measured. At 3 of these visits, heart rate also tested. Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day, and a 6-week supply of the nicotine patch. Accelerometer worn 3 weeks before quitting smoking, through 4 weeks after the quit day. Participants take part in a final audio recorded focus group 8 weeks after quitting smoking.
questionnaires Surveys
Questionnaire completion on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
phone counseling
Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day.
breath test
Breath test administered to check for tobacco consumption weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
walking program
Group 2 start a walking program 2 weeks before their quit day and finish it 2 weeks after their quit day. Participants walk about 150 minutes (about 2 ½ hours) a week. Group 3 start a walking program on their quit day and finish it 4 weeks after their quit day. Participants walk about 150 minutes (about 2 ½ hours) a week.
nicotine patch
6-week supply of the nicotine patch given to participants. Patch dosage congruent with pre-quit smoking rate and will taper over time.
audio recorded focus group
Participants take part in a final audio recorded focus group 8 weeks after quitting smoking.
(Active Comparator)
Group 3 starts walking program on their quit day and finish it 4 weeks after their quit day. Visits made to Windsor Village United Methodist Church 9 times on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking. During each visit questionnaires completed, along with a breath test to check for tobacco consumption. At 4 of the visits, height, weight, and waist and hip circumference measured. At 3 of these visits, heart rate also tested. Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day, and a 6-week supply of the nicotine patch. Accelerometer worn 3 weeks before quitting smoking, through 4 weeks after the quit day. Participants take part in a final audio recorded focus group 8 weeks after quitting smoking.
questionnaires Surveys
Questionnaire completion on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
phone counseling
Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day.
breath test
Breath test administered to check for tobacco consumption weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
walking program
Group 2 start a walking program 2 weeks before their quit day and finish it 2 weeks after their quit day. Participants walk about 150 minutes (about 2 ½ hours) a week. Group 3 start a walking program on their quit day and finish it 4 weeks after their quit day. Participants walk about 150 minutes (about 2 ½ hours) a week.
nicotine patch
6-week supply of the nicotine patch given to participants. Patch dosage congruent with pre-quit smoking rate and will taper over time.

Primary Outcomes

Measure
Feasibility of Smoking Cessation with Physical Activity (SCwPA) Among African American (AA) Smokers
time frame: 11 weeks

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

Inclusion Criteria: 1. self-reported African-American race 2. age 21-65 3. current daily smoker (has smoked >=100 cigarettes in lifetime per self-report, smoked >=5 cigarettes per day for the last 6 months per self-report 4. self-reports motivation to quit smoking within the next 2 weeks 5. reports willingness to engage in a physical activity-based smoking cessation intervention 6. has a home address and a functioning home and/or cell phone number 7. able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner) if currently taking medication for blood pressure or diabetes. 8. willingness to wear the nicotine patches provided in the study as recommended 9. have an expired carbon monoxide (CO) level >/8 parts per million (ppm) suggestive of current smoking 10. blood pressure 140/90mm Hg. Exclusion Criteria: 1. contraindication for nicotine patch use 2. regular use of tobacco products other than cigarettes in the last 30 days (including black & milds) 3. current or planned future use of any nicotine replacement or pharmacological product for smoking cessation other than the study patches 4. pregnancy or lactation 5. another household member enrolled in the study 6. a schedule not accommodating to the study procedures, or unwillingness to adhere to the procedures

Additional Information

Official title Using Physical Activity to Facilitate Smoking Cessation Among African American Adults
Principal investigator Lorna H. McNeill, PHD, MPH
Description If you agree to take part in this study, you will visit the Windsor Village United Methodist Church 9 times. You will also receive help to quit smoking. You may or may not also be enrolled in an exercise program. Visits to the Windsor Village United Methodist Church: These visits will be 3, 2, and 1 week(s) before you quit smoking, on your quit day, and 1, 2, 3, 4, and 8 weeks after you quit smoking. Each visit may last about 1 hour to 1 ½ hours. During these visits: - You will complete questionnaires about your feelings, moods, smoking habits, and behaviors (such as physical activity). The questionnaires should take about 45 minutes total to complete. - You will complete a breath test. The breath test is used to find the amount of tobacco smoke that a person consumes. For this test, you will blow air through a tube into a measuring device. - At 3 of these visits, your heart rate will also be tested. For this test, you will put on a wrist watch and a belt band and sit quietly for 5 minutes while the equipment measures your heart rate. - At 4 of these visits, your height, weight, and waist and hip circumference will also be measured. To measure your waist and hip circumference, you may be asked to lift your shirt to expose your stomach area and lower your pants to expose your mid-hip area. Height, weight, and waist and hip circumference measurements take about 10 minutes and are performed in a private area. Quitting Smoking: You will receive help to quit smoking, including counseling about quitting smoking and a 6-week supply of the nicotine patch. The counseling will be over the phone about 1-2 weeks before your scheduled quit day. Study Groups for Physical Activity: In addition to the visits listed above, you will be randomly assigned (as in a roll of dice) to be in 1 of 3 groups. You will have an equal chance of being in any group. - Group 1 will not include any physical activity. - Group 2 will start a walking program 2 weeks before their quit day and finish it 2 weeks after their quit day. - Group 3 will start the walking program on their quit day and finish it 4 weeks after their quit day. All participants (Groups 1, 2, and 3) will wear an accelerometer for 5 weeks during the study. An accelerometer is a small device that you wear on a belt clip or an elastic belt near the hip during the day. It records how active you are. You will receive an accelerometer at your study visit 3 weeks before you quit smoking. You will wear it during the following times: - For 14 days in a row beginning 3 weeks before you quit smoking. - For 7 days beginning on the quit date. - For 7 days beginning on the visit 2 weeks following your quit date. - For 7 days beginning on the visit 4 weeks following your quit date. You should bring the accelerometer to each study visit so it can be recharged and the information can be downloaded. You will be given a prepaid envelope to return the accelerometer after the last recording. Physical Activity Groups 2 and 3: If you are in Group 2 or 3, you will take part in a walking program for 5 weeks. You will walk about 150 minutes (about 2 ½ hours) a week. You will receive a Walking Guide with instructions about how to do the exercises, which will also contain other tips for the walking program. Final Visit: All participants will take part in a final focus group. This focus group will take place sometime after the study visit 8 weeks after you quit smoking. This will take about 1 hour. You will be asked what you think about the program, including what you liked, did not like, and how you think it could be improved. If you want to provide this feedback but you cannot come to the focus group, you may provide feedback in another way (such as a phone interview or you could meet the study staff at the church). These focus groups/interviews will be audio recorded. Your name and identifying information will be deleted from the recording before being transcribed (typed out) by an outside party. Length of Study: You will be off study after the final focus group visit. Additional Information: Study staff may call you on your home and/or cell phone or contact you by e-mail to remind you about your study visits and/or to do your walking activity. If the accelerometer is lost or stolen, you will not be responsible for the replacement cost, but you should tell the study staff right away. If you do not come to the study visits listed above, researchers may call and ask about your smoking status. They may also schedule a visit to your home or office to take a breath sample. Your home address may be used to access public information about the area where you live. This is to help researchers learn about how your neighborhood encourages physical activity. The results from this study will only be reported as a group and you will not be identifiable from any products resulting from this study (such as research papers). Your home address will never be released or published in any form. Your address will be stored separately from other study data, and only the study chair will be able to see the data after the neighborhood information has been collected. Other Information: If the study staff thinks that any of your responses while on the study suggest signs of severe depression or show you are expressing suicidal ideation, a qualified member of the study staff will be contacted to review your risk of suicide. Based on that review, study staff will take steps to protect your safety, which can range from giving you a list of resources for mental health services to the contacting the police if they feel you are in immediate danger. Plan for Data Destruction: After the study is complete, the data are analyzed, and the manuscript/s are written, access to the de-identified data files will be limited to the study chair and research staff, who will keep the files on the MD Anderson computer server in case there are any questions about the data. Your data will be kept for 10 years after the study is completed but no later than 1/01/2025. After that time, data will be completely deleted. This is an investigational study. The nicotine patch used in this study is FDA approved and commercially available. Up to 45 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.