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Exercise Intervention for Smoking Cessation
N/A
Waitlist Available
Led By Lorna McNeill
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-reports motivation to quit smoking within the next 2 weeks
Be older than 18 years old
Must not have
A schedule not accommodating to the study procedures, or unwillingness to adhere to the procedures
Contraindication for nicotine patch use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether physical activity can help African Americans quit smoking.
Who is the study for?
This trial is for African American daily smokers who have smoked at least 100 cigarettes in their lifetime and are currently smoking more than five a day. They must be motivated to quit within two weeks, able to do moderate exercise, and willing to use nicotine patches provided by the study. People using other cessation aids or tobacco products, pregnant or lactating individuals, those with certain medical conditions or another household member in the study cannot join.
What is being tested?
The trial is testing if physical activity can help African Americans quit smoking when combined with nicotine patches, counseling, and monitoring through questionnaires and lab tests. Participants will be randomly assigned to either start exercising as part of their quitting process or not.
What are the potential side effects?
Possible side effects may include skin irritation from nicotine patches and typical risks associated with moderate exercise such as muscle strain. The intensity of these side effects can vary among participants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am motivated to quit smoking in the next 2 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am willing and able to follow the study's schedule and procedures.
Select...
I cannot use nicotine patches due to health reasons.
Select...
I am using or plan to use a smoking cessation aid that is not provided by the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post intervention focus group analysis
Secondary study objectives
Mechanisms underlying smoking cessation (e.g., stress, positive and negative affect, depression, smoking urges, self-efficacy, motivation, PA enjoyment, and heart rate variability)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (quit day physical activity)Experimental Treatment5 Interventions
Participants receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. Beginning on the assigned quit date, participants receive a Walking Program guide and engage in the SCwPA comprising brisk, self-paced walking with a goal of 150 minutes of exercise per week for 5 weeks.
Group II: Arm I (pre-quit physical activity)Experimental Treatment5 Interventions
Participants receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. Beginning 2 weeks before the assigned quit date, participants receive a Walking Program guide and engage in the SCwPA comprising brisk, self-paced walking with a goal of 150 minutes of exercise activity per week for 5 weeks.
Group III: Arm III (no physical activity)Active Control4 Interventions
Participants quit smoking on an assigned date and receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2016
Completed Phase 4
~1330
Nicotine Patch
2011
Completed Phase 4
~10480
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,782 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,192 Total Patients Enrolled
2 Trials studying Smokers
1,250 Patients Enrolled for Smokers
Lorna McNeillPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
1,600 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's schedule and procedures.I am willing to wear nicotine patches as the study requires.I cannot use nicotine patches due to health reasons.I am motivated to quit smoking in the next 2 weeks.I can do moderate exercise, as confirmed by a questionnaire or my doctor.I am using or plan to use a smoking cessation aid that is not provided by the study.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (quit day physical activity)
- Group 2: Arm I (pre-quit physical activity)
- Group 3: Arm III (no physical activity)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Smokers Patient Testimony for trial: Trial Name: NCT01915810 — N/A