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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01057 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2013-0183 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
This randomized pilot clinical trial studies the use of physical activity in promoting the discontinuation of the habit of smoking (smoking cessation) in African Americans. Participating in physical activity during an actual smoking quit attempt may work better in helping African Americans stop smoking.
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of a Smoking Cessation with Physical Activity (SCwPA) intervention among an African American (AA) church-based sample of adult current smokers.
II. Conduct post-intervention focus groups to obtain feedback from pilot participants regarding the acceptability of the SCwPA project design and procedures.
III. Examine how physical activity (PA) and the timing of PA initiation affects the mechanisms underlying cessation among an AA church-based sample of adult daily smokers who are attempting to quit.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I (PRE-QUIT PHYSICAL ACTIVITY): 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.
ARM II (QUIT DAY PHYSICAL ACTIVITY): 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.
ARM III (NO PHYSICAL ACTIVITY): 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (pre-quit physical activity) | Experimental | 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. |
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| Arm II (quit day physical activity) | Experimental | 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. |
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| Arm III (no physical activity) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Complete SCwPA intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment feasibility, defined as >= 75% of eligible/screened participants choose to enroll in the study | Up to 8 weeks | |
| Retention feasibility, defined as an overall retention rate of 80% and if each enrolled participant completes >= 66.7% of study visits (>= 6 of 9 study visits) | Up to 8 weeks | |
| Post intervention focus group analysis | Each focus group will use a semi-structured interview guide for consistency, which will consist of approximately 15 open-ended questions. If results do not suggest intervention feasibility, post-intervention focus groups will help to identify why feasibility was not achieved. Focus group transcripts will be imported into a qualitative data analysis software program, such as NVivo, to facilitate data retrieval and analysis and to organize data by themes based on phrases, patterns, relationships, and commonalties or disparities. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanisms underlying smoking cessation (e.g., stress, positive and negative affect, depression, smoking urges, self-efficacy, motivation, PA enjoyment, and heart rate variability) | Validated questionnaires via associated scoring manuals or by convention in the literature will be scored. Descriptive statistics, including mean and variance estimates with 95% confidence intervals, relevant to each of the identified mechanism variables, for each intervention group will be generated. Group*time effects with regard to stress, positive and negative affect, depression, smoking urges, self-efficacy, motivation, and heart rate variability will be examined using repeated measure analyses of variance as the primary analysis technique. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorna McNeill | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Nicotine Patch | Drug | Receive nicotine patch |
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| Questionnaire Administration | Other | Ancillary studies |
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| Tobacco Cessation Counseling | Other | Receive smoking cessation counseling |
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| Up to 8 weeks |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |