Physical Activity in Promoting Smoking Cessation in African Americans

NCT01915810 | Active Not Recruiting

• 2 other identifiers: 2013-0183NCI-2015-01057
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Current Smoker; Healthy Subject

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Mechanisms underlying smoking cessation (e.g., stress, positive and negative affect, depression, smoking urges, self-efficacy, motivation, PA enjoyment, and heart rate variability)

  Up to 8 weeks

Study Arms (3)

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.

Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling

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.

Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling

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.

Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling

Interventions

Exercise Intervention BEHAVIORAL

Complete SCwPA intervention

Arm I (pre-quit physical activity); Arm II (quit day physical activity)

Nicotine Patch DRUG

Receive nicotine patch

Also known as: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch

Arm I (pre-quit physical activity); Arm II (quit day physical activity); Arm III (no physical activity)

Questionnaire Administration OTHER

Ancillary studies

Arm I (pre-quit physical activity); Arm II (quit day physical activity); Arm III (no physical activity)

Tobacco Cessation Counseling OTHER

Receive smoking cessation counseling

Arm I (pre-quit physical activity); Arm II (quit day physical activity); Arm III (no physical activity)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (pre-quit physical activity); Arm II (quit day physical activity); Arm III (no physical activity)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported African-American race
• 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)
• Self-reports motivation to quit smoking within the next 2 weeks
• Reports willingness to engage in a physical activity-based smoking cessation intervention
• Has a home address and a functioning home and/or cell phone number
• 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
• Willingness to wear the nicotine patches provided in the study as recommended
• Have an expired carbon monoxide (CO) level \> 8 parts per million (ppm) suggestive of current smoking
• Blood pressure =\< 140/90mm or by physicians clearance (letter from physician or nurse practitioner) if blood pressure reading \> 140/90mm Hg

You may not qualify if:

• Contraindication for nicotine patch use
• Regular use of tobacco products other than cigarettes in the last 30 days (including black \& milds)
• Current or planned future use of any nicotine replacement or pharmacological product for smoking cessation other than the study patches
• Pregnancy or lactation
• Another household member enrolled in the study
• A schedule not accommodating to the study procedures, or unwillingness to adhere to the procedures

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Tobacco Use Cessation Devices; Nicotine

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lorna McNeill

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 5, 2013
• Study Start: January 29, 2014
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (1)