Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods
| Registry | NCT00948129 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 626 (Actual) |
| Sponsor | M.D. Anderson Cancer Center (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | Cigarette Smoker, Current Every Day Smoker |
| Interventions | Laboratory Biomarker Analysis, Smoking Cessation Intervention, Telephone-Based Intervention, Tobacco Cessation Counseling (Other, behavioral) |
| Dates | start 2009-08-10, primary completion 2021-02-10, completion 2021-02-10, first posted 2009-07-29, last updated 2023-01-20 |
| Locations | 1 site in United States |
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This trial studies how well a mobile smoking cessation intervention works in enhancing cancer outreach in low-income adult smokers. Mobile smoking cessation intervention may help smokers quit or cut back on smoking, and help increase the range of cancer prevention services provided to low-income adult smokers.
PRIMARY OBJECTIVES:
I. Compare the efficacy of three smoking cessation interventions targeting community based low-income uninsured and underinsured individuals in a group-randomized trial.
II. Evaluate the role of quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect as potential mediators of smoking abstinence.
III. Compare the cost-effectiveness of the three treatment conditions.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I (STANDARD CARE): Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials.
GROUP II (ENHANCED CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks.
GROUP III (INTENSIVE CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks.
After completion of study, participants are followed up at 3, 6, and 12 months.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group I (standard care) | Active comparator | Other: Laboratory Biomarker Analysis; Behavioral: Smoking Cessation Intervention | Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials. |
| Group II (enhanced care) | Experimental | Other: Laboratory Biomarker Analysis; Behavioral: Smoking Cessation Intervention; Other: Tobacco Cessation Counseling | Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks. |
| Group III (intensive care) | Experimental | Other: Laboratory Biomarker Analysis; Behavioral: Smoking Cessation Intervention; Behavioral: Telephone-Based Intervention; Other: Tobacco Cessation Counseling | Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Smoked at least 100 cigarettes in lifetime * English or Spanish speaking * Currently smoking at least 5 cigarettes a day, on average * Willing to set a quit smoking date within a week of the enrollment Exclusion Criteria: * Positive history of a medical condition that precludes use of the nicotine patch * Current use of nicotine replacement therapy (NRT) * Current use of other smoking cessation medications (e.g., Chantix or Zyban) * Pregnant or nursing * Enrolled in another smoking cessation study
| Facility | City | Country | Status |
|---|---|---|---|
| M D Anderson Cancer Center | Houston, Texas | United States |
NIH grants: R01CA141628