Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 626
- 试验地点
- 1
- 主要终点
- Smoking abstinence rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group I (standard care)
Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials.
干预措施: Laboratory Biomarker Analysis (Other)
Group I (standard care)
Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials.
干预措施: Smoking Cessation Intervention (Behavioral)
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.
干预措施: Laboratory Biomarker Analysis (Other)
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.
干预措施: Smoking Cessation Intervention (Behavioral)
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.
干预措施: Tobacco Cessation Counseling (Other)
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.
干预措施: Laboratory Biomarker Analysis (Other)
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.
干预措施: Smoking Cessation Intervention (Behavioral)
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.
干预措施: Telephone-Based Intervention (Behavioral)
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.
干预措施: Tobacco Cessation Counseling (Other)
结局指标
主要结局
Smoking abstinence rate
时间窗: At 12 months
The primary method of analysis will be mixed-model logistic regression.
Cost-effectiveness
时间窗: At 12 months
Will perform an incremental cost-effectiveness analysis by comparing the expected economic costs and clinical benefits of the three strategies. Will create a decision-analytic model using TreeAge Pro 2007 software to conduct the incremental cost-effectiveness analysis.
次要结局
- Salivary cotinine levels(At 12 months)