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临床试验/NCT05645146
NCT05645146进行中(未招募)不适用

Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)

H. Lee Moffitt Cancer Center and Research Institute1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2022年11月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
360
试验地点
1
主要终点
MAPS vs Standard Treatment in facilitating long term smoking abstinence

研究概览

简要总结

The goal of this research study is to compare the efficacy of a treatment approach that comprises both Motivation And Problem-Solving (MAPS)-based telephone counseling and a personally-tailored SMS-delivered text-based approach to quitline-delivered smoking cessation treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.

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
Female
接受健康志愿者

入选标准

  • At least 100 cigarettes or more smoked in participants lifetime
  • Speaks English
  • Currently smoke 1 cigarette or more in the past 30 days
  • History of cervical cancer or high grade cervical dysplasia
  • Has a working smartphone
  • Has a valid home address
  • Reside in Florida at the time of study enrollment

排除标准

  • Receiving behavioral or pharmacological tobacco treatment
  • Household member enrolled in this study

研究组 & 干预措施

Group 1: Standard Treatment

Active Comparator

Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges)

干预措施: Smoking Cessation treatment delivered by Tobacco Free Florida Quitline (Behavioral)

Group 1: Standard Treatment

Active Comparator

Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges)

干预措施: Nicotine patch (Drug)

Group 1: Standard Treatment

Active Comparator

Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges)

干预措施: Nicotine Lozenge (Drug)

Group 2: Motivation and Problem Solving (MAPS) counseling

Experimental

Participants will receive a 12 week supply of nicotine replacement therapy (the patch and lozenges) along with the MAPS intervention, which consists of 6 MAPS counseling calls over 12 months, and individually tailored SMS text content driven by monthly smartphone delivered check-ins for 24 months

干预措施: Nicotine patch (Drug)

Group 2: Motivation and Problem Solving (MAPS) counseling

Experimental

Participants will receive a 12 week supply of nicotine replacement therapy (the patch and lozenges) along with the MAPS intervention, which consists of 6 MAPS counseling calls over 12 months, and individually tailored SMS text content driven by monthly smartphone delivered check-ins for 24 months

干预措施: Nicotine Lozenge (Drug)

Group 2: Motivation and Problem Solving (MAPS) counseling

Experimental

Participants will receive a 12 week supply of nicotine replacement therapy (the patch and lozenges) along with the MAPS intervention, which consists of 6 MAPS counseling calls over 12 months, and individually tailored SMS text content driven by monthly smartphone delivered check-ins for 24 months

干预措施: Motivation and Problem Solving (MAPS) intervention (Behavioral)

结局指标

主要结局

MAPS vs Standard Treatment in facilitating long term smoking abstinence

时间窗: at 24 months

The primary outcome of this study is self-reported, 7 day point prevalence abstinence over time through the 24 month assessment where participants who report no smoking in the previous 7 days at follow-up assessment are considered abstinent. Efficacy of MAPS vs Standard Treatment will be measured by comparing the number of participants in each group who were able to quit smoking and maintain smoking abstinence for 2 years.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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