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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2022年11月29日

概览

阶段
不适用
干预措施
Smoking Cessation treatment delivered by Tobacco Free Florida Quitline
疾病 / 适应症
Smoking Cessation
发起方
H. Lee Moffitt Cancer Center and Research Institute
入组人数
360
试验地点
1
主要终点
MAPS vs Standard Treatment in facilitating long term smoking abstinence
状态
进行中(未招募)
最后更新
3个月前

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.

注册库
clinicaltrials.gov
开始日期
2022年11月29日
结束日期
2028年1月1日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

入排标准

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

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

Group 1: Standard Treatment

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

Group 1: Standard Treatment

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

Group 2: Motivation and Problem Solving (MAPS) counseling

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

Group 2: Motivation and Problem Solving (MAPS) counseling

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

Group 2: Motivation and Problem Solving (MAPS) counseling

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

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.

研究点 (1)

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