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临床试验/NCT04194918
NCT04194918已完成1 期

A Scalable E-Health Smoking Cessation Intervention for Sexual and Gender Minority Young Adults

Fred Hutchinson Cancer Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年5月18日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
25
试验地点
1
主要终点
Treatment utilization

研究概览

简要总结

This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of developing tobacco-related health conditions.

详细描述

OUTLINE:

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

Participants are followed up with at 2 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participants must self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth)
  • •Participants must currently reside in the United States and anticipate remaining in the United States for the duration of the study (2 months)
  • •Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
  • •Participants must self-report having at least weekly internet access for the next two months
  • •Participants must self-report being willing and able to stream video online for this study
  • •Participants must self-report current use of a personal email account
  • •Participants must self-report current use of text messaging
  • •Participants must self-report that they are interested in participating in the study for themselves (versus [vs] someone else)
  • •Participants must self-report that they are not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
  • •Participants must self-report that they have not participated in one of our prior smoking cessation studies, including the user-centered research conducted in the development of Flexiquit+
  • •Participants must self-report that they are comfortable reading, writing, and speaking English
  • •Participants must self-report that they understand and agree to the conditions of compensation
  • •Participants must self-report that they are not currently incarcerated in a prison
  • •Participants must be willing to use the Flexiquit+ program, complete the study assessments, and sign an online consent form

排除标准

  • 未提供

研究组 & 干预措施

Prevention (Flexiquit+, text message, handout)

Experimental

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

干预措施: Computer-Assisted Smoking Cessation Intervention (Behavioral)

Prevention (Flexiquit+, text message, handout)

Experimental

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

干预措施: Text Message (Other)

Prevention (Flexiquit+, text message, handout)

Experimental

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

干预措施: Handout (Other)

Prevention (Flexiquit+, text message, handout)

Experimental

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

干预措施: Questionnaire Administration (Other)

Prevention (Flexiquit+, text message, handout)

Experimental

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

干预措施: Quality-of-Life Assessment (Other)

Prevention (Flexiquit+, text message, handout)

Experimental

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

干预措施: Survey Administration (Other)

结局指标

主要结局

Treatment utilization

时间窗: Enrollment up to 2 months

Will be determined by the server-recorded number of logins and the number of sessions completed. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Tables with N (%) or mean (standard deviation) by treatment arm will be provided.

Treatment satisfaction: survey

时间窗: Enrollment up to 2 months

Will be determined using 12 items on the 2-month outcome survey. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Categorical ratings for treatment satisfaction questions will be dichotomized as "somewhat", "mostly", or "very" useful versus (vs.) lower ratings. Tables with N (%) or mean (standard deviation) by treatment arm will be provided.

次要结局

  • Smoking cessation rate(At 2 months post-enrollment)
  • Change in motivation to quit smoking(From baseline to 2-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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