PASCAL Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: chatbot, no chatbot.
- Who it may be relevant to
- Registry conditions: Smoking Cessation, Smoking (Tobacco) Addiction. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility of Using a Conversational Agent for Promoting Smoking Cessation Treatment Utilization
Overview
The goal of this randomized study is to assess if a conversational agent (or chatbot) that the investigators have developed to help with quitting smoking is acceptable to people trying to quit smoking and to also collect initial information regarding its effectiveness. In this study, some participants trying to quit smoking will be provided with this chatbot while other participants will not be
Interventions
- Other chatbot
a chatbot will alert during predicted high risk smoking times and suggest approaches to manage potential smoking triggers - Other no chatbot
no chatbot is provided
Primary outcome measures
- Feasibility of trial procedures [Time frame: 1 day]
- Feasibility of study procedures [Time frame: 2 weeks]
- Health Information Technology Usability Evaluation Scale (Health-ITUES) [Time frame: 2 weeks]
Secondary outcome measures (11)
- Average number of daily interactions with the study app [Time frame: 2 weeks]
- The average number of cigarettes smoked per day [Time frame: 2 weeks]
- Average number of nicotine lozenges used [Time frame: 2 weeks]
- The proportion of participants who complete the week 8 post-quit visit [Time frame: 8 weeks]
- The proportion of participants not smoking for the 7 day period before the week 2 visit [Time frame: 2 weeks]
- The proportion of participants not smoking for the 7 day period before the week 8 visits [Time frame: 8 weeks]
- The proportion of participants not smoking at all between the quit date and the week 2 visit [Time frame: 2 weeks]
- The proportion of participants not smoking at all between the quit date and the week 8 visit [Time frame: 8 weeks]
- Motivation to quit smoking [Time frame: 2 weeks]
- Brief Questionnaire of Smoking Urges (QSU-Brief) [Time frame: 2 weeks]
- The Minnesota Nicotine Withdrawal Scale (MNWS) [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- Identify as Black or African American
- Be at least 21 years of age
- Meet a minimum smoking amount
- Be willing to make a quit attempt in the next 30 days
- Have a smartphone capable of downloading and running the study app
- Be able to upload data from the app
- Agree to receive text message reminders about study activities
- Be a native English speaker
- Reside in Minnesota.
Exclusion criteria
- Medicinal nicotine use would require careful monitoring by a healthcare professional
- Medical condition or medication used likely to significantly interfere with study outcomes or to be significantly affected by changes in smoking behavior
- Are pregnant or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT07301151 · STUDY00026782 · P50MD017342