Project Phoenix: Pilot Intervention for Smokers Who Are Not Ready to Quit Smoking
Phoenix
1 other identifier
interventional
152
1 country
1
Brief Summary
Smoking is the leading preventable cause of death and disease in the United States. Although most smokers report that they would like to quit smoking at some point in the future, only 20% are ready to quit within the next 30 days. Importantly, studies have indicated that interventions can increase motivation and/or readiness for cessation among smokers who are not yet ready to quit and these types of intervention can increase smoking cessation attempts. Smartphone apps that offer daily information about the benefits of quitting and motivational/supportive messages that aim to increase cessation self-efficacy may increase the likelihood of initiating a smoking cessation attempt. Previous research has indicated that smoking cessation smartphone applications are feasible and well-liked by smokers who are already committed to quitting smoking. However, there are no empirically supported smartphone apps that provide dynamic smoking cessation content that is automatically matched to a smoker's current readiness to quit. This type of dynamically tailored intervention could overcome many of the barriers that have hampered the widespread use of traditional empirically supported smoking cessation treatments. The current pilot study (N=150) is a 3-armed randomized controlled smoking cessation induction trial that will determine the initial utility of a novel smartphone based intervention compared with an attention control group among smokers who are not yet ready to quit. The two intervention groups (Group 1: Phoenix App Only; Group 2: Phoenix App + Nicotine Replacement Therapy \[NRT\]) will receive targeted smoking cessation messaging that is matched to a participant's readiness to quit, while the attention control group (i.e., Factoid) will receive messages that are not related to smoking cessation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2017
CompletedFirst Posted
Study publicly available on registry
January 19, 2018
CompletedStudy Start
First participant enrolled
October 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2022
CompletedMay 11, 2023
May 1, 2023
3.6 years
December 22, 2017
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days of smoking abstinence
Total number of days of self-reported smoking abstinence
26 weeks
Secondary Outcomes (2)
Number of days to the first smoking cessation attempt
26 weeks
Medication use
26 weeks
Study Arms (3)
Factoid Group
ACTIVE COMPARATORThe Factoid group will receive a smartphone app that delivers 2 factual messages per day
Phoenix Group
EXPERIMENTALThe Phoenix group will receive a smartphone app that includes multiple components that vary based upon the participant's smoking cessation stage
Phoenix + NRT Group
EXPERIMENTALThe Phoenix + (Nicotine Replacement Therapy) NRT group will receive a smartphone app that is identical to the Phoenix group, with one additional feature. Participants will be able to click an "Order Nicotine Patches and Gum" button to order NRT.
Interventions
Eligibility Criteria
You may qualify if:
- are ≥ 18 years of age
- demonstrate \> 6th grade English literacy level
- possess an active Android smartphone with a data plan and an operating system version 5.2 or higher
- agree to install the study smartphone application onto their personal phone
- agree to complete 26 weekly assessments prompted by and completed through the study smartphone application
- score \>1 and \<7 on the Readiness to Quit Ladder
- have an expired carbon monoxide (CO) level \> 7 ppm suggestive of current smoking
- currently smoke ≥ 5 cigarettes per day
- have no contraindications for over the counter NRT (i.e., individuals with uncontrolled blood pressure, history of myocardial infarction within the past two weeks, or current pregnancy or plans to become pregnant during the study period will be excluded)
You may not qualify if:
- cannot read, speak, and understand English
- are \< 18 years of age
- plan to quit smoking within the next 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma Health Sciences Center - OTRC
Oklahoma City, Oklahoma, 73104, United States
Related Publications (2)
Ulm C, Chen S, Fleshman B, Benson L, Kendzor DE, Frank-Pearce S, Neil JM, Vidrine D, Businelle MS, De La Torre I. Smartphone-Based Survey and Message Compliance in Adults Initially Unready to Quit Smoking: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2024 Jun 7;8:e56003. doi: 10.2196/56003.
PMID: 38848557DERIVEDBusinelle MS, Benson L, Hebert ET, Neil J, Kendzor DE, Frank-Pearce S, Kezbers KM, Vidrine D, Gaur A. Project phoenix: Pilot randomized controlled trial of a smartphone-delivered intervention for people who are not ready to quit smoking. Drug Alcohol Depend. 2024 Jul 1;260:111351. doi: 10.1016/j.drugalcdep.2024.111351. Epub 2024 May 31.
PMID: 38838477DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2017
First Posted
January 19, 2018
Study Start
October 17, 2018
Primary Completion
May 18, 2022
Study Completion
May 18, 2022
Last Updated
May 11, 2023
Record last verified: 2023-05