Clinical trial NCT03405129: Project Phoenix: Pilot Intervention for Smokers Who Are Not Ready to Quit Smoking
Official title: Project Phoenix: Pilot Intervention for Smokers Who Are Not Ready to Quit Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Motivation
Keywords: Smoking Cessation
Smartphone App
Dynamic Treatment
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Description of Study Visit and Follow-Up:

Screening and Baseline Assessment Visit. Individuals who complete the online screener (i.e., REDCap) and meet initial study inclusion criteria will be invited to complete the in person screener and baseline visit at the Tobacco Treatment Research Program (TTRP). Potential participants will be provided with detailed information about the study and given the opportunity to have their questions answered within a private room to ensure confidentiality. Study staff will review the consent form with interested participants, who will be screened for eligibility on-site in a private room in the clinic. Participant eligibility for the current study will not influence eligibility for treatment at the TTRP. The Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM45) will be administered to ensure that all participants are able to read at \> sixth grade level (i.e., required to complete EMA and self-report questionnaires). Participants will also be asked to read aloud from the Informed Consent form. Expired carbon monoxide (CO) will be measured with a Vitalograph BreathCO carbon monoxide monitor and a Bedfont iCO carbon monoxide monitor. The purpose of using both monitors is to validate the Bedfont iCO device. Participants will be questioned in person to verify the information they provided during the REDCap screening process. Race/ethnicity, sex, cigarettes smoked per day, education, and readiness to quit smoking will be used to randomize participants to the Phoenix, Phoenix + NRT, or Factoid groups using adaptive randomization software. Participants will complete the assessment portion of the baseline visit on a laptop/tablet computer; and weight, and height will be measured in a private room to ensure confidentiality.

Participants will be instructed that the app will prompt and deliver two messages per day and that they should click the "Set New Quit Date" button when/if they want to set a smoking cessation quit date. They will be informed that the app will offer smoking cessation resources after they set a quit date.

Week 26 Follow-Up Phone Call. All participants will be asked to complete a brief 10-15 minute follow-up interview over the phone. Participants will be asked about their current smoking status, their opinions about the smartphone app, and how the app could be improved for future studies.

Eligibility criteria: Inclusion Criteria:

1. are ≥ 18 years of age
2. demonstrate \> 6th grade English literacy level
3. possess an active Android smartphone with a data plan and an operating system version 5.2 or higher
4. agree to install the study smartphone application onto their personal phone
5. agree to complete 26 weekly assessments prompted by and completed through the study smartphone application
6. score \>1 and \<7 on the Readiness to Quit Ladder
7. have an expired carbon monoxide (CO) level \> 7 ppm suggestive of current smoking
8. currently smoke ≥ 5 cigarettes per day
9. 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)

Exclusion Criteria:

1. cannot read, speak, and understand English
2. are \< 18 years of age
3. plan to quit smoking within the next 30 days

Primary outcomes:
measure: Days of smoking abstinence
timeFrame: 26 weeks
Secondary outcomes:
measure: Number of days to the first smoking cessation attempt
timeFrame: 26 weeks
measure: Medication use
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center - OTRC
state: Oklahoma
Study officials:
References: