Project Phoenix: Pilot Intervention for Smokers Who Are Not Ready to Quit Smoking

NCT ID: NCT03405129

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-17
• Study Completion Date: 2022-05-18

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.

Conditions

Smoking Cessation; Motivation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Factoid Group

The Factoid group will receive a smartphone app that delivers 2 factual messages per day

Group Type: ACTIVE_COMPARATOR

Factoid

Intervention Type: BEHAVIORAL

Factoid app

Phoenix Group

The Phoenix group will receive a smartphone app that includes multiple components that vary based upon the participant's smoking cessation stage

Group Type: EXPERIMENTAL

Phoenix

Intervention Type: BEHAVIORAL

Phoenix cessation app

Phoenix + NRT Group

The 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.

Group Type: EXPERIMENTAL

Phoenix

Intervention Type: BEHAVIORAL

Phoenix cessation app

NRT order button

Intervention Type: BEHAVIORAL

Ability to order NRT through smartphone app

Interventions

Phoenix

Phoenix cessation app

Intervention Type: BEHAVIORAL

NRT order button

Ability to order NRT through smartphone app

Intervention Type: BEHAVIORAL

Factoid

Factoid app

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Oklahoma Health Sciences Center - OTRC

Oklahoma City, Oklahoma, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38848557 (View on PubMed)

Businelle 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.

Reference Type: DERIVED

PMID: 38838477 (View on PubMed)

Other Identifiers

8814

Identifier Type: -

Identifier Source: org_study_id