Automated Mobile Contingency Management for Smoking Cessation: A Pilot RCT (SCC PREVAILgo)

Study Overview
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Brief Summary
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The purpose of the proposed project is to pilot test an automated mobile phone-based contingency management (CM) approach to tobacco (smoking) cessation. With the assistance of the Mobile Health (mHealth) shared resource at the University of Oklahoma Health Sciences Center (OUHSC) and Stephenson Cancer Center (SCC), the investigators have combined technologies including 1) low-cost carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to confirm the identity of participants while they provide a breath sample, and 3) remote delivery of incentives automatically triggered by biochemical confirmation of self-reported smoking abstinence. This automated, mobile CM approach will be evaluated in a randomized controlled pilot trial of 40 socioeconomically disadvantaged males and females seeking smoking cessation treatment. Participants will be randomly assigned to telephone counseling plus nicotine replacement therapy (standard care [SC]) or SC plus a 12-week mobile financial incentives intervention (CM) for biochemically-confirmed abstinence. Participants will be followed for 12 weeks after a scheduled quit attempt to assess smoking status.

Detailed Description
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Tobacco Cessation Treatment. Participants referred to the Tobacco Treatment Research Program (TTRP) for smoking cessation treatment who are interested and eligible for the current study will be offered weekly telephone counseling/support sessions led by a staff counselor. Six unique sessions covering the following topics will be offered: 1) quit planning 2) the impact of tobacco on health/benefits of quitting, 2) stress management strategies, 3) making positive lifestyle changes, 4) developing coping skills, and 5) relapse prevention. The counselor will check in with participants each week about the difficulties and successes they have experienced, and plan for any challenging situations that are anticipated. Advice and support will be provided as needed. A two-week supply of nicotine replacement therapy (patches and gum) will be offered during the first session for medically eligible participants. Additional patches and gum will be mailed out for participants who wish to continue using pharmacotherapy (for up to 12 weeks). Financial Incentives. Participants will be provided with a smartphone that has the SCC PREVAILgo EMA app preloaded, as well as a Smokerlyzer iCO monitor. Participants will be randomly prompted 4 times daily during waking hours to complete smartphone-based EMAs (ecological momentary assessments). During random prompts, participants who self-report abstinence will be asked to provide a CO breath sample on 5 randomly selected days out of the week. Participants will be prompted to provide a CO breath sample at the last random assessment of the day, Participants will be reminded 2 additional times on the same day during their normal waking hours to provide a CO breath sample if they miss the initial assessment. A gift card credit may be earned following a self-report of abstinence during the past 24 hours combined with a breath CO sample of ≤ 6 ppm. Recruitment/Screening (Visit 1, Part 1; Screening). Individuals who are referred to the TTRP for smoking cessation treatment and report that they are uninsured or receiving Medicaid benefits will be sent an informational handout with their TTRP information packet (prior to their first visit). Participants will be reminded of all future in-person appointments via telephone, mail, email, and/or text. Additionally, research staff may attempt to collect smoking cessation status with each reminder. Participants with transportation difficulties living in the Oklahoma City metro area may be scheduled for pick-up and drop-off for key visits with SendaRide through their secure dashboard. At the first visit, study staff will inquire about their interest in finding out more about the study. Study staff will review the consent form with interested participants, and they 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 the TTRP. The Rapid Estimate of Adult Literacy in Medicine (REALM; see Appendix A) 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). Expired carbon monoxide (CO) will be measured and participants will be questioned about their 1) insurance status 2) age, 3) current level of smoking, 4) willingness to quit smoking, 5) willingness/ability to complete 6 weekly counseling sessions (including the first visit), 6) pregnancy/breastfeeding status, 7) computer/internet access, and 8) contraindications for nicotine replacement therapy. Expired CO will be measured. Eligible participants may complete the assessment portion of the visit. Pre-Quit (Visit 1, Part 2; Assessment). Participants will complete self-report questionnaires on a laptop computer; weight and height will be measured in a private room to ensure confidentiality. Visit 1 will be 1 of 2 in-person visits. Participants will be provided with an Android smartphone and a Smokerlyzer iCO breathe monitor. They will be instructed regarding the use of the phone (participants may make personal calls), the EMA procedures, and use of the portable CO monitor. Participants will receive 4 random prompts and 1 daily diary prompt (in the morning) during the normal waking hours each day for five consecutive weeks. Participants will be instructed to quit smoking at bedtime or 10:00 pm (whichever occurs first) 7 days after enrollment. Quit Day. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement. One Week Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement. Two Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement. Three Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement. Four Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement. Eight Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement. Twelve Weeks Post-Quit. Participants will return to the TTRP and complete self-report questionnaires on a tablet or laptop computer and provide a CO measurement.

Official Title
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Automated Mobile Contingency Management for Smoking Cessation: A Pilot RCT

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Mobile Contingency Management
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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annual Household income of < 200% of the federal poverty threshold (i.e., low-income) given household size earn a score ≥ 4 on the REALM indicating > 6th grade English literacy level are willing to quit smoking 7 days after enrollment are ≥ 18 years of age currently smoke ≥ 5 cigarettes per day have a CO level of > 6 ppm have no contraindications for NRT willingness to complete an identity check (i.e., video conference call or provide a photo ID).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Contingency Management<br> | Behavioral: Mobile Contingency Management<br>* Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.<br>Behavioral: Standard Care<br>* Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).<br>|
| Active Comparator: Standard Care<br> | Behavioral: Standard Care<br>* Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Smoking Cessation | Self-reported smoking abstinence during the past 7 days days | 13 weeks post-enrollment | 
| Completion of Breath Sample Submissions | The percentage of total possible smartphone-based breath sample submissions completed over 13 weeks. | 13 weeks post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of Smartphones | The total number of smartphones lost by participants during the study. | 13 weeks post-enrollment | 
| Loss of iCO Sensors | The total number of iCO Sensors lost by participants during the study. | 13 weeks post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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automated, smoking cessation, socioeconomic disadvantage, contingency management, financial incentives, mobile health, biochemical verification