Adjunctive Smart Phone Based Smoking Cessation Treatment

NCT03343249 | Completed DMC

• 2 other identifiers: SCCC-PSO1Z14STU 012014-012
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

Participants will be recruited for the current study during their initial orientation visit to the Parkland Health and Hospital System, Stop Smoking Class and Clinic every Monday morning. Individuals who are interested and eligible for participation in this study will receive uC (Parkland smoking cessation program), plus a tailored, adaptive, smart phone delivered smoking cessation intervention. Participants will be followed weekly from 1 week pre-quit through 4 weeks post-quit. all participants will be asked to attend 6 weekly visits, 4 of these visits will include a thorough assessment that may be completed either before or after their scheduled Parkland treatment appointments. All participants will receive a smartphone at the 1 week pre-quit visit and they will be asked to carry it with them at all times. Participants will complete eMa assessments 5 times per day (4 random assessments + 1 daily dairy) for three consecutive weeks. Geographic location coordinates will be captured during each eMa assessment to link characteristics of the neighborhood environment (e.g., neighborhood socioeconomic status, proximity to tobacco outlets) with cessation-related outcomes. Participants will be compensated upon the return of the smartphone at visit 4 (2 weeks post-quit). Participants will be asked to attend a follow-up visit 12 weeks after their quit date. At this visit, participants will complete additional questionnaires and their smoking status will be assessed. Expired carbon monoxide and weight will also be measured.

Conditions

High-Risk Cancer

Outcome Measures

Primary Outcomes (1)

• Smoking abstinence

  Evidence of abstinence from smoking confirmed by questionnaire.

  12 weeks

Study Arms (1)

Study Visits

EXPERIMENTAL

The Short form of the Rapid Estimate of Adult Literacy in Medicine (REALM) will be administered to ensure that all participants are able to read at \> sixth grade level. Expired carbon monoxide (CO) will be measured. Assessment: Participants will complete self-report questionnaires; and expired CO, weight, and height will be measured. Participants will be provided with a Samsung Galaxy Light Android smart phone and instructed on how to: 1) use the phone features, 2) complete EMAs, and 3) use the adjunctive Smart-T phone based treatment. Participants will receive 4 random prompts and 1 daily diary prompt during their normal waking hours each day for three consecutive weeks. Random assessments will take approximately 1 min to complete and daily diary assessments will take approximately 5 mins to complete.

Behavioral: Smart Phone Based Smoking Cessation

Interventions

Smart Phone Based Smoking Cessation BEHAVIORAL

The Samsung Galaxy Light Smart phone uses the Android 4.2 operating system. The phone has a 4.0 inch (480x800-pixel resolution) touch screen display, a built in microphone, earphone jack, audio speaker, and a rechargeable battery with 12.5 hours of talk time. The phone has 4G and is Wi-Fi and GPS capable. Participants navigate through the EMA program and enter data simply by touching the screen, similar to a pen-and-paper questionnaire. Thus, computer/typing skills are not required. Participants have the ability to call and receive calls from research staff through the smart phone free of charge. All phones will be equipped with Global Positioning Systems (GPS) capability. The smart phones are also equipped with a Secure Digital card to store data as it is collected.

Study Visits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be included in the study if they:
• earn a score greater than or equal to 4 on the Short REALM indicating greater than 6th grade English literacy level,
• are willing to quit smoking 7 days from their first visit,
• are greater than or equal to 18 years of age,
• have an expired CO level greater than or equal to 8 ppm suggestive of current smoking,
• are currently smoking greater than or equal to 5 cigarettes per day,
• are willing and able to attend 6 weekly sessions (i.e., week -1, quit day, week +1, week +2, week +3, week +4) and the 12 week follow-up session , and
• have not previously participated in Project PREVAIL \[STU 042011-096\] at Parkland Hospital. Please note that the Parkland smoking cessation program (usual care) is currently offered in English only.

You may not qualify if:

• Participants will be excluded from the study if they:
• are unwilling to quit smoking 7 days from their first visit,
• have already quit smoking,
• earn a score less than 4 on the Short REALM indicating less than or equal to 6th grade literacy level,
• produce an expired CO level less than 8 ppm,
• are currently smoking less than 5 cigarettes per day,
• are unwilling or unable to attend 7 assessment sessions,
• are less than 18 years of age, and/or
• have not previously participated in Project PREVAIL \[STU 042011-096\] at Parkland Hospital. Please note that the Parkland smoking cessation program (usual care) is currently offered in English only.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Officials

• Jennifer Gonzalez

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: November 17, 2017
• Study Start: June 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share