Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03739437 |
| Other study ID # |
9717 |
| Secondary ID |
P30CA225520 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 10, 2020 |
| Est. completion date |
May 3, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
University of Oklahoma |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
