Cigarette Smoking-Related Carcinoma
Conditions
Brief summary
This phase III trial compares a smartphone application with or without nicotine replacement therapy in improving smoking cessation among Hispanic adults who would like to quit smoking. The iCanQuit smartphone application focuses on skills for managing urges, motivation, and relapse prevention with personalized quit plans. Nicotine replacement therapy works by giving small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking without any of the other harmful chemicals found in tobacco products.
Detailed description
OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. ARM II: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum or lozenges to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months. After completion of study intervention, patients may be followed up at 12 months.
Interventions
DEVICEiCanQuit Smartphone App Smoking Cessation Program
Receive access to iCanQuit app, with daily push notifications
DRUGNicotine Gum
Receive nicotine replacement therapy gum
DRUGNicotine Patch
Receive nicotine replacement therapy patch(es)
DRUGNicotine Lozenge
Receive nicotine replacement therapy lozenge(s)
OTHERSurvey Administration
Ancillary studies
OTHERInterview
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
To assure blinding, random assignments will be concealed from participants and researchers throughout the trial. Follow-up data will be collected by our survey research unit that will be blind to treatment arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Self-identify as Hispanic ethnicity * Age 18 and older * Smoking at least one cigarette per day in the past 30 days * Want to quit smoking within 30 days * Interest in learning skills to quit smoking * Willing to be randomly assigned * United States (US) or Puerto Rico (PR) residency for the next twelve months * Have daily access to their own Android or iPhone smartphone * Ability to download a smartphone application (app) * Proficiency in English or Spanish * Not currently (i.e., within past 30 days) using other smoking cessation interventions * Willing to consider using NRT * No previous use of iCanQuit * No household or family member participating * Willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups * Providing email, phone number(s), and mailing address
Exclusion criteria
* NRT CONTRAINDICATION: Heart attack in the last 2 months * NRT CONTRAINDICATION: Stroke in the last 6 months * NRT CONTRAINDICATION: Diagnosed arrhythmia or tachycardia * NRT CONTRAINDICATION: Uncontrolled hypertension * NRT CONTRAINDICATION: Currently using warfarin * NRT CONTRAINDICATION: Pregnant or breastfeeding, or plans to become pregnant during the next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day point prevalence abstinence (PPA) | At 12 months post randomization | The comparison will use a logistic regression model, following standard intent-to-treat analysis for smoking cessation trials, will be employed, coding all missing outcomes as smoking. The model will adjust for stratification factors and baseline factors that are both imbalanced after randomization and significantly related to the outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day PPA | At 3 and 6 months post randomization | — |
| 24 hour PPA | At 3, 6 and 12 months post randomization | — |
| 7 day PPA | At 3, 6 and 12 months post randomization | — |
| Cost per quitter | At 12 months post randomization | Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. The incremental cost-per-quitter will be estimated as the difference in total cost of delivering the two interventions divided by the difference in the number of 30-day abstinent participants at 12 months. |
| Cost per life year gained | At 12 months post randomization | Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. To compare iCanQuit with iCanQuit plus NRT in terms of life years gained, researchers will calculate the cost per life year gained. |
| Cost per quality-adjusted life year (QALY) gained | At 12 months post randomization | Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. Will estimate cost-per-QALY gained. |
Countries
United States
Contacts
CONTACTJonathan Bricker, PhD
PRINCIPAL_INVESTIGATORJonathan Bricker, PhD
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed