Health TrialsbyHealthPanel

iCanQuit Smoking Cessation Among Hispanic Adults

ConditionCigarette Smoking-Related Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • iCanQuit Smartphone App Smoking Cessation Program

    Device

    Receive access to iCanQuit app, with daily push notifications

  • Nicotine Gum

    Drug

    Receive nicotine replacement therapy gum

  • Nicotine Patch

    Drug

    Receive nicotine replacement therapy patch(es)

  • Nicotine Lozenge

    Drug

    Receive nicotine replacement therapy lozenge(s)

  • Survey Administration

    Other intervention

    Ancillary studies

  • Interview

    Other intervention

    Ancillary studies

Treatment groups

854 Participants
are divided into 2 treatment groups
Group A: Arm I (iCanQuit application)Experimental treatment 3 interventions
Group B: Arm II (iCanQuit application and NRT)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

30-day point prevalence abstinence (PPA)

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.

Time frame
At 12 months post randomization

Secondary outcomes

1

30-day PPA

Time frame
At 3 and 6 months post randomization
2

24 hour PPA

Time frame
At 3, 6 and 12 months post randomization
3

7 day PPA

Time frame
At 3, 6 and 12 months post randomization
4

Cost per quitter

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.

Time frame
At 12 months post randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: