Trial of An Innovative Smartphone Intervention for Smoking Cessation

December 10, 2020 updated by: Fred Hutchinson Cancer Center

Randomized Trial of An Innovative Smartphone Intervention for Smoking Cessation

The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides higher quit rates than the current standard smoking cessation app.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2503

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 or older
  • smokes at least five cigarettes daily for at least past 12 months
  • wants to quit cigarette smoking in the next 30 days
  • if concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days
  • interested in learning skills to quit smoking
  • willing to be randomly assigned to either condition
  • resides in US
  • has at least daily access to their own personal Apple iPhone, Android, or Windows Phone
  • knows how to login and download a smartphone application
  • willing and able to read in English
  • not using other smoking cessation interventions (including apps or our other intervention studies).
  • willing to complete all three follow-up surveys
  • provide email, phone, and mailing address.

Exclusion Criteria:

  • The exclusion criteria are opposite of the inclusion criteria listed above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
This is the experimental arm of the study. This includes receiving the novel/experimental smartphone smoking cessation app. Therapy description withheld to protect the integrity of the study.
Behavioral: Smartphone-delivered Intervention (SmartQuit)
The experimental arm includes an intervention using a novel smartphone smoking cessation app.
Active Comparator: Control
This is the control arm of the study. This includes receiving the standard of care smartphone smoking cessation app. Therapy description withheld to protect the integrity of the study.
Behavioral: : Smartphone-delivered Intervention (Standard of care app)
The control intervention uses a standard of care smartphone smoking cessation app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Point Prevalence Abstinence, Complete-case
Time Frame: 12 months post randomization
Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are excluded for the complete-case analysis. Exact 2-sided CI was based on the observed proportion of participants.
12 months post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Point Prevalence Abstinence, Missing=Smoking Imputation
Time Frame: 12 months post randomization
Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are imputed as still smoking. Exact 2-sided CI was based on the observed proportion of participants.
12 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)
University of Washington

Investigators

  • Principal Investigator: Jonathan Bricker, Ph.D., Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2017

Primary Completion (Actual)

December 27, 2019

Study Completion (Actual)

December 27, 2019

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8317 (CTEP)
  • NCI-2018-02662 (Registry Identifier: NCI / CTRP)
  • RG1001191 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • R01CA192849 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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