Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking

September 2, 2026 updated by: Jonathan Bricker, Fred Hutchinson Cancer Center

Randomized Trial of a Smartphone Application to Help Cancer Patients Stop Smoking (Quit2Heal)

This phase III trial compares the Quit2Heal smoking cessation smartphone application (app) to the QuitGuide app in helping cancer patients quit smoking. Both apps provide tools to cope with urges to smoke, step-by-step guides for quitting smoking, help in planning for quitting and staying tobacco-free, and scientifically-based recommendations for how to select medications that aid in smoking cessation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.

ARM II: Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.

After randomization, patients are followed up at 3, 6, and 12 months.

Study Type

Interventional

Enrollment (Actual)

427

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 Hutch/University of Washington Cancer Consortium

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

No

Description

Inclusion Criteria:

  • Age 18 or older
  • Diagnosed with cancer within the past 24 months or currently receiving or planning to receive cancer treatment in the next 3 months
  • Smoked a cigarette (even a puff) in the past 30 days
  • Interested in learning skills to quit smoking
  • Willing to be randomly assigned to either smartphone application
  • Live in the United States and will remain in the United States (US) for the next 12 months
  • Have at least daily access to their own smartphone
  • Know how to download a smartphone application
  • Be willing and able to read English
  • Not currently (i.e., within past 30 days) using other smoking cessation interventions
  • Have never participated in our prior research trials
  • Have never used the National Cancer Institute (NCI)'s QuitGuide app
  • Being willing to complete a follow-up survey at 3, 6, and 12 months post-randomization
  • Providing email, phone number(s), and mailing address

Exclusion Criteria:

  • Currently (i.e., within past 30 days) using other smoking cessation interventions
  • Has participated in our prior research trials
  • Has used the NCI's QuitGuide app
  • Not willing to complete a follow-up survey at 3, 6, and 12 months post-randomization
  • Not providing email, phone number(s), and mailing address

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (Quit2Heal app)
Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
Other: Survey Administration
Ancillary studies
Behavioral: Quit2Heal
Use Quit2Heal app
Other Names:
  • Quit2Heal App
  • Quit2Heal Smartphone App
  • Quit2Heal Smartphone Application
Active Comparator: Arm II (QuitGuide app)
Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
Other: Survey Administration
Ancillary studies
Behavioral: QuitGuide
Use QuitGuide app
Other Names:
  • QuitGuide App
  • QuitGuide Smartphone App
  • QuitGuide Smartphone Application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With 30-day Cigarette Smoking Cessation at 12 Months.
Time Frame: At 12 months after randomization
The primary endpoint is 30-day point prevalence abstinence for cigarette smoking at 12 months post-randomization. At 12 months, smoking abstinence is assessed by asking participants: "When was the last time you smoked, or even tried, a cigarette?" Response choices are "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Participants reporting no cigarette consumption in the past 30 days are considered abstinent for the 30-day outcome. Missing outcome data are handled using standard intent-to-treat analysis, with all missing data coded as smoking.
At 12 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With 30-day Cigarette Smoking Cessation at 6 Months.
Time Frame: At 6 months after randomization
At 6 months, smoking abstinence is assessed by asking participants: "When was the last time you smoked, or even tried, a cigarette?" Response choices are "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Participants reporting no cigarette consumption in the past 30 days are considered abstinent for the 30-day outcome. Missing outcome data are handled using standard intent-to-treat analysis, with all missing data coded as smoking.
At 6 months after randomization
Number of Participants With 30-day Cigarette Smoking Cessation at 3 Months.
Time Frame: At 3 months after randomization
At 3 months, smoking abstinence is assessed by asking participants: "When was the last time you smoked, or even tried, a cigarette?" Response choices are "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Participants reporting no cigarette consumption in the past 30 days are considered abstinent for the 30-day outcome. Missing outcome data are handled using standard intent-to-treat analysis, with all missing data coded as smoking.
At 3 months after 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)
Memorial Sloan Kettering Cancer Center
American Cancer Society, Inc.

Investigators

  • Principal Investigator: Jonathan Bricker, Fred Hutch/University of Washington Cancer Consortium

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)

July 19, 2021

Primary Completion (Actual)

September 11, 2025

Study Completion (Estimated)

September 11, 2026

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1007577
  • NCI-2020-03442 (Other Grant/Funding Number: CTRP (Clinical Trial Reporting Program))
  • 10432 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • R01CA253975 (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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