Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04409236
Collaborator
National Cancer Institute (NCI) (NIH), American Cancer Society, Inc. (Other), Memorial Sloan Kettering Cancer Center (Other)
422
1
2
46.4
9.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Quit2Heal
  • Behavioral: QuitGuide
  • Other: Survey Administration
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
422 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Randomized Trial of a Smartphone Application to Help Cancer Patients Stop Smoking (Quit2Heal)
Actual Study Start Date :
Jul 19, 2021
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2025

Arms and Interventions

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.

Behavioral: Quit2Heal
Use Quit2Heal app
Other Names:
  • Quit2Heal App
  • Quit2Heal Smartphone App
  • Quit2Heal Smartphone Application
  • Other: Survey Administration
    Ancillary studies

    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.

    Behavioral: QuitGuide
    Use QuitGuide app
    Other Names:
  • QuitGuide App
  • QuitGuide Smartphone App
  • QuitGuide Smartphone Application
  • Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with 30-day cigarette smoking cessation at 12 months. [At 12 months after randomization]

      No smoking at all in the past 30 or more days.

    Secondary Outcome Measures

    1. Number of participants with 30-day cigarette smoking cessation at 3 months. [At 3 months after randomization]

      No smoking at all in the past 30 or more days.

    2. Number of participants with 30-day cigarette smoking cessation at 6 months. [At 6 months after randomization]

      No smoking at all in the past 30 or more days.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosed with cancer within the past 12 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

    • Current use of Food and Drug Administration (FDA)-approved quit smoking medications: nicotine patch, nicotine gum, nicotine lozenge, nicotine nasal spray, nicotine inhaler, Chantix (varenicline), or Wellbutrin (Zyban/bupropion)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)
    • American Cancer Society, Inc.
    • Memorial Sloan Kettering Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04409236
    Other Study ID Numbers:
    • RG1007577
    • NCI-2020-03442
    • 10432
    • R01CA253975
    First Posted:
    Jun 1, 2020
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 22, 2022