Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking

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: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm
• Intervention / Treatment: Other: Survey Administration; Behavioral: Quit2Heal; Behavioral: QuitGuide

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 (Estimated): 422
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jonathan Bricker; Phone Number: 877-250-6641; Email: quit2heal@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Jonathan Bricker; Phone Number: 877-250-6641; Email: quit2heal@fredhutch.org
      • Principal Investigator: Jonathan Bricker

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	No smoking at all in the past 30 or more days.	At 12 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with 30-day cigarette smoking cessation at 3 months.	No smoking at all in the past 30 or more days.	At 3 months after randomization
Number of participants with 30-day cigarette smoking cessation at 6 months.	No smoking at all in the past 30 or more days.	At 6 months after randomization

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 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): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• 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