Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking

Phase 3

Active, not recruiting

• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm
• Interventions: Behavioral: Quit2Heal; Behavioral: QuitGuide; Other: Survey Administration

• Registration Number: NCT04409236
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

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 Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-01
• Study Start: 2021-07-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-09-11
• Study Completion: 2026-09-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 427

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (Quit2Heal app)	Quit2Heal	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 I (Quit2Heal app)	Survey Administration	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 (QuitGuide app)	QuitGuide	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.
Arm II (QuitGuide app)	Survey Administration	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States