Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04409236
• Other study ID #: RG1007577
• Secondary ID: NCI-2020-0344210
• Status: Recruiting
• Phase: Phase 3
• Start date: July 19, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: December 2023
• Source: Fred Hutchinson Cancer Center
• Contact: Jonathan Bricker
• Phone: 877-250-6641
• Email: quit2heal[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 422
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Behavioral:
• Quit2Heal
Use Quit2Heal app
• QuitGuide
Use QuitGuide app

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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