Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking

NCT04409236 | Active Not Recruiting Results

• 4 other identifiers: RG1007577NCI-2020-0344210432R01CA253975
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 30-day Cigarette Smoking Cessation at 12 Months.

  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 Outcomes (2)

• Number of Participants With 30-day Cigarette Smoking Cessation at 6 Months.

  At 6 months after randomization

• Number of Participants With 30-day Cigarette Smoking Cessation at 3 Months.

  At 3 months after randomization

Study Arms (2)

Arm I (Quit2Heal app)

EXPERIMENTAL

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; Other: Survey Administration

Arm II (QuitGuide app)

ACTIVE COMPARATOR

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; Other: Survey Administration

Interventions

Quit2Heal BEHAVIORAL

Use Quit2Heal app

Also known as: Quit2Heal App, Quit2Heal Smartphone App, Quit2Heal Smartphone Application

Arm I (Quit2Heal app)

QuitGuide BEHAVIORAL

Use QuitGuide app

Also known as: QuitGuide App, QuitGuide Smartphone App, QuitGuide Smartphone Application

Arm II (QuitGuide app)

Survey Administration OTHER

Ancillary studies

Arm I (Quit2Heal app); Arm II (QuitGuide app)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Results Point of Contact

• Title: Dr. Jonathan Bricker
• Organization: Fred Hutchinson Cancer Center

jbricker@fredhutch.org

206-667-5074

Study Officials

• Jonathan Bricker

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 1, 2020
• Study Start: July 19, 2021
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2026
• Last Updated: September 4, 2026
• Results First Posted: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)