Quit2Heal Smartphone App in Helping Cancer Patients Quit... | NCT04409236

Studies
Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking

NCT04409236

Sponsor

Fred Hutchinson Cancer Center

Status

Active, not recruiting

Last Update Posted

Sep 17, 2025Actual

Enrollment

427Actual

Phase

Phase 3

Conditions

Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm

Interventions

Quit2Heal
QuitGuide
Survey Administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
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		View source

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2021Actual

Primary Completion Date

Sep 11, 2025Actual

Completion Date

Sep 11, 2026Estimated

First Submitted Date

May 26, 2020

First Submission Date that Met QC Criteria

May 29, 2020

First Posted Date

Jun 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2025

Last Update Posted Date

Sep 17, 2025Actual

Name	Class
National Cancer Institute (NCI)	NIH
American Cancer Society, Inc.	OTHER
Memorial Sloan Kettering Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

427Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Quit2Heal	Behavioral	Use Quit2Heal app	Arm I (Quit2Heal app)	Quit2Heal App

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonathan Bricker	Fred Hutch/University of Washington Cancer Consortium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fred Hutch/University of Washington Cancer Consortium		Seattle	Washington	98109	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided