Hematopoietic and Lymphoid System NeoplasmNCT04409236
Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking
A study testing Quit2Heal, QuitGuide and Survey Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Quit2Heal, QuitGuide and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 11 Sep 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: 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.
Read the 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.
- Being tested
- Quit2Heal, QuitGuide, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit2HealBehavioural
Also called Quit2Heal App, Quit2Heal Smartphone App, Quit2Heal Smartphone Application
Use Quit2Heal app
QuitGuideBehavioural
Also called QuitGuide App, QuitGuide Smartphone App, QuitGuide Smartphone Application
Use QuitGuide app
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: QuitGuide; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months after randomization
Secondary outcomes (2)
Number of Participants With 30-day Cigarette Smoking Cessation at 6 Months.
At 6 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.
Measured: At 6 months after randomization
Number of Participants With 30-day Cigarette Smoking Cessation at 3 Months.
At 3 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.
Measured: At 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start19 Jul 2021
- Primary completion11 Sep 2025
- Study completion11 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc., Memorial Sloan Kettering Cancer Center
- Responsible party
- Principal investigator, Jonathan Bricker, Fred Hutchinson Cancer Center
- Investigators
- Jonathan Bricker, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409236
- Sponsor's protocol ID
- RG1007577
- Other IDs
- NCI-2020-03442, 10432, R01CA253975
- Status last verified
- Sep 2026
- First submitted
- 26 May 2020
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Smartphone Application to Help Cancer Patients Stop Smoking (Quit2Heal)
- ClinicalTrials.gov ID
- NCT04409236
- Acronym / sponsor ID
- RG1007577
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc., Memorial Sloan Kettering Cancer Center
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2026 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Posted 4 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Quit2Heal app) | Experimental | Behavioral: Quit2Heal, Other: Survey AdministrationPatients 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) | Active comparator | Behavioral: QuitGuide, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quit2HealAlso: Quit2Heal App, Quit2Heal Smartphone App, Quit2Heal Smartphone ApplicationUse Quit2Heal app | Behavioural | Arm I (Quit2Heal app) |
| QuitGuideAlso: QuitGuide App, QuitGuide Smartphone App, QuitGuide Smartphone ApplicationUse QuitGuide app | Behavioural | Arm II (QuitGuide app) |
| Survey AdministrationAncillary studies | Other | Arm I (Quit2Heal app), Arm II (QuitGuide app) |
Primary outcome
Number of Participants With 30-day Cigarette Smoking Cessation at 12 Months.
Time frame: At 12 months after randomization
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.
2 secondary outcomes
Number of Participants With 30-day Cigarette Smoking Cessation at 6 Months.
Time frame: At 6 months after randomization
Number of Participants With 30-day Cigarette Smoking Cessation at 3 Months.
Time frame: At 3 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Bricker principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quit2Heal, QuitGuide and Survey Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 30-day Cigarette Smoking Cessation at 12 Months. (time frame: At 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.