CancerQuit2HealNCT03600038
Smoking Cessation Smartphone App for Cancer Patients (Quit2Heal Study)
A study testing Experimental smoking cessation smartphone app in people with Cancer and Smoking, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to determine whether the novel smartphone application designed specifically for cancer patients to quit smoking (Quit2Heal) provides higher quit rates than the current standard smoking cessation app. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Experimental smoking cessation smartphone app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 in the past 12 months
- has 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
- resides in US
Show all 13Show fewer
- has at least daily access to their own smartphone
- knows how to login and download a smartphone application from the Apple app store or Android Play app store
- willing and able to read in English
- not currently using cessation medications or enrolled in other smoking cessation programs, and
- has never used the NCI's Quit Guide smartphone application.
- willing and able to complete one follow-up survey
- willing to provide email, phone, and mailing address.
Who cannot join
- The exclusion criteria are opposite of the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Pilot Trial of a Smartphone Smoking Cessation Application Intervention for Cancer Patients (Quit2Heal Study)
The goal of this study is to determine whether the novel smartphone application designed specifically for cancer patients to quit smoking (Quit2Heal) provides higher quit rates than the current standard smoking cessation app.
Read the detailed description
Cigarette smoking has harmful effects on cancer patients' treatment and prognosis, but there are systemic barriers to delivering smoking cessation interventions to cancer patients. One solution for addressing these barriers is to give patients immediate access to smoking cessation treatment via a smartphone application. The Quit2Heal smartphone app is engaging and tailored to the specific needs of cancer patients, and can be integrated into routine cancer care. The goal of this study is to determine whether Quit2Heal provides higher quit rates than the current standard smoking cessation app.
- Being tested
- Experimental smoking cessation smartphone app, Standard of care smoking cessation smartphone app
- Keywords
- Smoking cessation, App for quitting smoking, Cancer, Oncology
- Medical subject headings
- Neoplasms, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental smoking cessation smartphone appBehavioural
The experimental arm includes an intervention using a novel/experimental smartphone smoking cessation app.
Standard of care smoking cessation smartphone appBehavioural
The control intervention uses a standard of care smartphone smoking cessation app.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | This is the experimental arm of the study. This includes receiving the novel/experimental smoking cessation smartphone app. Therapy description of experimental app withheld to protect the integrity of the study. Receives: Behavioral: Experimental smoking cessation smartphone app |
| Control | Active comparator | This is the control arm of the study. This includes receiving the standard of care smoking cessation smartphone app. Therapy description of standard of care app withheld to protect the integrity of the study. Receives: Behavioral: Standard of care smoking cessation smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day point prevalence abstinence
No smoking in the past 30 days, as reported 2 months post treatment.
Measured: 2 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start2 Apr 2018
- Primary completion31 Jul 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), CVS Health Foundation
- Responsible party
- Sponsor
- Investigators
- Jonathan Bricker, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600038
- Sponsor's protocol ID
- 8630
- Other IDs
- NCI-2018-02641, RG1001682, P30CA015704
- Acronym
- Quit2Heal
- Status last verified
- Dec 2019
- First submitted
- 17 Jul 2018
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bricker JB, Watson NL, Heffner JL, Sullivan B, Mull K, Kwon D, Westmaas JL, Ostroff J. A Smartphone App Designed to Help Cancer Patients Stop Smoking: Results From a Pilot Randomized Trial on Feasibility, Acceptability, and Effectiveness. JMIR Form Res. 2020 Jan 17;4(1):e16652. doi: 10.2196/16652.
PubMed 31951215
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of a Smartphone Smoking Cessation Application Intervention for Cancer Patients (Quit2Heal Study)
- ClinicalTrials.gov ID
- NCT03600038
- Acronym / sponsor ID
- Quit2Heal / 8630
- Keywords
- Smoking cessation, App for quitting smoking, Cancer, Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), CVS Health Foundation
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine whether the novel smartphone application designed specifically for cancer patients to quit smoking (Quit2Heal) provides higher quit rates than the current standard smoking cessation app.
Detailed description
Cigarette smoking has harmful effects on cancer patients' treatment and prognosis, but there are systemic barriers to delivering smoking cessation interventions to cancer patients. One solution for addressing these barriers is to give patients immediate access to smoking cessation treatment via a smartphone application. The Quit2Heal smartphone app is engaging and tailored to the specific needs of cancer patients, and can be integrated into routine cancer care. The goal of this study is to determine whether Quit2Heal provides higher quit rates than the current standard smoking cessation app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Experimental smoking cessation smartphone appThis is the experimental arm of the study. This includes receiving the novel/experimental smoking cessation smartphone app. Therapy description of experimental app withheld to protect the integrity of the study. |
| Control | Active comparator | Behavioral: Standard of care smoking cessation smartphone appThis is the control arm of the study. This includes receiving the standard of care smoking cessation smartphone app. Therapy description of standard of care app withheld to protect the integrity of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- age 18 or older
- diagnosed with cancer in the past 12 months
- has 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 (1 listed)
- The exclusion criteria are opposite of the inclusion criteria listed above.
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 |
|---|---|---|
| Experimental smoking cessation smartphone appThe experimental arm includes an intervention using a novel/experimental smartphone smoking cessation app. | Behavioural | Experimental |
| Standard of care smoking cessation smartphone appThe control intervention uses a standard of care smartphone smoking cessation app. | Behavioural | Control |
Primary outcome
30-day point prevalence abstinence
Time frame: 2 months post randomization
No smoking in the past 30 days, as reported 2 months post treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Derived from this study: PubMed 31951215Bricker JB, Watson NL, Heffner JL, Sullivan B, Mull K, Kwon D, Westmaas JL, Ostroff J. A Smartphone App Designed to Help Cancer Patients Stop Smoking: Results From a Pilot Randomized Trial on Feasibility, Acceptability, and Effectiveness. JMIR Form Res. 2020 Jan 17;4(1):e16652. doi: 10.2196/16652.
- Quit2Heal Study recruitment websiteLink provided by the sponsor.
- 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 Experimental smoking cessation smartphone app in people with Cancer and Smoking, 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 13 inclusion and 1 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 9 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30-day point prevalence abstinence (time frame: 2 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03600038, which also lists 1 linked publication.
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 9 Dec 2019.