Clinical trial NCT04409236: Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking
Official title: Randomized Trial of a Smartphone Application to Help Cancer Patients Stop Smoking (Quit2Heal)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Cancer Society, Inc.
name: Memorial Sloan Kettering Cancer Center
First posted: 2020-06-01
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of participants with 30-day cigarette smoking cessation at 12 months.
timeFrame: At 12 months after randomization
Secondary outcomes:
measure: Number of participants with 30-day cigarette smoking cessation at 3 months.
timeFrame: At 3 months after randomization
measure: Number of participants with 30-day cigarette smoking cessation at 6 months.
timeFrame: At 6 months after randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jonathan Bricker
role: PRINCIPAL_INVESTIGATOR
References: