Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking

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.

• Quit2Heal (Behavioral), also known as Quit2Heal App, Quit2Heal Smartphone App, Quit2Heal Smartphone Application: Use Quit2Heal app
• QuitGuide (Behavioral), also known as QuitGuide App, QuitGuide Smartphone App, QuitGuide Smartphone Application: Use QuitGuide app
• Survey Administration (Other): Ancillary studies

Primary outcomes

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

Secondary outcomes

• Number of Participants With 30-day Cigarette Smoking Cessation at 6 Months. [At 6 months after randomization]: 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.
• Number of Participants With 30-day Cigarette Smoking Cessation at 3 Months. [At 3 months after randomization]: 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.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Number of Participants With 30-day Cigarette Smoking Cessation at 12 Months. (Primary), Count of participants, Participants: Arm II (QuitGuide App) 40; Arm I (Quit2Heal App) 46 (p 0.371)
• Number of Participants With 30-day Cigarette Smoking Cessation at 6 Months. (Secondary), Count of participants, Participants: Arm II (QuitGuide App) 33; Arm I (Quit2Heal App) 42 (p 0.252)
• Number of Participants With 30-day Cigarette Smoking Cessation at 3 Months. (Secondary), Count of participants, Participants: Arm II (QuitGuide App) 23; Arm I (Quit2Heal App) 32 (p 0.174)

Adverse events

Time frame: From enrollment to end of follow-up, up to 12 months.

• Study Protocol and Statistical Analysis Plan (PDF, 2023-01-22)
• Informed Consent Form (PDF, 2022-04-25)

• Jonathan Bricker, Principal investigator, Fred Hutch/University of Washington Cancer Consortium

NIH grants: R01CA253975