Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Interventions
BEHAVIORALQuit2Heal
Use Quit2Heal app
BEHAVIORALQuitGuide
Use QuitGuide app
OTHERSurvey Administration
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
American Cancer Society, Inc.
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Bricker
Fred Hutch/University of Washington Cancer Consortium
Participant flow
Recruitment details
Adult cancer patients who smoke were recruited nationally between 07/19/2021 and 06/03/2024 via social media ads, search engine results, and cancer clinics.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.0 Years STANDARD_DEVIATION 11 |
| Cancer Stage Stage 0, I, or II | 103 Participants |
| Cancer Stage Stage III or IV | 66 Participants |
| Cancer Stage Unknown | 86 Participants |
| CESD-20 Depression Screen CESD-20 score greater than or equal to 16 | 132 Participants |
| CESD-20 Depression Screen CESD-20 score less than 16 | 70 Participants |
| Education Level High school or less education | 60 Participants |
| Education Level Some college or more education | 153 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 408 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 176 Participants |
| Sex/Gender, Customized Sex Female | 341 Participants |
| Sex/Gender, Customized Sex Male | 82 Participants |
| Sex/Gender, Customized Sex Unknown | 1 Participants |
| Smoking Level 10 or fewer cigarettes per day | 85 Participants |
| Smoking Level 11-20 cigarettes per day | 97 Participants |
| Smoking Level 21 or more cigarettes per day | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 214 | 1 / 213 |
| other Total, other adverse events | 0 / 214 | 0 / 213 |
| serious Total, serious adverse events | 0 / 214 | 0 / 213 |
Outcome results
None listed