Any Cancer Type
Conditions
Keywords
Smoking Cessation, Cancer Survivor
Brief summary
The purpose of the study is to obtain feedback on a new quit-smoking treatment among individuals with a cancer diagnosis using a prototype app we developed.
Detailed description
The study aims to test the usability of the prototype app in conjunction with face-to-face brief cessation counseling and nicotine replacement therapy in a single-arm trial.
Interventions
DEVICEEMI
Participants will complete 3 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 2 online surveys, and a brief phone call at the end of the study to provide feedback. In the first 3 weeks, participants will use the prototype app every day to complete ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-20 minutes). In the final week, participants will continue completing EMAs. Participants will also be provided with nicotine patches.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Having smoked at least one cigarette (even one or two puffs) within the past 30 days. * Having been diagnosed with cancer. * Willing to give quitting a try as part of the study. * Having a smartphone that allows installation of the app. * Willingness to download and use the app daily. * Valid home address and functioning phone number. * Being able to read, write, and speak English.
Exclusion criteria
* Being enrolled in a smoking cessation program. * Current use of smoking cessation medications. * Evidence of current psychosis. * Current/planning pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | At 4 weeks | Percentage of participants who downloaded the study's smartphone application and attended the first counseling session. |
| Likability of Mindfulness Practices | At 4 weeks | Participants will rate the likability of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely dislike) to 6 (Extremely like). |
| Utility of Mindfulness Practices | At 4 weeks | Participants will rate their perceived helpfulness of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely unhelpful) to 6 (Extremely helpful). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristine Vinci, PhD
Moffitt Cancer Center
PRINCIPAL_INVESTIGATORMin-Jeong Yang, PhD
Moffitt Cancer Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usability Testing Participants will receive brief counseling, nicotine replacement therapy, and intervention content delivered via the app.
EMI: Participants will complete 3 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 2 online surveys, and a brief phone call at the end of the study to provide feedback. In the first 3 weeks, participants will use the prototype app every day to complete ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-20 minutes). In the final week, participants will continue completing EMAs. Participants will also be provided with nicotine patches. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Usability Testing |
|---|---|
| Age, Customized 30-39 | 0 Participants |
| Age, Customized 40-49 | 3 Participants |
| Age, Customized 50-59 | 3 Participants |
| Age, Customized 60-69 | 6 Participants |
| Age, Customized 70-79 | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Likability of Mindfulness Practices
Participants will rate the likability of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely dislike) to 6 (Extremely like).
Time frame: At 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usability Testing | Likability of Mindfulness Practices | 6 score on a scale |
Primary
Retention Rate
Percentage of participants who downloaded the study's smartphone application and attended the first counseling session.
Time frame: At 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usability Testing | Retention Rate | 91.7 percentage of Participants |
Primary
Utility of Mindfulness Practices
Participants will rate their perceived helpfulness of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely unhelpful) to 6 (Extremely helpful).
Time frame: At 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usability Testing | Utility of Mindfulness Practices | 5 score on a scale |