Trial Outcomes & Findings for Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors (NCT NCT06476548)

NCT ID: NCT06476548

Last Updated: 2026-01-07

Results Overview

Percentage of participants who downloaded the study's smartphone application and attended the first counseling session.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: At 4 weeks
• Results posted on: 2026-01-07

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors

Baseline characteristics by cohort

Measure	Usability Testing n=12 Participants 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.
Age, Customized 30-39	0 Participants n=37 Participants
Age, Customized 40-49	3 Participants n=37 Participants
Age, Customized 50-59	3 Participants n=37 Participants
Age, Customized 60-69	6 Participants n=37 Participants
Age, Customized 70-79	0 Participants n=37 Participants
Sex: Female, Male Female	8 Participants n=37 Participants
Sex: Female, Male Male	4 Participants n=37 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=37 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=37 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants
Race (NIH/OMB) Black or African American	2 Participants n=37 Participants
Race (NIH/OMB) White	10 Participants n=37 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants
Region of Enrollment United States	12 Participants n=37 Participants

PRIMARY outcome

Timeframe: At 4 weeks

Percentage of participants who downloaded the study's smartphone application and attended the first counseling session.

Outcome measures

Measure

Usability Testing n=12 Participants 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.

Retention Rate

91.7 percentage of Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure

Usability Testing n=11 Participants 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.

Likability of Mindfulness Practices

6 score on a scale Interval 2.0 to 6.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure

Usability Testing n=11 Participants 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.

Utility of Mindfulness Practices

5 score on a scale Interval 1.0 to 6.0

Adverse Events

Usability Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christine Vinci

Moffitt Cancer Center

Phone: 813-745-5421

Email: Christine.Vinci@moffitt.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place