Trial Outcomes & Findings for Gain-framed Messages and NRT for Lung Cancer Screening Patients (NCT NCT03069924)

Last Updated: 2025-01-14

Results Overview

Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

367 participants

Primary outcome timeframe

6 month follow-up

Results posted on

2025-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Unframed Messaging Unframed smoking cessation materials Unframed messaging materials: Unframed smoking cessation materials	Gain-framed Messaging Gain-framed messaging Gain-framed messaging : Gain-framed messaging materials
Overall Study STARTED	183	184
Overall Study COMPLETED	126	116
Overall Study NOT COMPLETED	57	68

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gain-framed Messages and NRT for Lung Cancer Screening Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unframed Messaging n=183 Participants Unframed smoking cessation materials Unframed messaging materials: Unframed smoking cessation materials	Gain-framed Messaging n=184 Participants Gain-framed messaging Gain-framed messaging: Gain-framed messaging materials	Total n=367 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	127 Participants n=5 Participants	115 Participants n=7 Participants	242 Participants n=5 Participants
Age, Categorical >=65 years	56 Participants n=5 Participants	69 Participants n=7 Participants	125 Participants n=5 Participants
Age, Continuous	62.2 Years STANDARD_DEVIATION 5.6 • n=5 Participants	62.7 Years STANDARD_DEVIATION 6.0 • n=7 Participants	62.4 Years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	102 Participants n=7 Participants	210 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	82 Participants n=7 Participants	157 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	66 Participants n=5 Participants	56 Participants n=7 Participants	122 Participants n=5 Participants
Race (NIH/OMB) White	102 Participants n=5 Participants	115 Participants n=7 Participants	217 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	183 participants n=5 Participants	184 participants n=7 Participants	367 participants n=5 Participants
Cigarettes Smoked Per Day	15.6 Cigarettes Smoked Per Day, Average STANDARD_DEVIATION 7.8 • n=5 Participants	15.6 Cigarettes Smoked Per Day, Average STANDARD_DEVIATION 8.2 • n=7 Participants	15.6 Cigarettes Smoked Per Day, Average STANDARD_DEVIATION 8.0 • n=5 Participants
Abstinent at Study Baseline	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month follow-up

Population: All available participants are included in the analysis of 7 day point prevalence abstinence at the 6-month follow up visit.

Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit

Outcome measures

Outcome measures
Measure	Unframed Messaging n=126 Participants Unframed smoking cessation materials Unframed messaging materials: Unframed smoking cessation materials	Gain-framed Messaging n=116 Participants Gain-framed messaging Gain-framed messaging : Gain-framed messaging materials
Smoking Cessation - Available Data	15 Participants	19 Participants

SECONDARY outcome

Timeframe: 6 month follow-up

Population: all participants with data available at the 6-month follow up visit.

Gain-framed messaging vs. Unframed messaging - average reported cigarettes smoked per day.

Outcome measures

Outcome measures
Measure	Unframed Messaging n=126 Participants Unframed smoking cessation materials Unframed messaging materials: Unframed smoking cessation materials	Gain-framed Messaging n=116 Participants Gain-framed messaging Gain-framed messaging : Gain-framed messaging materials
Cigarettes Smoked Per Day - Average	9.7 Average Cigarettes Smoked Per Day Interval 8.3 to 11.1	8.9 Average Cigarettes Smoked Per Day Interval 7.5 to 10.3

SECONDARY outcome

Timeframe: 6 Month Follow up Visit

Population: all randomized participants whom were alive at the 6-month follow up visit.

Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit. Missing participant data imputed to no cessation. 3 participants from the unframed group were not included as they had died prior to the 6-month visit.

Outcome measures

Outcome measures
Measure	Unframed Messaging n=180 Participants Unframed smoking cessation materials Unframed messaging materials: Unframed smoking cessation materials	Gain-framed Messaging n=184 Participants Gain-framed messaging Gain-framed messaging : Gain-framed messaging materials
Smoking Cessation - Imputed	15 Participants	19 Participants

Adverse Events

Unframed Messaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Gain-framed Messaging

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. Benjamin Toll

Medical University of South Carolina

Phone: 843-876-1132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place