Trial Outcomes & Findings for Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites (NCT NCT03291587)
NCT ID: NCT03291587
Last Updated: 2022-07-25
Results Overview
7-day sustained smoking abstinence will be measured by the question "Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days?" in patient survey.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1094 participants
Primary outcome timeframe
6 months (after baseline)
Results posted on
2022-07-25
Participant Flow
Twenty-six radiology facilities in twenty states were selected to participate. Clinics were matched based on lung screening volume and racial/ethnic diversity, and then assigned to the intervention or usual care group. Radiology facilities in the intervention arm participated in multi-faceted implementation strategies targeting the radiology facility and its clinical team. Each clinic was asked to recruit 50 participants.
Goal was 1100 and there were 6 participants later found to be ineligible due to mis-specified eligibility criteria which is why we have 1094 total.
Participant milestones
| Measure |
Intervention
Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
|
Usual Care
No training or performance coaching calls on personnel, just usual clinic practice.
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
|
|---|---|---|
|
Overall Study
STARTED
|
523
|
571
|
|
Overall Study
14 Day Follow-up
|
483
|
547
|
|
Overall Study
3 Month Follow-up
|
445
|
538
|
|
Overall Study
COMPLETED
|
442
|
514
|
|
Overall Study
NOT COMPLETED
|
81
|
57
|
Reasons for withdrawal
| Measure |
Intervention
Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
|
Usual Care
No training or performance coaching calls on personnel, just usual clinic practice.
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
62
|
43
|
|
Overall Study
Refused to Answer
|
5
|
2
|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Not interested in participating
|
8
|
6
|
|
Overall Study
Too busy to participate
|
4
|
2
|
Baseline Characteristics
Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites
Baseline characteristics by cohort
| Measure |
Intervention
n=523 Participants
Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
|
Usual Care
n=571 Participants
No training or performance coaching calls on personnel, just usual clinic practice.
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
|
Total
n=1094 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age in years · 55-64
|
286 Participants
n=93 Participants
|
333 Participants
n=4 Participants
|
619 Participants
n=27 Participants
|
|
Age, Customized
Age in years · 65-74
|
213 Participants
n=93 Participants
|
220 Participants
n=4 Participants
|
433 Participants
n=27 Participants
|
|
Age, Customized
Age in years · 75 or older
|
24 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Gender, participant reported · Male
|
249 Participants
n=93 Participants
|
281 Participants
n=4 Participants
|
530 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Gender, participant reported · Female
|
269 Participants
n=93 Participants
|
283 Participants
n=4 Participants
|
552 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Gender, participant reported · Non-Binary
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Gender, participant reported · Not Reported
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White, non-Hispanic
|
423 Participants
n=93 Participants
|
452 Participants
n=4 Participants
|
875 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black, non-Hispanic
|
68 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
142 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic, all races
|
5 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian, non-Hispanic
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not Reported
|
16 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Education
No high school degree, high school degree, or completion of General Education Development (GED) test
|
248 Participants
n=93 Participants
|
307 Participants
n=4 Participants
|
555 Participants
n=27 Participants
|
|
Education
Some post high school education or college degree or graduate degree
|
272 Participants
n=93 Participants
|
260 Participants
n=4 Participants
|
532 Participants
n=27 Participants
|
|
Education
Not reported
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Annual Household Income
Less than $15000
|
94 Participants
n=93 Participants
|
137 Participants
n=4 Participants
|
231 Participants
n=27 Participants
|
|
Annual Household Income
$15000 - $34999
|
113 Participants
n=93 Participants
|
133 Participants
n=4 Participants
|
246 Participants
n=27 Participants
|
|
Annual Household Income
$35000 - $64999
|
116 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
232 Participants
n=27 Participants
|
|
Annual Household Income
$65000 or higher
|
117 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
226 Participants
n=27 Participants
|
|
Annual Household Income
Not Reported
|
83 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Marital Status
Married
|
265 Participants
n=93 Participants
|
284 Participants
n=4 Participants
|
549 Participants
n=27 Participants
|
|
Marital Status
Not Currently Married
|
254 Participants
n=93 Participants
|
283 Participants
n=4 Participants
|
537 Participants
n=27 Participants
|
|
Marital Status
Not Reported
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Employment
Working full- or part-time
|
173 Participants
n=93 Participants
|
187 Participants
n=4 Participants
|
360 Participants
n=27 Participants
|
|
Employment
Retired
|
226 Participants
n=93 Participants
|
226 Participants
n=4 Participants
|
452 Participants
n=27 Participants
|
|
Employment
Disabled
|
98 Participants
n=93 Participants
|
124 Participants
n=4 Participants
|
222 Participants
n=27 Participants
|
|
Employment
Homemaker, Caregiver, Student, or Unemployed
|
24 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Employment
Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Personal Cancer History
|
41 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Family Cancer History
|
136 Participants
n=93 Participants
|
165 Participants
n=4 Participants
|
301 Participants
n=27 Participants
|
|
Smoke a cigarette within 30 minutes of waking
|
372 Participants
n=93 Participants
|
403 Participants
n=4 Participants
|
775 Participants
n=27 Participants
|
|
Cigarettes per day
|
17.3 number of cigarettes per day
STANDARD_DEVIATION 10.4 • n=93 Participants
|
17.1 number of cigarettes per day
STANDARD_DEVIATION 8.9 • n=4 Participants
|
17.2 number of cigarettes per day
STANDARD_DEVIATION 9.6 • n=27 Participants
|
|
Pack Years
|
45.7 pack of cigarettes per day per year
STANDARD_DEVIATION 25.7 • n=93 Participants
|
46.5 pack of cigarettes per day per year
STANDARD_DEVIATION 24.3 • n=4 Participants
|
46.1 pack of cigarettes per day per year
STANDARD_DEVIATION 25.0 • n=27 Participants
|
|
Another smoker in the household
|
166 Participants
n=93 Participants
|
158 Participants
n=4 Participants
|
324 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 months (after baseline)Population: Those with completed 6 month surveys.
7-day sustained smoking abstinence will be measured by the question "Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days?" in patient survey.
Outcome measures
| Measure |
Intervention
n=442 Participants
Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
|
Usual Care
n=514 Participants
No training or performance coaching calls on personnel, just usual clinic practice.
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
|
|---|---|---|
|
Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
|
13.0 percentage of participants
Interval 9.7 to 17.4
|
13.5 percentage of participants
Interval 10.3 to 17.6
|
SECONDARY outcome
Timeframe: 6 months (after baseline)Population: Cotinine was requested only for those that self-reported quitting for at least 7 days at the 6 month survey.
7-day Sustained Smoking abstinence will be validated using a salivary cotinine test in non smokers. Abstinence will be determined by percentage of smokers whose tests come back negative for cotinine. Low levels of cotinine less than 15 milligrams per milliliter (mg/mL) would suggest true smoking cessation and levels higher than or equal to 15 mg/mL would suggest they are still smoking.
Outcome measures
| Measure |
Intervention
n=51 Participants
Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
|
Usual Care
n=61 Participants
No training or performance coaching calls on personnel, just usual clinic practice.
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
|
|---|---|---|
|
Salivary Cotinine Test for Non-Smokers
High: greater than or equal to 15 mg/mL
|
13 Participants
|
10 Participants
|
|
Salivary Cotinine Test for Non-Smokers
Low: Less than 15 mg/mL
|
10 Participants
|
20 Participants
|
|
Salivary Cotinine Test for Non-Smokers
Unknown, not tested
|
28 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 3 months (after baseline)Population: Those that had 3 month surveys complete
Short-tem smoking abstinence will be measured as part of the patient survey as the percentage of patients who report that they have not smoked.
Outcome measures
| Measure |
Intervention
n=445 Participants
Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
|
Usual Care
n=538 Participants
No training or performance coaching calls on personnel, just usual clinic practice.
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
|
|---|---|---|
|
Short-term Smoking Abstinence - Patient Survey
|
6.5 percentage of participants
Interval 4.4 to 9.5
|
5.5 percentage of participants
Interval 3.8 to 8.0
|
SECONDARY outcome
Timeframe: <= 14 days after baselinePopulation: Those that completed 14 day survey
Fidelity to the intervention will be measured by a patient survey that asks patients if they received up to 18 cessation services during the screening visit. This is the total each participant reported receiving and can range from 0 to 18, with higher values representing more services.
Outcome measures
| Measure |
Intervention
n=483 Participants
Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
|
Usual Care
n=547 Participants
No training or performance coaching calls on personnel, just usual clinic practice.
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, \<14 days, 3 months, and 6 months)
|
|---|---|---|
|
Total Number of Services Participant Reported Received at 14 Days
|
7.51 total services reported
Standard Deviation 6.33
|
7.86 total services reported
Standard Deviation 6.07
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place