NCT03291587: OaSiS

Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites

Completed NA Results posted Last updated 25 July 2022

What this trial tests

NA trial testing Personnel Training and Coaching Calls in Smoking Cessation in 1,094 participants. Completed in 22 February 2021.

Timeline

1 June 2018

Primary endpoint
22 February 2021

22 February 2021

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	1,094
Start date	1 June 2018
Primary completion	22 February 2021
Estimated completion	22 February 2021
Sites	49 locations across United States

Drugs / interventions tested

• Personnel Training and Coaching Calls

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey Primary · 6 months (after baseline)

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.

Group	Value	95% CI
Intervention	13.0	9.7 – 17.4
Usual Care	13.5	10.3 – 17.6

Salivary Cotinine Test for Non-Smokers Secondary · 6 months (after baseline)

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.

Group	Value	95% CI
Intervention	13
Usual Care	10
Intervention	10
Usual Care	20
Intervention	28
Usual Care	31

Short-term Smoking Abstinence - Patient Survey Secondary · 3 months (after baseline)

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.

Group	Value	95% CI
Intervention	6.5	4.4 – 9.5
Usual Care	5.5	3.8 – 8.0

Total Number of Services Participant Reported Received at 14 Days Secondary · <= 14 days after baseline

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.

Group	Value	95% CI
Intervention	7.51	± 6.33
Usual Care	7.86	± 6.07

Sponsor's own description

Evaluate a multi-faceted training program to improve short-term smoking cessation rates (\<14 days post-visit) and short (3 months) and sustained abstinence (6 months) among 1,114 enrolled smokers who present for low-dose computed tomography (LDCT) lung cancer screening in 26 community-based practices.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evolution of Cancer Care Delivery Research in the NCI Community Oncology Research Program.
   Geiger AM, O'Mara AM, McCaskill-Stevens WJ, Adjei B, et al · · 2020 · cited 32× · PMID 31845965 · DOI 10.1093/jnci/djz234
2. The Optimizing Lung Screening Trial (WF-20817CD): Multicenter Randomized Effectiveness Implementation Trial to Increase Tobacco Use Cessation for Individuals Undergoing Lung Screening.
   Foley KL, Dressler EV, Weaver KE, Sutfin EL, et al · · 2023 · cited 20× · PMID 36931460 · DOI 10.1016/j.chest.2023.03.013
3. The OaSiS trial: A hybrid type II, national cluster randomized trial to implement smoking cessation during CT screening for lung cancer.
   Foley KL, Miller DP, Weaver K, Sutfin EL, et al · · 2020 · cited 13× · PMID 32087340 · DOI 10.1016/j.cct.2020.105963
4. Organizational Characteristics and Smoking Cessation Support in Community-Based Lung Cancer Screening Programs.
   Bellinger C, Foley KL, Dressler EV, Kittel C, et al · · 2022 · cited 4× · PMID 35247325 · DOI 10.1016/j.jacr.2022.01.014
5. Intracluster correlation coefficients from cluster randomized trials conducted within the NCI Community Oncology Research Program (NCORP).
   Snavely AC, Gunn HJ, Lee JW, Pugh SL, et al · · 2025 · cited 3× · PMID 39989039 · DOI 10.1093/jncimonographs/lgae048
6. Predictors of Cessation Readiness among Cigarette Smokers Presenting for Low-Dose CT Lung Cancer Screening in Community Settings (WF-20817CD).
   Dressler EV, Weaver KE, Sutfin EL, Bellinger C, et al · · 2025 · PMID 40694048 · DOI 10.1158/1055-9965.epi-25-0293
7. Proceedings of the 16th Annual Conference on the Science of Dissemination and Implementation in Health
   · 2024
8. Practical design considerations for cluster randomized controlled trials: lessons learned in community oncology research.
   Dressler EV, Pugh SL, Gunn HJ, Unger JM, et al · · 2025 · PMID 39989035 · DOI 10.1093/jncimonographs/lgae053