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Designing an Implementation Strategy for Lung Screening and Smoking Cessation Treatment in Community Health Centers

A Systematic Approach to Designing an Implementation Strategy to Increase Lung Cancer Screening and Smoking Cessation Treatment Among Federally Qualified Community Health Center Patients Who Smoke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05447897
Acronym
SAILS-FQHC
Enrollment
9
Registered
2022-07-07
Start date
2022-12-01
Completion date
2023-05-31
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Brief summary

Tobacco use is the leading preventable cause of death in the US and a major driver of health disparities. Among our tools for reducing the harms of tobacco is lung cancer screening (LCS). This study will combine a review of existing qualitative and quantitative data on barriers to lung cancer screening and smoking cessation in underserved populations, a quantitative analysis of predictors of lung cancer screening and smoking cessation treatment use among Massachusetts Federally Qualified Health Centers (FQHC)s, and a stakeholder advisory group to synthesize these data and select implementation strategies that reflects the critical determinants and the strengths and resource constraints of the Federally Qualified Health Centers (FQHC) context.

Detailed description

Aim 1) To design an implementation strategy that targets critical components in the delivery of SCT or LCS services for patients who smoke. Aim 2) To assess the acceptability, appropriateness and feasibility of the implementation strategy among community health center staff.

Interventions

OTHERQualitative Group Interviews

One time interview, 60-90 minutes

OTHERStakeholder advisory group

The team will meet with the stakeholder advisory group four times for 1-2 hours each

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

FQHC implementation team including staff in the intervention FQHCs and their lung screening partners

Exclusion criteria

FQHC staff or partners who leave the organization before end of study

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Intervention MeasureEnd of study, up to 16 weeksFeasibility of Intervention Measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes

Secondary

MeasureTime frameDescription
Acceptability of Intervention MeasureEnd of study, up to 16 weeksAcceptability of Intervention Measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes
Intervention Appropriateness MeasureEnd of study, up to 16 weeksIntervention appropriateness measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes

Countries

United States

Participant flow

Participants by arm

ArmCount
Stakeholder Advisory Group
To co-design an implementation strategy that targets critical components in the delivery of SCT or LCS services for patients who smoke. Convene a stakeholder advisory group (CHC providers, quality improvement specialists, community engagement staff, and specialty providers) to review the results of the literature review and quantitative analysis of deidentified data in order to select a set of implementation strategies from a menu of strategies to implement. The team will meet with the stakeholder advisory group five to six times for 0.5-1 hours each. Qualitative Group Interviews: One time interview, 60-90 minutes Stakeholder advisory group: The team will meet with the stakeholder advisory group five to six times for 0.5-1 hours each
8
Total8

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDid not participate in survey2

Baseline characteristics

CharacteristicStakeholder Advisory Group
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
8 Participants
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
8 participants
Sex: Female, Male
Female
7 Participants
Sex: Female, Male
Male
1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 8
other
Total, other adverse events
0 / 8
serious
Total, serious adverse events
0 / 8

Outcome results

Primary

Feasibility of Intervention Measure

Feasibility of Intervention Measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes

Time frame: End of study, up to 16 weeks

ArmMeasureValue (MEDIAN)
Stakeholder Advisory GroupFeasibility of Intervention Measure4 units on a scale
Secondary

Acceptability of Intervention Measure

Acceptability of Intervention Measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes

Time frame: End of study, up to 16 weeks

ArmMeasureValue (MEDIAN)
Stakeholder Advisory GroupAcceptability of Intervention Measure4 units on a scale
Secondary

Intervention Appropriateness Measure

Intervention appropriateness measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes

Time frame: End of study, up to 16 weeks

ArmMeasureValue (MEDIAN)
Stakeholder Advisory GroupIntervention Appropriateness Measure4 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026