Smoking CessationSAILS-FQHCNCT05447897
Designing an Implementation Strategy for Lung Screening and Smoking Cessation Treatment in Community Health Centers
A study testing Qualitative Group Interviews and Stakeholder advisory group in people with Smoking Cessation, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Qualitative Group Interviews and Stakeholder advisory group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- FQHC implementation team including staff in the intervention FQHCs and their lung screening partners
Who cannot join
- FQHC staff or partners who leave the organization before end of study
Trial locations and contacts
1 site in 1 country.
United States1 site
Massacusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Qualitative Group Interviews, Stakeholder advisory group
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative Group InterviewsOther
One time interview, 60-90 minutes
Stakeholder advisory groupOther
The team will meet with the stakeholder advisory group four times for 1-2 hours each
| Study group | Role | What they receive |
|---|---|---|
| Stakeholder Advisory Group | Other | 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 four times for 1-2 hours each. Receives: Other: Qualitative Group Interviews; Other: Stakeholder advisory group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure
Feasibility of Intervention Measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes
Measured: End of study, up to 16 weeks
Secondary outcomes (2)
Acceptability of Intervention Measure
Acceptability of Intervention Measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes
Measured: End of study, up to 16 weeks
Intervention Appropriateness Measure
Intervention appropriateness measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes
Measured: End of study, up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Dec 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gina Kruse, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447897
- Sponsor's protocol ID
- 22-215
- Other IDs
- P50CA244433-03S3
- Acronym
- SAILS-FQHC
- Status last verified
- Mar 2024
- First submitted
- 29 Jun 2022
- Last updated
- 16 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05447897
- Acronym / sponsor ID
- SAILS-FQHC / 22-215
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Posted 16 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stakeholder Advisory Group | Other | Other: Qualitative Group Interviews, Other: Stakeholder advisory groupTo 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 four times for 1-2 hours each. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- FQHC implementation team including staff in the intervention FQHCs and their lung screening partners
Key exclusion criteria (1 listed)
- FQHC staff or partners who leave the organization before end of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative Group InterviewsOne time interview, 60-90 minutes | Other | Stakeholder Advisory Group |
| Stakeholder advisory groupThe team will meet with the stakeholder advisory group four times for 1-2 hours each | Other | Stakeholder Advisory Group |
Primary outcome
Feasibility of Intervention Measure
Time frame: End of study, up to 16 weeks
Feasibility of Intervention Measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes
2 secondary outcomes
Acceptability of Intervention Measure
Time frame: End of study, up to 16 weeks
Intervention Appropriateness Measure
Time frame: End of study, up to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Kruse, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative Group Interviews and Stakeholder advisory group in people with Smoking Cessation, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (time frame: End of study, up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.