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

NCT05447897 | Completed Results

• 2 other identifiers: 22-215P50CA244433-03S3
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Feasibility of Intervention Measure

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

  End of study, up to 16 weeks

Secondary Outcomes (2)

• Acceptability of Intervention Measure

  End of study, up to 16 weeks

• Intervention Appropriateness Measure

  End of study, up to 16 weeks

Study Arms (1)

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.

Other: Qualitative Group Interviews; Other: Stakeholder advisory group

Interventions

Qualitative Group Interviews OTHER

One time interview, 60-90 minutes

Stakeholder Advisory Group

Stakeholder advisory group OTHER

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

Stakeholder Advisory Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massacusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Gina Kruse, PI
• Organization: General Internal Medicine, University of Colorado School of

gina.kruse@cuanschutz.edu

303-724-4811

Study Officials

• Gina Kruse, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 7, 2022
• Study Start: December 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)