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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA244433-03S3 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualitative Group Interviews | Other | One time interview, 60-90 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention Measure | Acceptability of Intervention Measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes | End of study, up to 16 weeks |
| Intervention Appropriateness Measure |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Gina Kruse, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massacusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 four times for 1-2 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Intervention Measure | Feasibility of Intervention Measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes | Posted | Median | Inter-Quartile Range | units on a scale | End of study, up to 16 weeks |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gina Kruse, PI | General Internal Medicine, University of Colorado School of | 303-724-4811 | gina.kruse@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2023 | Nov 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Stakeholder advisory group |
| Other |
The team will meet with the stakeholder advisory group four times for 1-2 hours each |
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Intervention appropriateness measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes
| End of study, up to 16 weeks |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Acceptability of Intervention Measure | Acceptability of Intervention Measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes | Posted | Median | Inter-Quartile Range | units on a scale | End of study, up to 16 weeks |
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| Secondary | Intervention Appropriateness Measure | Intervention appropriateness measure, 5-point Likert scales (range 1-5), higher values reflect favorable outcomes | Posted | Median | Inter-Quartile Range | units on a scale | End of study, up to 16 weeks |
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| 0 |
| 8 |
| 0 |
| 8 |
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| 8 |
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