- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06681077
A Community Health Education Intervention for Increasing Community-driven Actions to Reduce the Cancer Burden in Western New York
I Can Join the Fight Against Cancer: An Intervention to Programmatically Build Grassroots Actions to Reduce the Cancer Burden
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
Phase I - Feasibility and Acceptability - 100 participants to be enrolled
- Examine the feasibility of the I CAN intervention. (Phase I)
- Examine the acceptability of the I CAN intervention. (Phase I)
- Examine topic areas selected for action within participants' I CAN plans for action. (Phase I)
Phase II - Effectiveness of intervention trial for Lung Cancer Screening - 400 participants to be enrolled
- Determine whether the I CAN intervention will result in higher number of individuals who complete lung cancer screening compared to didactic educational control. (Phase 2 [Effectiveness of intervention trial for lung cancer screening])
- Evaluate whether the I CAN intervention improves adherence to recommended annual lung cancer screening follow-up among participants who initially received low dose computed tomography of the chest (LDCT) screening. (Phase 2 [Effectiveness of intervention trial for lung cancer screening])
- Assess whether the I CAN intervention results in different levels of lung cancer screening knowledge and self-efficacy compared to the control group. (Phase 2 [Effectiveness of intervention trial for lung cancer screening])
OUTLINE:
Participants are assigned to 1 of 2 phases. Phase I - Participants attend an I CAN intervention workshop over 2 hours. Phase 2 - Community-based programs are randomized to 1 of 2 arms and participants are assigned to the arm to which their community-based program was randomized.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Principal Investigator:
- Elizabeth Bouchard
-
Contact:
- Elizabeth Bouchard
- Phone Number: 716-845-8357
- Email: Elizabeth.Bouchard@roswellpark.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being over 18 years old
- Able to participate in English
Exclusion Criteria:
- Unwilling or unable to follow protocol requirements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prevention (I CAN intervention) - Phase 1
Participants attend an I CAN intervention workshop over 2 hours.
|
Receive I CAN intervention
Other Names:
|
|
Experimental: I CAN Intervention - Phase 2
Participants attend an I CAN intervention workshop over 2 hours.
Two weeks after I CAN intervention workshop, participants receive a coaching call to assess progress, challenges, and revisions to I CAN plan.
|
Receive I CAN intervention
Other Names:
Receive coaching call
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demand - Phase 1
Time Frame: Up to 2 years
|
Feasibility will be assessed through demand, which will be evaluated as the number of people enrolled and the demographics of participants.
Descriptive analyses will be used.
|
Up to 2 years
|
|
Practicality - Phase 1
Time Frame: Up to 2 years
|
Practicality will be assessed through the percentage of participants who complete different aspects of the intervention.
Descriptive analyses will be used.
|
Up to 2 years
|
|
Lung Cancer Screening Uptake
Time Frame: Up to 2 years
|
Will be assessed by determining if I CAN intervention results in higher number of individuals who complete lung cancer screening
|
Up to 2 years
|
|
Acceptability- Phase 1
Time Frame: Up to 2 years
|
Acceptability will be examined through post-intervention measures, including the Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure.
Descriptive analyses will be used.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of follow up for Lung cancer screening
Time Frame: 6 months post screening (estimated to be 2 years)
|
6 months post screening (estimated to be 2 years)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung Cancer Screening knowledge - Phase 2
Time Frame: initial assessment and 6 months post screening (estimated to be up to 2 years)
|
Will be compared between arms using an 8 item survey of True/False questions
|
initial assessment and 6 months post screening (estimated to be up to 2 years)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth Bouchard, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- I 4186824 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2024-09012 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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