HealthyNCT06681077
A Community Health Education Intervention for Increasing Community-driven Actions to Reduce the Cancer Burden in Western New York
A study testing Community Health Education and Telephone Based Intervention in people with Healthy, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This clinical trial evaluates a community health education intervention (I CAN) for increasing community-driven actions to reduce the cancer burden in Western New York. Engaging community members is a critical component of designing impactful programs to reduce the cancer burden. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Community Health Education and Telephone Based Intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2024to 15 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Able to participate in English
Who cannot join
- Unwilling or unable to follow protocol requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Elizabeth Bouchard, 716-845-8357, Elizabeth.Bouchard@roswellpark.org
Elizabeth Bouchard
About this study
Official title: I Can Join the Fight Against Cancer: An Intervention to Programmatically Build Grassroots Actions to Reduce the Cancer Burden
This clinical trial evaluates a community health education intervention (I CAN) for increasing community-driven actions to reduce the cancer burden in Western New York. Engaging community members is a critical component of designing impactful programs to reduce the cancer burden. Leaders at the national, state, and local levels have all called for more community partnerships and engagement in design of health intervention and policies. The I CAN intervention is a workshop that includes a presentation outlining key concepts related to social network processes and the cancer burden in Western New York, a structured skill-building activity, and then empowering and motivating activities meant to cultivate momentum and excitement for action. This community health education intervention may be able to provide a formalized process for empowering and facilitating community members to take steps to reduce the community cancer burden.
Read the 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.
- Conditions
- Healthy
- Being tested
- Community Health Education, Telephone Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health EducationProcedure or surgery
Also called Community Education
Receive I CAN intervention
Telephone Based InterventionBehavioural
Receive coaching call
| Study group | Role | What they receive |
|---|---|---|
| Prevention (I CAN intervention) - Phase 1 | Experimental | Participants attend an I CAN intervention workshop over 2 hours. Receives: Procedure: Community Health Education |
| I CAN Intervention - Phase 2 | Experimental | 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. Receives: Procedure: Community Health Education; Behavioral: Telephone Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demand - Phase 1
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.
Measured: Up to 2 years
Practicality - Phase 1
Practicality will be assessed through the percentage of participants who complete different aspects of the intervention. Descriptive analyses will be used.
Measured: Up to 2 years
Acceptability- Phase 1
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.
Measured: Up to 2 years
Lung Cancer Screening Uptake
Will be assessed by determining if I CAN intervention results in higher number of individuals who complete lung cancer screening
Measured: Up to 2 years
Secondary outcomes (1)
Rate of follow up for Lung cancer screening
Measured: 6 months post screening (estimated to be 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start16 Nov 2024
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Elizabeth Bouchard, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681077
- Sponsor's protocol ID
- I 4186824
- Other IDs
- NCI-2024-09012, I 4186824
- Status last verified
- Sep 2026
- First submitted
- 1 Nov 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I Can Join the Fight Against Cancer: An Intervention to Programmatically Build Grassroots Actions to Reduce the Cancer Burden
- ClinicalTrials.gov ID
- NCT06681077
- Acronym / sponsor ID
- I 4186824
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Comprehensive Cancer Network
- Study start
- 16 Nov 2024 (actual)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates a community health education intervention (I CAN) for increasing community-driven actions to reduce the cancer burden in Western New York. Engaging community members is a critical component of designing impactful programs to reduce the cancer burden. Leaders at the national, state, and local levels have all called for more community partnerships and engagement in design of health intervention and policies. The I CAN intervention is a workshop that includes a presentation outlining key concepts related to social network processes and the cancer burden in Western New York, a structured skill-building activity, and then empowering and motivating activities meant to cultivate momentum and excitement for action. This community health education intervention may be able to provide a formalized process for empowering and facilitating community members to take steps to reduce the community cancer burden.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention (I CAN intervention) - Phase 1 | Experimental | Procedure: Community Health EducationParticipants attend an I CAN intervention workshop over 2 hours. |
| I CAN Intervention - Phase 2 | Experimental | Procedure: Community Health Education, Behavioral: Telephone Based InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being over 18 years old
- Able to participate in English
Key exclusion criteria (1 listed)
- Unwilling or unable to follow protocol requirements
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 |
|---|---|---|
| Community Health EducationAlso: Community EducationReceive I CAN intervention | Procedure or surgery | I CAN Intervention - Phase 2, Prevention (I CAN intervention) - Phase 1 |
| Telephone Based InterventionReceive coaching call | Behavioural | I CAN Intervention - Phase 2 |
Primary outcome
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.
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.
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.
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
1 secondary outcome
Rate of follow up for Lung cancer screening
Time frame: 6 months post screening (estimated to be 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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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.
Elizabeth Bouchard principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Education and Telephone Based Intervention in people with Healthy, run by Roswell Park Cancer Institute 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 2 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demand - Phase 1 (time frame: Up to 2 years). The study lists 4 primary outcomes in all. 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 4 Sep 2026.