Lung CarcinomaNCT04635761
Awareness, Information, and Resources for Lung Cancer Screening Program for Community-Partnered Lung Cancer Screening
A study testing Educational Intervention and Questionnaire Administration in people with Lung Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This trial investigates an educational program called Awareness, Information, and Resources for Lung Cancer Screening Program in improving knowledge about lung cancer screening in medically underserved communities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Educational Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 25 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Members of all races and ethnic groups are eligible for this study
Who cannot join
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: The Roswell AIR (Awareness, Information and Resources for Lung Cancer Screening) Program: A Community-Partnered Lung Cancer Screening Intervention
This trial investigates an educational program called Awareness, Information, and Resources for Lung Cancer Screening Program in improving knowledge about lung cancer screening in medically underserved communities. This program aims to educate and remove barriers to lung cancer screening among medically underserved community members who are eligible for lung cancer screening, and to improve access to evidence-based screening guidelines for early detection for lung cancer in the Western New York area.
Read the detailed description
PRIMARY OBJECTIVES:
- Collaborate with community organizations and leaders to leverage community-based assets to disseminate education about lung cancer screening.
II. Reach medically underserved, high risk community members. III. Enhance lung cancer screening knowledge among medically underserved, high risk community members.
IV. Navigate screening-eligible community members to lung cancer screening.
OUTLINE:
Participants complete the Roswell Awareness, Information and Resources for Lung Cancer Screening (AIR) Program over 45 minutes and then receive the High-Risk Lung Cancer Tip Sheet.
- Conditions
- Lung Carcinoma
- Being tested
- Educational Intervention, Questionnaire Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Complete AIR Program and receive the High-Risk Lung Cancer Tip Sheet
Questionnaire AdministrationBehavioural
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Prevention (AIR Program) | Experimental | Participants complete the Roswell Awareness, Information and Resources for Lung Cancer Screening (AIR) Program over 45 minutes and then receive the High-Risk Lung Cancer Tip Sheet.. Receives: Behavioral: Educational Intervention; Behavioral: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of programs offered
Measured: Up to 1 year
Average number of attendees at each site
Measured: Up to 1 year
Demographics of attendees at each site
Measured: Up to 1 year
Number of medically underserved, high risk community members reached
Measured: Up to 1 year
Percent change in lung cancer screening awareness as assessed before and after program completion
Pre and post questionnaire to be given to participants
Measured: Up to 1 year
Percent change in knowledge of eligibility guidelines for screening as assessed before and after program completion
Pre and post questionnaire to be given to participants before and after educational sessions
Measured: Up to 1 year
Percent Change in knowledge of benefits of early detection as assessed before and after program completion
Pre and post questionnaire to be completed by participants before and after educational sessions
Measured: Up to 1 year
Change in fear, worry, and increased health-related self-efficacy
Pre and post questionnaire to be completed by participants before and after educational sessions
Measured: Up to 1 year
Number of screening eligible individuals reached
Measured: Up to 1 year
Number of screening eligible individuals navigated to lung cancer screening
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start30 Nov 2020
- Primary completion25 Aug 2021
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Bouchard, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635761
- Sponsor's protocol ID
- I 781020
- Other IDs
- NCI-2020-08297, I 781020
- Status last verified
- Sep 2022
- First submitted
- 5 Nov 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Roswell AIR (Awareness, Information and Resources for Lung Cancer Screening) Program: A Community-Partnered Lung Cancer Screening Intervention
- ClinicalTrials.gov ID
- NCT04635761
- Acronym / sponsor ID
- I 781020
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 19 Nov 2020 (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 trial investigates an educational program called Awareness, Information, and Resources for Lung Cancer Screening Program in improving knowledge about lung cancer screening in medically underserved communities. This program aims to educate and remove barriers to lung cancer screening among medically underserved community members who are eligible for lung cancer screening, and to improve access to evidence-based screening guidelines for early detection for lung cancer in the Western New York area.
Detailed description
PRIMARY OBJECTIVES:
- Collaborate with community organizations and leaders to leverage community-based assets to disseminate education about lung cancer screening.
II. Reach medically underserved, high risk community members. III. Enhance lung cancer screening knowledge among medically underserved, high risk community members.
IV. Navigate screening-eligible community members to lung cancer screening.
OUTLINE:
Participants complete the Roswell Awareness, Information and Resources for Lung Cancer Screening (AIR) Program over 45 minutes and then receive the High-Risk Lung Cancer Tip Sheet.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (AIR Program) | Experimental | Behavioral: Educational Intervention, Behavioral: Questionnaire AdministrationParticipants complete the Roswell Awareness, Information and Resources for Lung Cancer Screening (AIR) Program over 45 minutes and then receive the High-Risk Lung Cancer Tip Sheet.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Members of all races and ethnic groups are eligible for this study
Key exclusion criteria (1 listed)
- Adults unable to consent
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalComplete AIR Program and receive the High-Risk Lung Cancer Tip Sheet | Behavioural | Prevention (AIR Program) |
| Questionnaire AdministrationAncillary studies | Behavioural | Prevention (AIR Program) |
Primary outcome
Number of programs offered
Time frame: Up to 1 year
Average number of attendees at each site
Time frame: Up to 1 year
Demographics of attendees at each site
Time frame: Up to 1 year
Number of medically underserved, high risk community members reached
Time frame: Up to 1 year
Percent change in lung cancer screening awareness as assessed before and after program completion
Time frame: Up to 1 year
Pre and post questionnaire to be given to participants
Percent change in knowledge of eligibility guidelines for screening as assessed before and after program completion
Time frame: Up to 1 year
Pre and post questionnaire to be given to participants before and after educational sessions
Percent Change in knowledge of benefits of early detection as assessed before and after program completion
Time frame: Up to 1 year
Pre and post questionnaire to be completed by participants before and after educational sessions
Change in fear, worry, and increased health-related self-efficacy
Time frame: Up to 1 year
Pre and post questionnaire to be completed by participants before and after educational sessions
Number of screening eligible individuals reached
Time frame: Up to 1 year
Number of screening eligible individuals navigated to lung cancer screening
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Related trials for Lung Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
Recruiting
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
Lung Cancer
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.
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 Educational Intervention and Questionnaire Administration in people with Lung Carcinoma, 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 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 28 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of programs offered (time frame: Up to 1 year). The study lists 10 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 28 Sep 2022.