Population at RiskPhase 3EQUALNCT05046951
Educating QUitline Callers About Lung Cancer Screening
A Phase 3 study testing Should I Screen website and Should I Screen print booklet in people with Population at Risk, run by Georgetown University at 1 site in United States.
Trial summary
The specific aims are: 1. To evaluate the potential barriers of providing educational lung screening interventions to quitline users, the investigators will seek input from 10-20 stakeholders on the newly adapted print version of the Should I Screen website, and on our proposed Aim 2 recruitment and retention… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Population at Risk
- What is being tested?
- Should I Screen website and Should I Screen print booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2021to 30 Jun 2022
- Phase
- Phase 3
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enrolled in the quitline
- 50-80 years old
- >20-pack year smoking history
- never screened or >12 months since prior screen
- English speaking
- able to provide meaningful consent
- no family members in the same household enrolled in the trial
Who cannot join
- prior lung cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Testing Methods to Increase Lung Cancer Screening Among Quitline Callers
The specific aims are:
- To evaluate the potential barriers of providing educational lung screening interventions to quitline users, the investigators will seek input from 10-20 stakeholders on the newly adapted print version of the Should I Screen website, and on our proposed Aim 2 recruitment and retention procedures.
- To conduct a randomized intervention, comparing: 1) ShouldIScreen.com website, (WEB; N=150); vs. 2) the Should I Screen print version (PRINT; N=150). H2.1. At 1- and 4-months post-randomization, the WEB arm will have significantly higher lung screening knowledge and intention to undergo lung screening, compared to PRINT. Randomization will be stratified by age and pack-years in order to incorporate those who are recently eligible for screening, ages 50-54 and with 20-29 pack years. H2.2 The investigators will explore several potential moderators (age and e-health literacy). For example, the investigators will explore whether older vs younger participants have differential knowledge outcomes when using the PRINT vs WEB interventions. H2.3 We will explore whether mediators (prior lung screening, current primary care provider, lung cancer perceived risk) positively affects knowledge and screening intentions.
- To evaluate reach (% of quitline users enrolled) and engagement (% who read the intervention materials) by study arm and subgroup (e.g., method of quitline access, age, e-health literacy).
Read the detailed description
Aim 1: The 30-45 minute qualitative interviews will obtain: 1) feedback on the print adaptation of the Should I Screen website (the investigators will send it in advance of the interview), 2) recommendations for effective recruitment and retention procedures in Aim 2, 3) feedback on methods to increase the likelihood that participants will enroll and engage with the interventions (e.g., whether to present the study information immediately following initial contact with the quitline or later), 4) ideas to increase the likelihood that participants will contact their providers for an appointment to discuss lung screening, and 5) feedback on the Aim 2 measures regarding feasibility and acceptability.
Aim 2: H2.1. At 1- and 4-months post-randomization, the WEB arm will have significantly higher lung screening knowledge and intentions to undergo lung screening, compared to PRINT. H2.2 Moderators include, age, e-health literacy. For example, the investigators expect that younger participants will have significantly increased knowledge in the WEB (vs PRINT) arm, whereas intervention arm will have less of an impact among the older participants. H2.3 Mediators (e.g., prior lung screening, current primary care provider, lung cancer perceived risk) will positively affect knowledge and screening intentions. Aim 3. To evaluate reach (% of quitline users enrolled) and engagement (% who read the intervention materials) by study arm and subgroup (e.g., age, e-health literacy). The investigators will assess the feasibility for widespread implementation of both interventions
- Conditions
- Population at Risk
- Being tested
- Should I Screen website, Should I Screen print booklet
- Keywords
- lung cancer, lung cancer screening
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Should I Screen websiteBehavioural
The Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening.
Should I Screen print bookletBehavioural
The Should I Screen print-based education will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Web arm | Active comparator | The Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening. Receives: Behavioral: Should I Screen website |
| Print Arm | Active comparator | The Should I Screen print-based education (included with this IRB protocol) will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer. Receives: Behavioral: Should I Screen print booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach of eligible quitline users
% of eligible quitline users enrolled in the trial;
Measured: baseline assessment
Intervention Engagement of eligible quitline users
WEB: electronic assessment of 1) logged on, 2) total time spent on website, 3) sections accessed; PRINT: self-reported time spent reading;
Measured: one month assessment
Satisfaction with the intervention materials.
Assessment of satisfaction with length, format, and content of the materials
Measured: one month assessment
Lung cancer screening knowledge
Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening
Measured: one month assessment
Lung cancer screening knowledge
Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening
Measured: four month assessment
Percentage of participants who intend to undergo lung cancer screening
Intent to undergo lung cancer screening
Measured: one month assessment
Percentage of participants who intend to undergo lung cancer screening
Intent to undergo lung cancer screening
Measured: four month assessment
Secondary outcomes (2)
Percentage of participants with an appointment for a shared decision making visit
Shared decision making appt, lung screening referral, completed lung scan.
Measured: one month assessment
Percentage of participants with an appointment for a shared decision making visit
Shared decision making appt, lung screening referral, completed lung scan.
Measured: four month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start27 May 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Population at RiskStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046951
- Sponsor's protocol ID
- STUDY00002708
- Acronym
- EQUAL
- Status last verified
- Mar 2023
- First submitted
- 8 Jun 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Interested researchers can email the corresponding author to request access to deidentified data. A data analyais plan and IRB approval will be required.
Publications
Webster M, Whealan J, Williams RM, Eyestone E, Le A, Childs J, Kao JY, Martin M, Wolfe S, Yang F, Hung PY, Lau YK, Luta G, Tammemagi M, Meza R, Taylor KL. The tobacco quitline setting as a teachable moment: The Educating Quitline Users About Lung (EQUAL) cancer screening randomized trial. Transl Behav Med. 2023 Sep 28;13(10):736-747. doi: 10.1093/tbm/ibad049.
PubMed 37616531
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Methods to Increase Lung Cancer Screening Among Quitline Callers
- ClinicalTrials.gov ID
- NCT05046951
- Acronym / sponsor ID
- EQUAL / STUDY00002708
- Conditions
- Population at Risk
- Keywords
- lung cancer, lung cancer screening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- American Lung Association
- Study start
- 27 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Sep 2021 (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.
The specific aims are:
- To evaluate the potential barriers of providing educational lung screening interventions to quitline users, the investigators will seek input from 10-20 stakeholders on the newly adapted print version of the Should I Screen website, and on our proposed Aim 2 recruitment and retention procedures.
- To conduct a randomized intervention, comparing: 1) ShouldIScreen.com website, (WEB; N=150); vs. 2) the Should I Screen print version (PRINT; N=150). H2.1. At 1- and 4-months post-randomization, the WEB arm will have significantly higher lung screening knowledge and intention to undergo lung screening, compared to PRINT. Randomization will be stratified by age and pack-years in order to incorporate those who are recently eligible for screening, ages 50-54 and with 20-29 pack years. H2.2 The investigators will explore several potential moderators (age and e-health literacy). For example, the investigators will explore whether older vs younger participants have differential knowledge outcomes when using the PRINT vs WEB interventions. H2.3 We will explore whether mediators (prior lung screening, current primary care provider, lung cancer perceived risk) positively affects knowledge and screening intentions.
- To evaluate reach (% of quitline users enrolled) and engagement (% who read the intervention materials) by study arm and subgroup (e.g., method of quitline access, age, e-health literacy).
Detailed description
Aim 1: The 30-45 minute qualitative interviews will obtain: 1) feedback on the print adaptation of the Should I Screen website (the investigators will send it in advance of the interview), 2) recommendations for effective recruitment and retention procedures in Aim 2, 3) feedback on methods to increase the likelihood that participants will enroll and engage with the interventions (e.g., whether to present the study information immediately following initial contact with the quitline or later), 4) ideas to increase the likelihood that participants will contact their providers for an appointment to discuss lung screening, and 5) feedback on the Aim 2 measures regarding feasibility and acceptability.
Aim 2: H2.1. At 1- and 4-months post-randomization, the WEB arm will have significantly higher lung screening knowledge and intentions to undergo lung screening, compared to PRINT. H2.2 Moderators include, age, e-health literacy. For example, the investigators expect that younger participants will have significantly increased knowledge in the WEB (vs PRINT) arm, whereas intervention arm will have less of an impact among the older participants. H2.3 Mediators (e.g., prior lung screening, current primary care provider, lung cancer perceived risk) will positively affect knowledge and screening intentions. Aim 3. To evaluate reach (% of quitline users enrolled) and engagement (% who read the intervention materials) by study arm and subgroup (e.g., age, e-health literacy). The investigators will assess the feasibility for widespread implementation of both interventions
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web arm | Active comparator | Behavioral: Should I Screen websiteThe Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening. |
| Print Arm | Active comparator | Behavioral: Should I Screen print bookletThe Should I Screen print-based education (included with this IRB protocol) will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- enrolled in the quitline
- 50-80 years old
- >20-pack year smoking history
- never screened or >12 months since prior screen
- English speaking
Key exclusion criteria (1 listed)
- prior lung cancer
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 |
|---|---|---|
| Should I Screen websiteThe Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening. | Behavioural | Web arm |
| Should I Screen print bookletThe Should I Screen print-based education will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer. | Behavioural | Print Arm |
Primary outcome
Reach of eligible quitline users
Time frame: baseline assessment
% of eligible quitline users enrolled in the trial;
Intervention Engagement of eligible quitline users
Time frame: one month assessment
WEB: electronic assessment of 1) logged on, 2) total time spent on website, 3) sections accessed; PRINT: self-reported time spent reading;
Satisfaction with the intervention materials.
Time frame: one month assessment
Assessment of satisfaction with length, format, and content of the materials
Lung cancer screening knowledge
Time frame: one month assessment
Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening
Lung cancer screening knowledge
Time frame: four month assessment
Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening
Percentage of participants who intend to undergo lung cancer screening
Time frame: one month assessment
Intent to undergo lung cancer screening
Percentage of participants who intend to undergo lung cancer screening
Time frame: four month assessment
Intent to undergo lung cancer screening
2 secondary outcomes
Percentage of participants with an appointment for a shared decision making visit
Time frame: one month assessment
Percentage of participants with an appointment for a shared decision making visit
Time frame: four month assessment
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 29 Mar 2023.
- Background: PubMed 37616531Webster M, Whealan J, Williams RM, Eyestone E, Le A, Childs J, Kao JY, Martin M, Wolfe S, Yang F, Hung PY, Lau YK, Luta G, Tammemagi M, Meza R, Taylor KL. The tobacco quitline setting as a teachable moment: The Educating Quitline Users About Lung (EQUAL) cancer screening randomized trial. Transl Behav Med. 2023 Sep 28;13(10):736-747. doi: 10.1093/tbm/ibad049.
- Individual participant dataSharing planned: Yes. Interested researchers can email the corresponding author to request access to deidentified data. A data analyais plan and IRB approval will be required.
Related trials for Population at Risk
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Not yet recruiting
Interpersonal Relational Role Analysis Group Therapy for Nursing Students at Risk of Internet Addiction
Internet Addiction
Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Recruiting
Elastography-based Brief Alcohol Intervention in Hospitalized Individuals
Alcoholic Liver Disease (ALD), Alcohol Use Disorder
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Should I Screen website and Should I Screen print booklet in people with Population at Risk, run by Georgetown University 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 7 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 29 Mar 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reach of eligible quitline users (time frame: baseline assessment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046951, which also lists 1 linked publication.
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 29 Mar 2023.