Lung CancerNCT04007458
Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder
A study testing Letter and Community Health Worker Phone Call in people with Lung Cancer, run by Anne Conners at 1 site in United States.
Trial summary
This research study will test whether support from a Community Health Worker (CHW) to address barriers to annual LDCT screening will result in an increased number of patients who receive the annual screening as per the recommended standard of care compared to passive outreach using a reminder letter. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Letter and Community Health Worker Phone Call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 16 Dec 2019
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30 or more pack years of tobacco use
- If no longer using tobacco, no more than 15 years since last use
- At least 13 months since last low dose CT scan screening
Who cannot join
- Development of serious medical condition that would preclude treatment of lung cancer if found
- Death since baseline screen
Trial locations and contacts
1 site in 1 country.
About this study
This research study will test whether support from a Community Health Worker (CHW) to address barriers to annual LDCT screening will result in an increased number of patients who receive the annual screening as per the recommended standard of care compared to passive outreach using a reminder letter.
Read the detailed description
This research study is a randomized controlled trial comparing phone outreach by a trained Community Health Worker (CHW) following a reminder letter to the reminder letter alone for patients who are at least a month overdue to have a routine annual low dose CT scan (LDCT) screening for lung cancer. CHWs will be able to identify and address barriers to accessing screening for those patients randomized to that arm of the study. Outcomes that will be measured include scheduling and completing the LDCT as well as agreeing to a referral for tobacco treatment.
- Conditions
- Lung Cancer
- Being tested
- Letter, Community Health Worker Phone Call
- Keywords
- 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.
LetterBehavioural
MaineGeneral Radiology will generate a reminder letter about their need for an annual low dose CT scan to the subjects in this arm.
Community Health Worker Phone CallBehavioural
Patients will receive a phone call from community health worker, offering to help them overcome barriers to repeat annual screening and offering to help them schedule their screening.
| Study group | Role | What they receive |
|---|---|---|
| Letter | Active comparator | Patients will receive a letter reminding them that they are overdue for repeat annual screening. Receives: Behavioral: Letter |
| Community Health Worker phone call | Experimental | Patients will receive a phone call from community health worker, offering to help them overcome barriers to repeat annual screening and offering to help them schedule their screening. Receives: Behavioral: Community Health Worker Phone Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completed low dose CT scan
Percentage of patients who receive low dose CT scan within 3 months of the date on which they were initially contacted by letter
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Scheduled low dose CT scan
Percentage of patients who schedule a low dose CT scan within 3 months of the date on which they were initially contacted by letter
Measured: through study completion, an average of one year
Tobacco counseling
Percentage of current smokers in the CHW phone call arm who receive counseling about tobacco treatment
Measured: through study completion, an average of one year
Maine Tobacco Helpline Referral
Percentage of current smokers in the CHW phone call arm who accept referral to Maine Tobacco Helpline
Measured: trhough study compeltion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start16 Jul 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomly assigned to one of the following two groups: 1\. Control Group: o Annual reminder letter only 1. Intervention Group: 2. Annual reminder letter and Community Health Worker proactive outreach
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Conners
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne Conners, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007458
- Sponsor's protocol ID
- 1419555
- Status last verified
- Nov 2020
- First submitted
- 1 Jul 2019
- Last updated
- 30 Nov 2020
- 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 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder
- ClinicalTrials.gov ID
- NCT04007458
- Acronym / sponsor ID
- 1419555
- Conditions
- Lung Cancer
- Keywords
- Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Anne ConnersUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 5 Jul 2019 (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 research study will test whether support from a Community Health Worker (CHW) to address barriers to annual LDCT screening will result in an increased number of patients who receive the annual screening as per the recommended standard of care compared to passive outreach using a reminder letter.
Detailed description
This research study is a randomized controlled trial comparing phone outreach by a trained Community Health Worker (CHW) following a reminder letter to the reminder letter alone for patients who are at least a month overdue to have a routine annual low dose CT scan (LDCT) screening for lung cancer. CHWs will be able to identify and address barriers to accessing screening for those patients randomized to that arm of the study. Outcomes that will be measured include scheduling and completing the LDCT as well as agreeing to a referral for tobacco treatment.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients will be randomly assigned to one of the following two groups: 1. Control Group: o Annual reminder letter only 1. Intervention Group: 2. Annual reminder letter and Community Health Worker proactive outreach
| Arm | Type | Receives |
|---|---|---|
| Letter | Active comparator | Behavioral: LetterPatients will receive a letter reminding them that they are overdue for repeat annual screening. |
| Community Health Worker phone call | Experimental | Behavioral: Community Health Worker Phone CallPatients will receive a phone call from community health worker, offering to help them overcome barriers to repeat annual screening and offering to help them schedule their screening. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 30 or more pack years of tobacco use
- If no longer using tobacco, no more than 15 years since last use
- At least 13 months since last low dose CT scan screening
Key exclusion criteria (2 listed)
- Development of serious medical condition that would preclude treatment of lung cancer if found
- Death since baseline screen
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 |
|---|---|---|
| LetterMaineGeneral Radiology will generate a reminder letter about their need for an annual low dose CT scan to the subjects in this arm. | Behavioural | Letter |
| Community Health Worker Phone CallPatients will receive a phone call from community health worker, offering to help them overcome barriers to repeat annual screening and offering to help them schedule their screening. | Behavioural | Community Health Worker phone call |
Primary outcome
Completed low dose CT scan
Time frame: through study completion, an average of 1 year
Percentage of patients who receive low dose CT scan within 3 months of the date on which they were initially contacted by letter
3 secondary outcomes
Scheduled low dose CT scan
Time frame: through study completion, an average of one year
Tobacco counseling
Time frame: through study completion, an average of one year
Maine Tobacco Helpline Referral
Time frame: trhough study compeltion, an average of one 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 30 Nov 2020.
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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. 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 study testing Letter and Community Health Worker Phone Call in people with Lung Cancer, run by Anne Conners 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 3 inclusion and 2 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 30 Nov 2020. 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?
Completed low dose CT scan (time frame: through study completion, an average of 1 year). 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 30 Nov 2020.