Lung CancerCHATSNCT07168629
A Community Health Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers
A study testing Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation and Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation in people with Lung Cancer and Tobacco Use, run by Baystate Medical Center at 1 site in United States.
Trial summary
Lung cancer screening (LCS) can reduce lung cancer-related mortality, but screening uptake remains low among eligible individuals. The goal of this study is to partner with community stakeholders to develop and pilot test a multi-component navigator-delivered intervention targeting key barriers to lung cancer… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Tobacco Use
- What is being tested?
- Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation and Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2026to 1 Aug 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between the age of 50 and 80.
- Potentially eligible for LCS according to the Electronic Health Record smoking history.
- Receive their primary care at Mason Square, High Street, or Brightwood community health centers.
- English- or Spanish- speaking.
Who cannot join
- Not eligible for lung cancer screening based on age (age < 50 or > 80 years) or smoking history (has not smoked more than 20 pack-years of tobacco cigarettes or quit more than 15 years ago).
- Have received a lung cancer screen in the past.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chisom Unegbu, BS contact
United States1 site, 1 recruiting
- Recruiting
Baystate Health
Springfield, Massachusetts, 01107
About this study
Lung cancer screening (LCS) can reduce lung cancer-related mortality, but screening uptake remains low among eligible individuals. The goal of this study is to partner with community stakeholders to develop and pilot test a multi-component navigator-delivered intervention targeting key barriers to lung cancer screening and tobacco treatment utilization. Participants are randomized to enhanced usual care, a community health worker (CHW)-delivered intervention, or the same intervention delivered by a trained lay navigator. The intervention includes patient outreach, patient-centered shared decision-making, tobacco treatment counseling, and assistance navigating logistical barriers to care. The proposed activities will lay the groundwork for a subsequent fully powered randomized clinical trial evaluating CHW- and lay navigator-delivered approaches to facilitate access to lung cancer screening and tobacco treatment.
Read the detailed description
Lung cancer is a leading cause of cancer death, and lung cancer screening (LCS) with low-dose computed tomography can reduce lung cancer-related mortality among eligible individuals. However, uptake of LCS remains low, particularly among populations that face barriers to accessing preventive care.
Community health worker (CHW) interventions have been effective at promoting screening and reducing barriers to care in other cancer settings. This study was designed to develop and pilot test a multi-component intervention intended to improve LCS uptake and tobacco treatment utilization. The intervention includes four components: 1) patient outreach, 2) patient-centered shared decision-making about lung cancer screening, 3) tobacco treatment counseling for participants who currently smoke, and 4) navigation of logistical barriers to care.
The intervention was developed in partnership with a community advisory board composed of community stakeholders and individuals with lived experience, using principles from the Transcreation Framework for Community-Engaged Behavioral Interventions.
The pilot randomized controlled trial is being conducted within Baystate Health community health centers. Participants are randomized to one of three study arms: 1) enhanced usual care, which includes mailed lung cancer screening educational materials and usual screening care through the participant's primary care provider; 2) the multi-component intervention delivered by a community health worker; or 3) the same multi-component intervention delivered by a trained lay navigator, such as a research assistant or pre-medical student.
The study will evaluate the feasibility of implementing the intervention using different navigator models. Primary pilot outcomes include participant recruitment, measure completion, retention, intervention fidelity, and acceptability. Secondary outcomes include lung cancer screening and tobacco treatment utilization. The study will also explore potential mechanisms through which the intervention may influence screening, including knowledge about lung cancer screening and assistance overcoming logistical barriers to care.
Findings from this pilot study will inform the design of a future, fully powered randomized controlled trial evaluating approaches to improving access to lung cancer screening and tobacco treatment.
- Conditions
- Lung Cancer, Tobacco Use
- Being tested
- Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation, Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation, Enhanced Usual Care
- Keywords
- lung cancer screening, tobacco treatment, community health workers, community health centers, Lay navigators
- Medical subject headings
- Lung Neoplasms, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigationBehavioural
The CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatmnet counseling, and 4) navigation of logistical barriers
Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigationBehavioural
The lay navigator will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers
Enhanced Usual CareOther
Participants will receive educational materials about lung cancer screening and usual lung cancer screening care through their primary care provider.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Active comparator | Partcipants will receive educational materials about lung cancer screening Receives: Other: Enhanced Usual Care |
| Community Health Worker-delivered Intervention | Experimental | Participants will receive a four-part intervention delivered by a community health worker to improve lung cancer screening uptake. The intervention includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers to care. Receives: Behavioral: Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation |
| Lay Navigator-delivered Intervention | Experimental | Participants will receive the same four-part intervention delivered by a trained lay navigator to improve lung cancer screening uptake. The intervention includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers to care. Receives: Behavioral: Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Number of participants at each stage of the recruitment and retention cascade
Counts abstracted from the study screening and enrollment log at each of the following stages: approached, screened eligible, consented, randomized, completed baseline data collection, and completed post-intervention follow-up assessment.
Measured: once a month until study trial ends, an average one year
Feasibility: Percentage of participants at each stage of the recruitment and retention cascade
Percentages calculated from the study screening and enrollment log. Eligibility rate = number screened eligible divided by number approached. Consent rate = number consented divided by number screened eligible. Randomization rate = number randomized divided by number consented. Baseline completion rate = number completing baseline data collection divided by number randomized. Retention rate = number completing post-intervention follow-up divided by number randomized.
Measured: once a month until study trial ends, an average one year
Fidelity: Duration in minutes of shared decision making (SDM) counseling per encounter
Time in minutes spent on SDM, recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.
Measured: once a month until study trial ends, an average of 1 year
Fidelity: Duration in minutes of smoking cessation counseling per encounter
Time in minutes spent on smoking cessation counseling,recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.
Measured: once a month until study trial ends, an average of 1 year
Fidelity - SDM quality using OPTION Scale Observer OPTION Scale
Mean total score on the OPTION Scale Observer OPTION Scale scored from audio-recorded SDM encounters; 12 items rated 0 ("not observed") to 4 ("exhibited at a very high standard"), total score 0-48, with higher scores indicating greater SDM competence.
Measured: once a month until study trial ends, an average of 1 year
Fidelity - Completion of SDM required elements
Mean count of CMS SDM Elements completed during each encounter: reduced lung cancer mortality, false positive, overdiagnosis, radiation exposure, annual screening, smoking cessation, follow-up testing, and diagnostic procedures.
Measured: once a month until study trial ends, an average of 1 year
Fidelity: Percentage of participants with documented use of the SDM decision aid
Proportion of participants for whom the SDM decision aid was used, documented in the CHW and lay navigator encounter log.
Measured: Monthly through study completion, an average of 1 year
Fidelity: Percentage of participants referred to tobacco treatment services, by type
Proportion referred to any tobacco treatment service by type (telephone quitline, in-person counseling,), from EHR referral orders and the CHW and lay navigator encounter log.
Measured: Monthly through study completion, an average of 1 year
Acceptability of the CHW and lay navigator intervention to participants
Qualitative themes regarding overall experience with the CHW and lay navigator intervention and barriers to lung cancer screening, identified through thematic analyses of semi-structured interviews using a study-specific interview guide. Participants (N=15), ~40-45 minutes, conducted in private at 3-month follow-up;
Measured: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)
Acceptability of the intervention to CHWs and Lay navigators
Qualitative themes regarding overall experience with the Naviagtor intervention and barriers to lung cancer screening, identified through thematic analysis of Navigator encounter logs and semi-structured interviews using a study-specific interview guide. Navigators (N=3), one 45-minute interview each after final intervention delivery.
Measured: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)
Secondary outcomes (5)
Percentage of participants with a lung cancer screening (LCS) referral order
Proportion of participants with an order placed in the electronic health record referring them to the LCS program, abstracted from EHR order data. Reported overall and by ordering source (community health worker vs. primary care provider).
Measured: 3 months post study enrollment
Percentage of participants completing low-dose CT lung cancer screening (LCS uptake)
Proportion of participants with a completed low-dose CT scan documented in the electronic health record, ascertained by EHR chart abstraction
Measured: Baseline and post intervention, 3 months post study enrollment
Percentage of participants initiating tobacco treatment, by treatment type
Proportion of participants initiating any tobacco treatment, and proportion by type (telephone quitline, in-person counseling, nicotine replacement therapy, prescription pharmacotherapy), ascertained by EHR chart abstraction and participant self-report at follow-up.
Measured: 3 months post study enrollment
Duration in weeks of tobacco treatment
Number of weeks of continuous tobacco treatment received, calculated from EHR pharmacy fill and counseling encounter data supplemented by participant self-report.
Measured: 3 months post study enrollment
Number of self-reported quit attempts per participant
Count of quit attempts lasting at least 24 hours, measured by participant self-report at the 3-month follow-up assessment.
Measured: 3 months post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start10 May 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Eduardo, Baystate Medical Center
- Investigators
- Jennifer Pacheco, Study director, Baystate Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168629
- Sponsor's protocol ID
- 2151088-4
- Other IDs
- 1K08CA289097-01
- Acronym
- CHATS
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing qualitative data such as transcriptions from interviews can potentially reveal sensitive information and identify individual participants. The higher level of redaction needed to remove potentially-identifying and sensitive information would substantially reduce the utility of transcripts in future analyses.To ensure this group's participation and honest responses, we will not share transcripts or coding summaries from participant or community health worker interviews. The goal of this pilot trial is to provide preliminary information to support a future fully powered randomized trial to address disparities in lung cancer in Black and Hispanic communities. Given that these community members have historically been subject to unethical research practices, we will limit the potential for further distrust by not sharing de-identified information outside of the study team or its collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Health Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers
- ClinicalTrials.gov ID
- NCT07168629
- Acronym / sponsor ID
- CHATS / 2151088-4
- Conditions
- Lung Cancer, Tobacco Use
- Keywords
- lung cancer screening, tobacco treatment, community health workers, community health centers, Lay navigators
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 May 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 11 Sep 2025 (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.
Lung cancer screening (LCS) can reduce lung cancer-related mortality, but screening uptake remains low among eligible individuals. The goal of this study is to partner with community stakeholders to develop and pilot test a multi-component navigator-delivered intervention targeting key barriers to lung cancer screening and tobacco treatment utilization. Participants are randomized to enhanced usual care, a community health worker (CHW)-delivered intervention, or the same intervention delivered by a trained lay navigator. The intervention includes patient outreach, patient-centered shared decision-making, tobacco treatment counseling, and assistance navigating logistical barriers to care. The proposed activities will lay the groundwork for a subsequent fully powered randomized clinical trial evaluating CHW- and lay navigator-delivered approaches to facilitate access to lung cancer screening and tobacco treatment.
Detailed description
Lung cancer is a leading cause of cancer death, and lung cancer screening (LCS) with low-dose computed tomography can reduce lung cancer-related mortality among eligible individuals. However, uptake of LCS remains low, particularly among populations that face barriers to accessing preventive care.
Community health worker (CHW) interventions have been effective at promoting screening and reducing barriers to care in other cancer settings. This study was designed to develop and pilot test a multi-component intervention intended to improve LCS uptake and tobacco treatment utilization. The intervention includes four components: 1) patient outreach, 2) patient-centered shared decision-making about lung cancer screening, 3) tobacco treatment counseling for participants who currently smoke, and 4) navigation of logistical barriers to care.
The intervention was developed in partnership with a community advisory board composed of community stakeholders and individuals with lived experience, using principles from the Transcreation Framework for Community-Engaged Behavioral Interventions.
The pilot randomized controlled trial is being conducted within Baystate Health community health centers. Participants are randomized to one of three study arms: 1) enhanced usual care, which includes mailed lung cancer screening educational materials and usual screening care through the participant's primary care provider; 2) the multi-component intervention delivered by a community health worker; or 3) the same multi-component intervention delivered by a trained lay navigator, such as a research assistant or pre-medical student.
The study will evaluate the feasibility of implementing the intervention using different navigator models. Primary pilot outcomes include participant recruitment, measure completion, retention, intervention fidelity, and acceptability. Secondary outcomes include lung cancer screening and tobacco treatment utilization. The study will also explore potential mechanisms through which the intervention may influence screening, including knowledge about lung cancer screening and assistance overcoming logistical barriers to care.
Findings from this pilot study will inform the design of a future, fully powered randomized controlled trial evaluating approaches to improving access to lung cancer screening and tobacco treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CarePartcipants will receive educational materials about lung cancer screening |
| Community Health Worker-delivered Intervention | Experimental | Behavioral: Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigationParticipants will receive a four-part intervention delivered by a community health worker to improve lung cancer screening uptake. The intervention includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers to care. |
| Lay Navigator-delivered Intervention | Experimental | Behavioral: Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigationParticipants will receive the same four-part intervention delivered by a trained lay navigator to improve lung cancer screening uptake. The intervention includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers to care. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults between the age of 50 and 80.
- Potentially eligible for LCS according to the Electronic Health Record smoking history.
- Receive their primary care at Mason Square, High Street, or Brightwood community health centers.
- English- or Spanish- speaking.
Key exclusion criteria (2 listed)
- Not eligible for lung cancer screening based on age (age < 50 or > 80 years) or smoking history (has not smoked more than 20 pack-years of tobacco cigarettes or quit more than 15 years ago).
- Have received a lung cancer screen in the past.
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 worker delivered outreach, shared decision-making, tobacco treatment, and navigationThe CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatmnet counseling, and 4) navigation of logistical barriers | Behavioural | Community Health Worker-delivered Intervention |
| Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigationThe lay navigator will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers | Behavioural | Lay Navigator-delivered Intervention |
| Enhanced Usual CareParticipants will receive educational materials about lung cancer screening and usual lung cancer screening care through their primary care provider. | Other | Enhanced Usual Care |
Primary outcome
Feasibility: Number of participants at each stage of the recruitment and retention cascade
Time frame: once a month until study trial ends, an average one year
Counts abstracted from the study screening and enrollment log at each of the following stages: approached, screened eligible, consented, randomized, completed baseline data collection, and completed post-intervention follow-up assessment.
Feasibility: Percentage of participants at each stage of the recruitment and retention cascade
Time frame: once a month until study trial ends, an average one year
Percentages calculated from the study screening and enrollment log. Eligibility rate = number screened eligible divided by number approached. Consent rate = number consented divided by number screened eligible. Randomization rate = number randomized divided by number consented. Baseline completion rate = number completing baseline data collection divided by number randomized. Retention rate = number completing post-intervention follow-up divided by number randomized.
Fidelity: Duration in minutes of shared decision making (SDM) counseling per encounter
Time frame: once a month until study trial ends, an average of 1 year
Time in minutes spent on SDM, recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.
Fidelity: Duration in minutes of smoking cessation counseling per encounter
Time frame: once a month until study trial ends, an average of 1 year
Time in minutes spent on smoking cessation counseling,recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.
Fidelity - SDM quality using OPTION Scale Observer OPTION Scale
Time frame: once a month until study trial ends, an average of 1 year
Mean total score on the OPTION Scale Observer OPTION Scale scored from audio-recorded SDM encounters; 12 items rated 0 ("not observed") to 4 ("exhibited at a very high standard"), total score 0-48, with higher scores indicating greater SDM competence.
Fidelity - Completion of SDM required elements
Time frame: once a month until study trial ends, an average of 1 year
Mean count of CMS SDM Elements completed during each encounter: reduced lung cancer mortality, false positive, overdiagnosis, radiation exposure, annual screening, smoking cessation, follow-up testing, and diagnostic procedures.
Fidelity: Percentage of participants with documented use of the SDM decision aid
Time frame: Monthly through study completion, an average of 1 year
Proportion of participants for whom the SDM decision aid was used, documented in the CHW and lay navigator encounter log.
Fidelity: Percentage of participants referred to tobacco treatment services, by type
Time frame: Monthly through study completion, an average of 1 year
Proportion referred to any tobacco treatment service by type (telephone quitline, in-person counseling,), from EHR referral orders and the CHW and lay navigator encounter log.
Acceptability of the CHW and lay navigator intervention to participants
Time frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)
Qualitative themes regarding overall experience with the CHW and lay navigator intervention and barriers to lung cancer screening, identified through thematic analyses of semi-structured interviews using a study-specific interview guide. Participants (N=15), ~40-45 minutes, conducted in private at 3-month follow-up;
Acceptability of the intervention to CHWs and Lay navigators
Time frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)
Qualitative themes regarding overall experience with the Naviagtor intervention and barriers to lung cancer screening, identified through thematic analysis of Navigator encounter logs and semi-structured interviews using a study-specific interview guide. Navigators (N=3), one 45-minute interview each after final intervention delivery.
5 secondary outcomes
Percentage of participants with a lung cancer screening (LCS) referral order
Time frame: 3 months post study enrollment
Percentage of participants completing low-dose CT lung cancer screening (LCS uptake)
Time frame: Baseline and post intervention, 3 months post study enrollment
Percentage of participants initiating tobacco treatment, by treatment type
Time frame: 3 months post study enrollment
Duration in weeks of tobacco treatment
Time frame: 3 months post study enrollment
Number of self-reported quit attempts per participant
Time frame: 3 months post study enrollment
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 22 Sep 2026.
- Individual participant dataSharing planned: No. Sharing qualitative data such as transcriptions from interviews can potentially reveal sensitive information and identify individual participants. The higher level of redaction needed to remove potentially-identifying and sensitive information would substantially reduce the utility of transcripts in future analyses.To ensure this group's participation and honest responses, we will not share transcripts or coding summaries from participant or community health worker interviews. The goal of this pilot trial is to provide preliminary information to support a future fully powered randomized trial to address disparities in lung cancer in Black and Hispanic communities. Given that these community members have historically been subject to unethical research practices, we will limit the potential for further distrust by not sharing de-identified information outside of the study team or its collaborators.
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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.
Chisom Unegbu, BS contact
Jennifer Pacheco study director
Baystate Health
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 worker delivered outreach, shared decision-making, tobacco treatment, and navigation and Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation in people with Lung Cancer and Tobacco Use, run by Baystate Medical Center 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 4 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: looking for participants now, as of the sponsor's last update on 22 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?
Contact Eduardo R Nunez, MD, MS (1-855-794-5864, Eduardo.nunez2@baystatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Number of participants at each stage of the recruitment and retention cascade (time frame: once a month until study trial ends, an average one 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 22 Sep 2026.