Lung Cancer ScreeningFIX-SDM LCSNCT07517692
Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening
A study testing FIX-SDM in people with Lung Cancer Screening, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. Read more about this study
- Who is it for?
- Ages 50 to 77 years
- Conditions the study is for
- Lung Cancer Screening
- What is being tested?
- FIX-SDM
- 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
- 7 Apr 2026to 1 Mar 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 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PCPs (physicians or advanced practitioners)
- Who practice in general internal medicine or family medicine clinics in UMass Memorial Health
- Who care for more than 5 potentially LCS-eligible patients in their practice Exclusion criteria
- Participation in the previous study to co-develop the provider intervention (to avoid bias)
- Patient participants
- Adults between the ages of 50 and 77
Show all 10Show fewer
- Meets criteria for Lung Cancer Screening (LCS) (Current eligibility includes: An individual who currently smokes or quit smoking within 15 years with at least a 20 pack-year smoking history)
- Has a smartphone with texting capability
- English-speaking
- Has a scheduled PCP visit in the next ~3-6 weeks from study enrollment with one of the PCP participants enrolled in the study
Who cannot join
- Prior LCS
- Chest CT within the last 12 months
- History of lung cancer
- Active cancer requiring treatment
- Supplemental oxygen use
- Pregnancy
- Participation in the previous study to co-develop the patient intervention (to avoid bias)
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
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
About this study
The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. The investigators will also assess the acceptability of the support program and the feasibility of the study protocol to prepare for a future large-scale trial. The main questions this trial aims to answer are:
- Does the patient and provider support increase the number of patients who complete lung cancer screening?
- Does the patient and provider support help patients and health care providers engage more in shared decision-making and improve the quality of the patient's decision regarding lung cancer screening?
- Is the study protocol feasible? The investigators will compare the patient and provider support program to usual care to see if the support increases the number of patients who complete lung cancer screening.
Read more
Primary care provider participants will:
- Receive the provider support session and educational materials, or follow usual practice
- Answer a baseline survey and a follow-up survey in 6 months
- Answer additional survey questions regarding the acceptability of the provider support session if they receive it
Patient participants will
- Receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit, or receive usual care
- Complete the baseline survey and two follow-up surveys, one right after the primary care visit and another 3 months after the visit.
Read the detailed description
Facilitation of Information eXchange for Shared Decision Making (FIX-SDM) for lung cancer screening is a multi-strategy implementation program designed to help patients eligible for lung cancer screening and their primary care providers (PCPs) prepare for shared decision-making (SDM). The investigators will conduct a cluster-randomized pilot study of FIX-SDM plus the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility (FIX-SDM arm), compared with the standard e-alert notification alone (usual care comparison arm).
The investigators hypothesized that, compared to the usual care comparison arm, more patients in the FIX-SDM arm will complete lung cancer screening 3 months after the primary care visit. This study will also provide feasibility data and preliminary results to help prepare for a future large-scale trial.
- Conditions
- Lung Cancer Screening
- Being tested
- FIX-SDM, Usual Care
- Keywords
- Shared Decision Making, Lung Cancer Screening, health informatics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIX-SDMBehavioural
Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system.
Patients receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit.
Usual CareBehavioural
PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice).
Patients will receive the usual care
| Study group | Role | What they receive |
|---|---|---|
| FIX-SDM | Experimental | Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system.
Patients will receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit. Receives: Behavioral: FIX-SDM |
| Comparator: Usual Care | Active comparator | PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Lung Cancer Screening (LCS) within 3 months
The proportion of patients in each arm who completed LCS within 3 months of the index primary care visit
Measured: 3 months after the index visit
Secondary outcomes (17)
Completion of LCS within 6 months
The proportion of patients in each arm who completed LCS within 6 months of the index primary care visit
Measured: 6 months after the index visit
LCS order
The proportion of patients in each arm who had a LCS order in the electronic health record (EHR)
Measured: 3 and 6 months after the index visit
LCS appointment
The proportion of patients in each arm who had an appointment for LCS scheduled in the EHR
Measured: 3 and 6 months after the index visit
Patient-reported LCS discussion
The proportion of patients in each arm who had LCS discussions with providers during their visits, assessed by the patient survey items
Measured: Within 10 days after the index visit
Content of LCS discussion
The mean number of LCS topics discussed during the visits, assessed by the patient survey items in each arm
Measured: Within 10 days after the index visit
Patient perceived quality of LCS discussion
The mean score of the Patient Assessment of Cancer Communication Experiences (PACE) survey in each arm
Measured: Within 10 days after the index visit
Patient-reported shared decsion making (SDM) for LCS
The mean score of the SDM Process 4, assessed during the patient survey in each arm
Measured: Within 10 days after the index visit.
Patient knowledge of LCS
The mean number of LCS knowledge question items answered correctly in each arm, assessed during the patient survey in each arm
Measured: Within 10 days after the index visit.
Patient decisional conflict
The mean score of the Decisional Conflict Scale in each arm, assessed during the patient survey in each arm
Measured: Within 10 days after the index visit and 3 months after the index visit
Patient acceptability of FIX-SDM
Acceptability of FIX-SDM among patients in the FIX-SDM arm, assessed by the survey items
Measured: Within 10 days after the index visit.
Patient decision satisfaction
Patient decision satisfaction in each arm assessed by a 10-point Likert scale
Measured: 3 months after the index visit
Patient decision regret
Patient decision regret in each arm assessed by the Decision Regret Scale
Measured: 3 months after the index visit
Patient decision intention to follow-up LCS
Patient decision intention to adhere to follow-up LCS in each arm, assessed by a 5-point Likert scale
Measured: 3 months after the index visit
Provider acceptability of FIX-SDM
Acceptability of FIX-SDM among providers in the FIX-SDM arm, assessed by provider survey items
Measured: Immediately after the PCP intervention
Provider report on decision aid use
Frequency of decision aid use measured by a 5-point Likert scale in each arm
Measured: 6 months after the provider baseline survey
Provider reports on the content of the LCS discussion
Frequency of the content of LCS discussion measured by a 5-point Likert scale in each arm
Measured: 6 months after the provider baseline survey
Sustainability of shared decision making for LCS
Sustainability of shared decision-making for LCS assessed by the Normalization Measure Development Questionnaire in a provider survey in each arm
Measured: 6 months after the provider baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start7 Apr 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster-randomized pilot study randomized at the PCP level (patient allocation clustered with PCP)
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mayuko Ito Fukunaga, University of Massachusetts, Worcester
- Investigators
- Mayuko Ito Fukunaga, MD, MSc, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517692
- Sponsor's protocol ID
- STUDY00001107
- Other IDs
- 5K08CA283304
- Acronym
- FIX-SDM LCS
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With an executed Data Use Agreement, a limited data set may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT07517692
- Acronym / sponsor ID
- FIX-SDM LCS / STUDY00001107
- Conditions
- Lung Cancer Screening
- Keywords
- Shared Decision Making, Lung Cancer Screening, health informatics
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 8 Apr 2026 (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 goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. The investigators will also assess the acceptability of the support program and the feasibility of the study protocol to prepare for a future large-scale trial. The main questions this trial aims to answer are:
- Does the patient and provider support increase the number of patients who complete lung cancer screening?
- Does the patient and provider support help patients and health care providers engage more in shared decision-making and improve the quality of the patient's decision regarding lung cancer screening?
- Is the study protocol feasible? The investigators will compare the patient and provider support program to usual care to see if the support increases the number of patients who complete lung cancer screening.
Primary care provider participants will:
- Receive the provider support session and educational materials, or follow usual practice
- Answer a baseline survey and a follow-up survey in 6 months
- Answer additional survey questions regarding the acceptability of the provider support session if they receive it
Patient participants will
- Receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit, or receive usual care
- Complete the baseline survey and two follow-up surveys, one right after the primary care visit and another 3 months after the visit.
Detailed description
Facilitation of Information eXchange for Shared Decision Making (FIX-SDM) for lung cancer screening is a multi-strategy implementation program designed to help patients eligible for lung cancer screening and their primary care providers (PCPs) prepare for shared decision-making (SDM). The investigators will conduct a cluster-randomized pilot study of FIX-SDM plus the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility (FIX-SDM arm), compared with the standard e-alert notification alone (usual care comparison arm).
The investigators hypothesized that, compared to the usual care comparison arm, more patients in the FIX-SDM arm will complete lung cancer screening 3 months after the primary care visit. This study will also provide feasibility data and preliminary results to help prepare for a future large-scale trial.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster-randomized pilot study randomized at the PCP level (patient allocation clustered with PCP)
| Arm | Type | Receives |
|---|---|---|
| FIX-SDM | Experimental | Behavioral: FIX-SDMPrimary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system. Patients will receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit. |
| Comparator: Usual Care | Active comparator | Behavioral: Usual CarePCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care. |
Who may qualify
- Ages
- 50 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- PCPs (physicians or advanced practitioners)
- Who practice in general internal medicine or family medicine clinics in UMass Memorial Health
- Who care for more than 5 potentially LCS-eligible patients in their practice Exclusion criteria
- Participation in the previous study to co-develop the provider intervention (to avoid bias)
- Patient participants
Key exclusion criteria (7 listed)
- Prior LCS
- Chest CT within the last 12 months
- History of lung cancer
- Active cancer requiring treatment
- Supplemental oxygen use
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 |
|---|---|---|
| FIX-SDMPrimary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system. Patients receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit. | Behavioural | FIX-SDM |
| Usual CarePCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care | Behavioural | Comparator: Usual Care |
Primary outcome
Completion of Lung Cancer Screening (LCS) within 3 months
Time frame: 3 months after the index visit
The proportion of patients in each arm who completed LCS within 3 months of the index primary care visit
17 secondary outcomes
Completion of LCS within 6 months
Time frame: 6 months after the index visit
LCS order
Time frame: 3 and 6 months after the index visit
LCS appointment
Time frame: 3 and 6 months after the index visit
Patient-reported LCS discussion
Time frame: Within 10 days after the index visit
Content of LCS discussion
Time frame: Within 10 days after the index visit
Patient perceived quality of LCS discussion
Time frame: Within 10 days after the index visit
Patient-reported shared decsion making (SDM) for LCS
Time frame: Within 10 days after the index visit.
Patient knowledge of LCS
Time frame: Within 10 days after the index visit.
Patient decisional conflict
Time frame: Within 10 days after the index visit and 3 months after the index visit
Patient acceptability of FIX-SDM
Time frame: Within 10 days after the index visit.
Patient decision satisfaction
Time frame: 3 months after the index visit
Patient decision regret
Time frame: 3 months after the index visit
Patient decision intention to follow-up LCS
Time frame: 3 months after the index visit
Provider acceptability of FIX-SDM
Time frame: Immediately after the PCP intervention
Provider report on decision aid use
Time frame: 6 months after the provider baseline survey
Provider reports on the content of the LCS discussion
Time frame: 6 months after the provider baseline survey
Sustainability of shared decision making for LCS
Time frame: 6 months after the provider baseline survey
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 7 Aug 2026.
- Individual participant dataSharing planned: Yes. With an executed Data Use Agreement, a limited data set may be shared.
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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.
Mayuko Ito Fukunaga, MD, MSc principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIX-SDM in people with Lung Cancer Screening, run by University of Massachusetts, Worcester 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 10 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 7 Aug 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?
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?
Completion of Lung Cancer Screening (LCS) within 3 months (time frame: 3 months after the index visit). 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 7 Aug 2026.