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Enrolling by Invitation

NCT Number: NCT07517692

Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening

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.

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Key information

Conditions

Lung Cancer Screening

Age range

50 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Primary care provider (PCP) participants:

Inclusion criteria

  • 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

Inclusion criteria

  • Adults between the ages of 50 and 77
  • 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

Exclusion criteria

  • 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)

Treatment and study plan

FIX-SDM

Behavioral

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 Care

Behavioral

PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice).

Patients will receive the usual care

Primary outcomes

  1. 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

Secondary outcomes

  1. Completion of LCS within 6 months

    Time frame: 6 months after the index visit

    The proportion of patients in each arm who completed LCS within 6 months of the index primary care visit

  2. LCS order

    Time frame: 3 and 6 months after the index visit

    The proportion of patients in each arm who had a LCS order in the electronic health record (EHR)

  3. LCS appointment

    Time frame: 3 and 6 months after the index visit

    The proportion of patients in each arm who had an appointment for LCS scheduled in the EHR

  4. Patient-reported LCS discussion

    Time frame: Within 10 days after the index visit

    The proportion of patients in each arm who had LCS discussions with providers during their visits, assessed by the patient survey items

  5. Content of LCS discussion

    Time frame: Within 10 days after the index visit

    The mean number of LCS topics discussed during the visits, assessed by the patient survey items in each arm

  6. Patient perceived quality of LCS discussion

    Time frame: Within 10 days after the index visit

    The mean score of the Patient Assessment of Cancer Communication Experiences (PACE) survey in each arm

  7. Patient-reported shared decsion making (SDM) for LCS

    Time frame: Within 10 days after the index visit.

    The mean score of the SDM Process 4, assessed during the patient survey in each arm

  8. Patient knowledge of LCS

    Time frame: Within 10 days after the index visit.

    The mean number of LCS knowledge question items answered correctly in each arm, assessed during the patient survey in each arm

  9. Patient decisional conflict

    Time frame: Within 10 days after the index visit and 3 months after the index visit

    The mean score of the Decisional Conflict Scale in each arm, assessed during the patient survey in each arm

  10. Patient acceptability of FIX-SDM

    Time frame: Within 10 days after the index visit.

    Acceptability of FIX-SDM among patients in the FIX-SDM arm, assessed by the survey items

  11. Patient decision satisfaction

    Time frame: 3 months after the index visit

    Patient decision satisfaction in each arm assessed by a 10-point Likert scale

  12. Patient decision regret

    Time frame: 3 months after the index visit

    Patient decision regret in each arm assessed by the Decision Regret Scale

  13. Patient decision intention to follow-up LCS

    Time frame: 3 months after the index visit

    Patient decision intention to adhere to follow-up LCS in each arm, assessed by a 5-point Likert scale

  14. Provider acceptability of FIX-SDM

    Time frame: Immediately after the PCP intervention

    Acceptability of FIX-SDM among providers in the FIX-SDM arm, assessed by provider survey items

  15. Provider report on decision aid use

    Time frame: 6 months after the provider baseline survey

    Frequency of decision aid use measured by a 5-point Likert scale in each arm

  16. Provider reports on the content of the LCS discussion

    Time frame: 6 months after the provider baseline survey

    Frequency of the content of LCS discussion measured by a 5-point Likert scale in each arm

  17. Sustainability of shared decision making for LCS

    Time frame: 6 months after the provider baseline survey

    Sustainability of shared decision-making for LCS assessed by the Normalization Measure Development Questionnaire in a provider survey in each arm

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: FIX-SDM LCS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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