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

NCT07517692 | Enrolling By Invitation

• 2 other identifiers: STUDY000011075K08CA283304
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Cancer Screening

Keywords

Shared Decision Making; Lung Cancer Screening; health informatics

Outcome Measures

Primary Outcomes (1)

• 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

  3 months after the index visit

Secondary Outcomes (17)

• Completion of LCS within 6 months

  6 months after the index visit

• LCS order

  3 and 6 months after the index visit

• LCS appointment

  3 and 6 months after the index visit

• Patient-reported LCS discussion

  Within 10 days after the index visit

• Content of LCS discussion

  Within 10 days after the index visit

Study Arms (2)

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.

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.

Behavioral: Usual Care

Interventions

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.

FIX-SDM

Usual Care BEHAVIORAL

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

Comparator: Usual Care

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PCPs (physicians or advanced practitioners)
• Who practice in general internal medicine or family medicine clinics in UMass Memorial Health

You may not qualify if:

• Participation in the previous study to co-develop the provider intervention (to avoid bias)
• Patient participants
• 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
• 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)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

Study Officials

• Mayuko Ito Fukunaga, MD, MSc

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: A cluster-randomized pilot study randomized at the PCP level (patient allocation clustered with PCP)

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 8, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)