Increasing Adherence to Lung Cancer Screening

NCT05832008 | Active Not Recruiting

• 2 other identifiers: UPCC 09522851056
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) \& diagnostic follow-up across eligible primary care clinicians \& patients. Following the trial, a subsample of patients \& clinicians will be invited to one-time semi-structured interview \& survey to identify individual \& system-level factors that may restrict or enhance the impact of strategies.

Conditions

Lung Cancer; Adherence, Patient

Keywords

Screening; Nudge; Adherence; Implementation science; Behavioral science; Digital health

Outcome Measures

Primary Outcomes (2)

• Number of completed annual LCS in patients with a negative baseline screen (Lung Imaging Reporting and Data System (Lung-RADS) 1 or 2).

  Number of completed low-dose computed tomography (LDCT) scans among adults who are due for annual screening based on evidence-based guidelines.

  Initial measurement will occur 3 months after randomization

• Number of completed recommended diagnostic follow-up scans or procedures in patients with a positive baseline screen (Lung-RADS 3 or 4a).

  Completion of recommended diagnostic follow-up scans or procedures among adults with positive baseline LDCT scan.

  Initial measurement will occur 3 months after randomization

Secondary Outcomes (1)

• Reach

  Initial measurement will occur 3 months after randomization

Other Outcomes (3)

• Rate of false-positive screens

  6 months after LDCT date

• Number of downstream imaging and diagnostic procedures

  6 months after LDCT date

• Number of lung cancer diagnoses

  6 months after LDCT date

Study Arms (4)

Clinician Nudge + Patient Nudge

EXPERIMENTAL

An EHR-prompt (pended order) will prompt clinicians in this arm when a patient is due for lung cancer screening or diagnostic follow-up. Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up

Behavioral: Patient Nudge; Behavioral: Clinician Nudge

Clinician Nudge Only

EXPERIMENTAL

Clinicians in this arm will not be prompted by a pended order when a patient is due for lung cancer screening or diagnostic follow-up. Patients will receive usual care.

Behavioral: Clinician Nudge

Patient Nudge Only

EXPERIMENTAL

Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up. Clinicians will receive usual care.

Behavioral: Patient Nudge

Usual care (no nudges)

NO INTERVENTION

Patients and clinicians in this arm will receive usual care.

Interventions

Patient Nudge BEHAVIORAL

Brief persuasive messaging to increase awareness about the importance of annual lung cancer screening and completion of recommended follow-up sent to patients via text message.

Clinician Nudge + Patient Nudge; Patient Nudge Only

Clinician Nudge BEHAVIORAL

EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.

Clinician Nudge + Patient Nudge; Clinician Nudge Only

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinicians will be eligible if they:
• are practicing primary care or specialty care physicians at a recruiting site within the University of Pennsylvania Health System;
• care for patients who completed LCS via LDCT in 2019-2023; and
• do not opt-out of study participation.
• Patients will be eligible if they:
• are eligible for LCS based on 2021 US Preventive Services Task Force (USPSTF) population guidelines (aged 50-80; smoking history of 20-pack years; smoked within the last 15 years)
• completed LCS via LDCT in 2019-2023;
• have not been diagnosed with lung cancer;
• meet criteria for non-adherence;
• remain eligible for LCS during the trial enrollment period; and
• receive LCS care from a clinician that has not opted-out of study participation

You may not qualify if:

• Patients will be excluded if they:
• a) have a highly suspicious baseline LDCT (Lung-RADS 4B/X) given the presence of existing clinical pathways to ensure adherence in this group

Sponsors & Collaborators

• National Comprehensive Cancer Network: collaborator
• AstraZeneca: collaborator
• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Patient Compliance

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Katharine Rendle, PhD,MSW,MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Anil Vachani, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: At the start of the trial, clinicians who do not opt-out will be randomized to the intervention (clinician nudge) or control arm (no clinician nudge). Eligible patients will be randomized, stratified by clinician, to either the intervention (patient nudge) or control group (no patient nudge).

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 27, 2023
• Study Start: October 18, 2023
• Primary Completion: August 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)