NCT06351085

Brief Summary

The purpose of this study is to further understand the factors involved in increasing lung cancer screening.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,869

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
7mo left

Started Nov 2022

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Nov 2022Dec 2026

Study Start

First participant enrolled

November 10, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

4.1 years

First QC Date

March 26, 2024

Last Update Submit

May 4, 2026

Conditions

Keywords

Lung Cancer Screening

Outcome Measures

Primary Outcomes (1)

  • Lung Cancer Screening

    The primary outcome is the proportion of patients aged 50-80 with a history of smoking who receive Lung Cancer Screening during the study period; this outcome will be measured in both intervention groups and the control group.

    156 Weeks

Secondary Outcomes (1)

  • Completion of Interviews with Staff and Patients

    156 Weeks

Study Arms (3)

Pre-Visit Planner (PVP)

OTHER

A Licensed Vocational Nurse (LVN) will verify patient smoking history and calculate pack years with the patient over the phone.

Behavioral: Pre-Visit Planner

Pre-Visit Planner (PVP) + MyChart

OTHER

A Licensed Vocational Nurse (LVN) will verify patient smoking history and calculate pack years with the patient over the phone. In addition, the patient will receive educational video through MyChart prior to an LVN calling.

Behavioral: Pre-Visit Planner + MyChart

Usual Care

NO INTERVENTION

Patients will receive usual care.

Interventions

The study is comparing the implementation of a Pre-Visit Planner to go through the shared decision making process.

Pre-Visit Planner (PVP)

The study is comparing the implementation of a Pre-Visit Planner to go through the shared decision making process as well as testing if watching educational videos about the Lung Cancer Screening (LCS) process prior to talking to an LVN will help with LCS uptake.

Pre-Visit Planner (PVP) + MyChart

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Interviews:
  • UC Davis Health Systems (UCDHS) primary care providers and clinic staff who provide services to patients ages 50-80.
  • Patients who are eligible for lung cancer screening.
  • Screening Intervention:
  • \- Patients ages 50-80 who have a history of smoking per review of their electronic medical record and who receive care at the following UCDH ambulatory care clinics: Ellison Ambulatory Care Clinic; Elk Grove; Midtown.

You may not qualify if:

  • Interviews:
  • Non-consenting patients and patients who do not speak English or Spanish
  • Patients aged 49 and younger
  • Non UCDHS primary care providers and clinic staff
  • Screening Intervention:
  • UCDHS patients who have already received Lung Cancer Screening
  • Patients with existing Cancer diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Biostatistician created a randomized table to allocate patient in either intervention 1 or 2.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Patients of the intervention clinics will be assigned one of two interventions: 1) Pre Visit Planner (PVP) or 2) PVP + patient education delivered via the MyUCDHealth patient web portal.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 8, 2024

Study Start

November 10, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations