NCT02962115

Brief Summary

This study evaluates the feasibility of a clinical informatics system-based approach to lung cancer screening. Patients of a large academic medical center who may qualify for lung cancer screening will be sent an electronic invitation to complete an online lung cancer screening decision aid.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

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

First Submitted

Initial submission to the registry

October 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

October 19, 2016

Last Update Submit

February 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Receipt of LDCT screening

    Number of participants who received a low-dose chest CT

    120 days

Secondary Outcomes (6)

  • Read portal invitation

    120 days

  • Visit web decision aid

    120 days

  • Complete web decision aid

    120 days

  • Eligible for LDCT

    120 days

  • Interest in LDCT screening

    120 days

  • +1 more secondary outcomes

Study Arms (1)

Decision Aid Invitation

EXPERIMENTAL

Electronic invitation to complete a web-based lung cancer screening decision aid

Behavioral: Decision Aid Invitation

Interventions

electronic invitation to complete web-based decision aid

Decision Aid Invitation

Eligibility Criteria

Age55 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has an active patient portal account
  • Scheduled to see a Wake Forest primary care provider within the next 4 weeks

You may not qualify if:

  • Never smokers
  • Current or former history of lung cancer
  • Receipt of chest CT scan within last 12 months
  • Need for a language interpreter
  • Presence of disease predicting short life-expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Dharod A, Bellinger C, Foley K, Case LD, Miller D. The Reach and Feasibility of an Interactive Lung Cancer Screening Decision Aid Delivered by Patient Portal. Appl Clin Inform. 2019 Jan;10(1):19-27. doi: 10.1055/s-0038-1676807. Epub 2019 Jan 9.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • David P Miller, MD, MS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2016

First Posted

November 11, 2016

Study Start

November 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share