NCT02705365

Brief Summary

To develop and implement a patient navigator (PN) program for lung screening and smoking cessation in community health center primary care practices. This program will be evaluated in a randomized controlled trial of primary care patients who currently smoke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2017

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 26, 2017

Completed
Last Updated

January 5, 2018

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

March 1, 2016

Results QC Date

August 29, 2017

Last Update Submit

December 14, 2017

Conditions

Lung Cancer

Keywords

Lung ScreeningLow-Dose Computer TomographyPatient Navigation

Outcome Measures

Primary Outcomes (1)

  • Chest CT Completion

    Percentage of patients assigned to the intervention and control groups who had at least one chest CT (according to billing and EMR data) during the 1-year study period.

    Up to 1 year

Secondary Outcomes (1)

  • Tobacco Treatment Use

    Up to 1 year

Study Arms (2)

Patient Navigation

EXPERIMENTAL

Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient's interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.

Other: Patient Navigation

Usual Care

ACTIVE COMPARATOR

The control group will receive usual care during the 1-year study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results as well as smoking cessation guidance.

Other: Usual Care

Interventions

Patient NavigationOTHER

One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.

Patient Navigation
Usual CareOTHER

Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.

Usual Care

Eligibility Criteria

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

You may qualify if:

  • adult patients aged 55-77 years who are current cigarette smokers (according to an algorithm using electronic medical record data), and
  • receive care at one of the five Massachusetts General Hospital community health centers.

You may not qualify if:

  • patients who have previously received a diagnosis of lung cancer,
  • have undergone a chest CT within 18 months before enrollment,
  • are subsequently identified as having died prior to the study intervention,
  • deemed by their primary care provider as not eligible for lung screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Percac-Lima S, Ashburner JM, Rigotti NA, Park ER, Chang Y, Kuchukhidze S, Atlas SJ. Patient navigation for lung cancer screening among current smokers in community health centers a randomized controlled trial. Cancer Med. 2018 Mar;7(3):894-902. doi: 10.1002/cam4.1297. Epub 2018 Feb 21.

    PMID: 29464877DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Sanja Percac-Lima, MD, PhD
Organization
Massachusetts General Hospital
spercaclima@partners.org
617-643-6980

Study Officials

  • Sanja Percac-Lima, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 10, 2016

Study Start

February 1, 2016

Primary Completion

January 31, 2017

Study Completion

February 7, 2017

Last Updated

January 5, 2018

Results First Posted

September 26, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)