NCT03107156

Brief Summary

The overarching objective of this study is to close clinical knowledge and performance gaps by providing oncology clinicians with the latest advances and emerging research in the evidence-base and personalized treatment of advanced NSCLC patients. In addition, the research team seeks to meet quality measures relevant to value-based care delivery through IT infrastructure and clinical workflow processes. The research team also hopes to gain insights on clinician practice patterns related to advanced NSCLC, and the correlation between advanced NSCLC patients reported goals of care and advanced NSCLC patients' fit/frailty status and treatment decisions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

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

First Submitted

Initial submission to the registry

March 30, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

March 30, 2017

Last Update Submit

August 23, 2019

Conditions

Keywords

Treatment care planning

Outcome Measures

Primary Outcomes (1)

  • Adherence (by providers) to evidence-based treatment recommendations for patients with advanced NSCLC

    Data collected on the Carevive CPS will be analyzed in order to correlate the patient biomarker testing results with treatment selections.

    Year 1

Secondary Outcomes (2)

  • Components of value-based NSCLC cancer care.

    Year 1

  • Clinical practice patterns in medical oncologists managing older patients with advanced NSCLC.

    Year 1

Other Outcomes (1)

  • ER utilization and hospitalization in elderly patients with lung cancer

    Year 1

Interventions

Carevive CPSBEHAVIORAL

This intervention will focus on the use of the Carevive CPS at the point of treatment decision making, enabling providers to deliver evidence-based and personalized treatment care plans to their NSCLC patients on active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROS) and clinical data, reported and generated by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is drive by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Diagnosis of NSCLC
  • Newly diagnosed, in need of a new line or therapy, or at a treatment decision making timepoint.
  • Must be able to understand English

You may not qualify if:

  • Any patient who cannot understand written or spoken English
  • Any prisoner and.or other vulnerable person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 11, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

April 30, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations