NCT02803333

Brief Summary

The Moffitt Cancer Center and PatientsLikeMe.com (PLM), an online patient community, are working together to better understand the patient's entire lung cancer experience, both inside and outside the doctor's office. By combining the data that is captured by their care team in the clinic with the data participants enter at their home on PatientsLikeMe.com, the investigators hope to improve patient-physician treatment decisions, so that the patient's personal treatment goals and quality of life have the highest chances of being fulfilled.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

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

June 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

February 16, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2018

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2021

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

June 14, 2016

Last Update Submit

February 24, 2023

Conditions

Lung CancerNon-small Cell Lung Cancer

Keywords

NSCLCCarcinoma, Non-Small-Cell LungLung DiseasesThoracic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Cancer Treatment Changes

    Clinical, molecular, and patient-reported data will be collected from participants. Participants will be asked if their treatment course has changed and, if so, what changes have occurred. These questions are primarily meant to identify the number of patients who were switched from one treatment regimen (e.g., chemotherapy) to either PD-1/PDL-1 inhibitor treatment (immunotherapy) or tyrosine kinase inhibitors (TKIs).

    6 months post enrollment

Study Arms (1)

Data Capture Participants

This is a prospective observational cohort study of advanced non-small cell lung cancer patients (stage 3b/4) receiving treatment at the Moffitt Cancer Center (MCC) or The Ohio State Comprehensive Cancer Center (OSUCCC) to assess treatment impact at monthly intervals from baseline to 6 months post-enrollment.

Other: No Intervention

Interventions

No InterventionOTHER

No intervention

Data Capture Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Advanced non-small cell lung cancer patients (stage 3b/4) receiving treatment at the Moffitt Cancer Center (MCC) or The Ohio State University Comprehensive Cancer Center (OSUCCC)

You may qualify if:

  • \>= 18 years of age
  • Diagnosed with metastatic (stage 3b/4) non-small cell lung cancer (NSCLC)
  • The total combined sample size must include at least 100 people who received one or more treatments of PD-1/PDL-1 inhibitor treatment (immunotherapy), and 50 patients who received an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI). Patients receiving any other treatments will be tracked for treatment outcomes, as well as to serve as comparison participants during data analyses of outcomes associated with PD-1/PDL-1 or EGFR-TKI).
  • Consented separately to the Total Cancer Care (TCC) protocol
  • Have access to the internet
  • Willing to enroll in the free online health tracking and patient community "PatientsLikeMe"

You may not qualify if:

  • Patients enrolled in Phase I clinical trial protocols
  • Patients enrolled in Phase II, III or IV clinical trials involving blinded therapies (patients in open label trials will be eligible)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungLung DiseasesThoracic Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Matthew Schabath, Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 16, 2016

Study Start

February 16, 2017

Primary Completion

August 18, 2018

Study Completion

November 19, 2021

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations

US(1)