Oncology Research Information Exchange Network (ORIEN) Lu... | NCT02803333

Studies
Oncology Research Information Exchange Network (ORIEN) Lung Cancer Study

NCT02803333

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Status

Completed

Last Update Posted

Feb 27, 2023Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Lung Cancer
Non-small Cell Lung Cancer

Interventions

No Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2017Actual

Primary Completion Date

Aug 18, 2018Actual

Completion Date

Nov 19, 2021Actual

First Submitted Date

Jun 14, 2016

First Submission Date that Met QC Criteria

Jun 15, 2016

First Posted Date

Jun 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2023

Last Update Posted Date

Feb 27, 2023Actual

Name	Class
PatientsLikeMe	OTHER
Ohio State University Comprehensive Cancer Center	OTHER
AstraZeneca	INDUSTRY
Genentech, Inc.

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The aim of the study is to assess the real-world patient experience by evaluating the patients' quality of life, treatment toxicities, and clinical measures over a 6-month period. The ultimate goal of this research is 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.

Aim 1. To track the toxicities/side-effects of FDA approved molecular targeted agents, immunotherapies, and combinations of treatments for NSCLC in a clinical setting for six months.

Aim 2. To assess the impact of these treatment regimens on patient toxicities, symptoms, function, and quality of life, after adjustment for clinical factors and patient characteristics during the 6 month follow-up period.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	No intervention	Data Capture Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>= 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"

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Schabath, Ph.D.	H. Lee Moffitt Cancer Center and Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
H. Lee Moffitt Cancer Center and Research Institute		Tampa	Florida	33612	United States

Label	URL
Moffitt Cancer Center Clinical Trials website	View source

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung
D008171	Lung Diseases
D013899	Thoracic Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided