Clinical Trial 18515

Cancer Type: Thoracic
Interventions:

Study Type: Other
Phase of Study: NA
Investigators:

  • Matthew Schabath

Overview

Study Title

Symptoms, Toxicity Prevalence and Quality of Life Benefit of Targeted Therapies and Immunotherapies in Lung Cancer Patients: An Observational Prospective Cohort Study within the Total Cancer Care Population

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, we 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.

Objective

The overall study objective is determine the toxicities/side effects to molecular targeted agents, immunotherapies, and combination of treatments in a clinical setting and to estimate the contribution of clinical factors and patient characteristics to these toxicities/side effects and to overall quality of life, both at the time of enrollment and longitudinally over six months of treatment. The rationale for such an objective is to further describe the patient impact of anti-cancer therapy for NSCLC in a clinical setting. Ultimately, if successful, this work may improve patient-physician treatment decisions so that the patient's personal treatment goals and quality of life have the highest chances of being fulfilled. Specific Aims: Aim 1. Evaluate side effects/toxicity prevalence in a clinical setting for treatment profiles that include FDA-approved molecular targeted agents, immunotherapies, and combinations of treatments. Aim 2. Evaluate patient-reported symptoms, function and quality of life longitudinally and assess if treatment protocol is associated with a clinically meaningful improvement in symptoms, function, and/or quality of life. Aim 3. Estimate the contribution of clinical factors and patient characteristics to side effects/toxicity, symptoms, and function (physical, psychological, social) and/or quality of life at baseline enrollment and during treatment.

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 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).