A Study of Patient-reported Outcomes in Patients With Lung or Esophageal Cancer

This survey study is looking to determine if patient reported outcomes(using the PROMIS survey) will vary according to the presence of recurrent or metastatic lung or esophageal cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

A patient-centered approach to lung cancer surveillance following resection needs to incorporate patient reported outcomes. The Patient Reported Outcomes Measurement Information System (PROMIS®) was designed to revolutionize the assessment of patient reported outcomes by establishing a national resource for the measurement of patient-reported symptoms and other health outcomes.

The PROMIS Assessment Center, the management tool within the larger PROMIS system, will be used to securely store de identified data, provide automated accrual reports and data export for this specific study. This study will have it's own study specific website.

Patients seen at the University of Virginia Cancer Center will be identified and invited to participate in an assessment of their reported outcomes over multiple domains available in PROMIS. Collecting this information on lung cancer survivors may provide a robust platform to design a patient-centered surveillance strategy following resection.

The study team hypothesizes that patient reported outcomes will vary according to the presence of recurrence or metastasis of lung or esophageal cancer. The study team also believes including patient reported outcomes into routine post-treatment surveillance will improve patient satisfaction and improve outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

≥18 years of age
Suspected or Known diagnosis of lung or esophageal cancer
Willing and able to complete questionnaires

Exclusion criteria

Subjects unwilling to provide informed consent
Subjects unwilling or unable to answer the questionnaires

Treatment and study plan

Primary outcomes

Patient Reported Outcomes Measurement Information System (PROMIS) Scores.

Time frame: Over a 3 year period

Enrolled subjects with lung or esophageal cancer will be asked to complete an on-line (web-based) survey (PROMIS) using a computer. Most patients will only be asked to complete this survey once, but some patients will be asked to answer the questions a second or third time over a maximum five year period. The PROMIS assessment center was used to develop and administer patient reported outcomes (PROs) for each of these five cancer domains. PROMIS scores are continuous and range from 0-100. Total scores were calculated and calibrated to the weighted distribution of scores from a large representative sample of the U.S. general population using the 'T-score' algorithm 18. The T-scores for the study population are calibrated to the surveyed population mean of 50 and standard deviation of 10, such that a study patient with a T-score of 40 is one standard deviation below the U.S. general population mean.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

Alliance for Clinical Trials in Oncology
Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Sep 12, 2014
Registry last updated: Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed