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

Completed

• Conditions: Lung Cancer; Esophageal Cancer

• Registration Number: NCT02239328
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Primary Completion: 2017-06
• Study Completion: 2017-07-01
• Results First Submitted: 2017-07-13
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-08
• Last Update Submitted: 2018-01-08
• Results First Posted: 2018-10-26
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcomes Measurement Information System (PROMIS) Scores.	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.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States