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

NCT02239328 | Completed Results

• 1 other identifier: 17525
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Esophageal Cancer

Keywords

Lung cancer; esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcomes Measurement Information System (PROMIS) Scores.

  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.

  Over a 3 year period

Study Arms (1)

Lung Cancer, Esophageal Cancer

Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung cancer Esophageal cancer

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead
• Alliance for Clinical Trials in Oncology: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Benjamin Kozower
• Organization: Washington University

kozower@wustl.edu

314-362-8089

Study Officials

• Benjamin Kozower, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: September 12, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 26, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)