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

NCT ID: NCT02239328

Last Updated: 2018-10-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lung Cancer, Esophageal Cancer

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Benjamin Kozower, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benjamin Kozower, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17525

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Survival Outcomes of Lung Cancer
NCT03647098 RECRUITING