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

An observational study of Lung Cancer and Esophageal Cancer, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Esophageal Cancer
How many people: 182 participants
Where: 1 siteUnited States
Study dates: Aug 2014to 1 Jul 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Lung cancer Esophageal cancer

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia
Charlottesville, Virginia, 22908

Other trials in United States

About this study

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.

Read the 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.

Conditions: Lung Cancer, Esophageal Cancer
Keywords: Lung cancer, esophageal cancer
Medical subject headings: Lung Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02239328
Study group	Role	What they receive
Lung Cancer, Esophageal Cancer		Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Over a 3 year period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 20141 Jul 2017

First posted12 Sep 2014 (estimated)
Study startAug 2014
Primary completionJun 2017
Study completion1 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by University of VirginiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02239328
Sponsor's protocol ID: 17525
Status last verified: Jan 2018
First submitted: 20 Aug 2014
Last updated: 26 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Patient-reported Outcomes in Patients With Lung or Esophageal Cancer
ClinicalTrials.gov ID: NCT02239328
Acronym / sponsor ID: 17525
Conditions: Lung Cancer, Esophageal Cancer
Keywords: Lung cancer, esophageal cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: Alliance for Clinical Trials in Oncology, Patient-Centered Outcomes Research Institute
Study start: Aug 2014
Primary completion: Jun 2017 (actual)
Study completion: 1 Jul 2017 (actual)
First posted: 12 Sep 2014 (estimated)
Results: Posted 26 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Lung Cancer, Esophageal Cancer	–	–Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Lung cancer Esophageal cancer

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

Results and safety

Results posted to the registry on 26 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lung Cancer, Esophageal Cancer	182	174

Primary outcome: Patient Reported Outcomes Measurement Information System (PROMIS) Scores.

Time frame: Over a 3 year period. Mean (Standard Deviation). Unit: units on a scale

Measure	Lung Cancer, Esophageal Cancer n = 174
Physical Function	43.05 (8.57)
Anxiety	51.51 (9.27)
Depression	48.64 (8.68)
Fatigue	50.74 (9.66)
Pain	51.45 (9.37)

Lung Cancer, Esophageal Cancer: p <0.05, ANOVA

Population analysed: All patients who completed at least 1 PROMIS survey who had a diagnosis of lung cancer.

Adverse events

Time frame: Over a 3 year period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lung Cancer, Esophageal Cancer	0 of 174 (0%)	0 of 174 (0%)	0 of 174

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benjamin Kozower, MD principal investigator

University of Virginia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Esophageal Cancer, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Reported Outcomes Measurement Information System (PROMIS) Scores. (time frame: Over a 3 year period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02239328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.