Trial Outcomes & Findings for A Study of Patient-reported Outcomes in Patients With Lung or Esophageal Cancer (NCT NCT02239328)

NCT ID: NCT02239328

Last Updated: 2018-10-26

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 182 participants
• Primary outcome timeframe: Over a 3 year period
• Results posted on: 2018-10-26

Participant Flow

Subjects were screened and recruited in the Thoracic surgery clinic during their appointments. Subject recruitment began on 08/20/2014 and was completed on 11/20/2015.

There was no wash out or run-in period for this study. Subjects were consented and then immediately completed the survey.

Participant milestones

Measure	Lung Cancer, Esophageal Cancer Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.
Overall Study STARTED	182
Overall Study COMPLETED	174
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Lung Cancer, Esophageal Cancer Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.
Overall Study Benign disease noted at time of surgery	6
Overall Study Equipment or website malfunction	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lung Cancer, Esophageal Cancer n=174 Participants Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.
Age, Continuous	66.8 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants
Sex: Female, Male Male	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	174 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	162 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	174 Participants n=5 Participants
Current smokers	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: Over a 3 year period

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

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.

Outcome measures

Measure	Lung Cancer, Esophageal Cancer n=174 Participants Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed.
Patient Reported Outcomes Measurement Information System (PROMIS) Scores. Physical Function	43.05 units on a scale Standard Deviation 8.57
Patient Reported Outcomes Measurement Information System (PROMIS) Scores. Anxiety	51.51 units on a scale Standard Deviation 9.27
Patient Reported Outcomes Measurement Information System (PROMIS) Scores. Depression	48.64 units on a scale Standard Deviation 8.68
Patient Reported Outcomes Measurement Information System (PROMIS) Scores. Fatigue	50.74 units on a scale Standard Deviation 9.66
Patient Reported Outcomes Measurement Information System (PROMIS) Scores. Pain	51.45 units on a scale Standard Deviation 9.37

Adverse Events

Lung Cancer, Esophageal Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Benjamin Kozower

Washington University

Phone: 314-362-8089

Email: kozower@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place