Esophageal Cancer, Lung Cancer
Conditions
Keywords
Lung cancer, esophageal cancer
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.
Interventions
None listed
Sponsors
Alliance for Clinical Trials in Oncology
Patient-Centered Outcomes Research Institute
University of Virginia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
There was no wash out or run-in period for this study. Subjects were consented and then immediately completed the survey.
Participants by arm
| Arm | Count |
|---|---|
| Lung Cancer, Esophageal Cancer Lung Cancer and Esophageal Cancer patients will complete the online PROMIS survey. No treatment intervention will be performed. | 174 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Benign disease noted at time of surgery | 6 |
| Overall Study | Equipment or website malfunction | 2 |
Baseline characteristics
| Characteristic | Lung Cancer, Esophageal Cancer |
|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 9.2 |
| Current smokers | 53 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 174 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 162 Participants |
| Region of Enrollment United States | 174 Participants |
| Sex: Female, Male Female | 92 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 174 |
| other Total, other adverse events | 0 / 174 |
| serious Total, serious adverse events | 0 / 174 |
Outcome results
Primary
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.
Time frame: Over a 3 year period
Population: All patients who completed at least 1 PROMIS survey who had a diagnosis of lung cancer.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lung Cancer, Esophageal Cancer | Patient Reported Outcomes Measurement Information System (PROMIS) Scores. | Physical Function | 43.05 units on a scale | Standard Deviation 8.57 |
| Lung Cancer, Esophageal Cancer | Patient Reported Outcomes Measurement Information System (PROMIS) Scores. | Anxiety | 51.51 units on a scale | Standard Deviation 9.27 |
| Lung Cancer, Esophageal Cancer | Patient Reported Outcomes Measurement Information System (PROMIS) Scores. | Depression | 48.64 units on a scale | Standard Deviation 8.68 |
| Lung Cancer, Esophageal Cancer | Patient Reported Outcomes Measurement Information System (PROMIS) Scores. | Fatigue | 50.74 units on a scale | Standard Deviation 9.66 |
| Lung Cancer, Esophageal Cancer | Patient Reported Outcomes Measurement Information System (PROMIS) Scores. | Pain | 51.45 units on a scale | Standard Deviation 9.37 |
p-value: <0.05ANOVA