Electronic Monitoring of Patient-Reported Outcomes and Function in GI Cancer Surgery: A Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Median time patients are able to tolerate wearing the wristband device, both before and after surgery
Study Overview
Brief Summary
This pilot clinical trial studies an electronic monitoring device of patient-reported outcomes (PROs) and function in improving patient-centered care in patients with gastrointestinal cancer undergoing surgery. Electronic monitoring is a technology-based way of asking patients about the quality of life, symptoms, and activity using online surveys and an activity tracking watch may make it easier for patients to tell their doctors and nurses about any issues before and after surgery. Electronic systems of assessing PROs may increase the depth and accuracy of available clinical data, save administrative time, prompt early intervention that improves the patient experience, foster patient-provider communication, improve patient safety, and enhance the consistency of data collection across multiple sites.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the feasibility of administration of electronic patient-reported outcomes and functional assessment in gastrointestinal (GI) cancer surgery (gastric, colorectal, liver, pancreas).
II. Determine percentage of patients able to complete > 80% of MD. Anderson Symptom Inventory (MDASI) and European Quality of LIfe-5 Dimensions (EQ-5D) web-based surveys.
III. Determine percentage of patients able to wear the wristband device at least 1 week post-operatively.
IV. Determine length of time to complete the web-based surveys.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled to undergo surgery for primary or secondary gastric, colorectal, liver, or pancreas cancer
- •Able to read and understand English
- •Patients across all stages of disease
- •There are no restrictions related to performance status or life expectancy
- •This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent
Exclusion Criteria
- •Research participants who have no computer and internet access and/or do not use a computer even if one is present in the household
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Outcomes
Primary Outcomes
Median time patients are able to tolerate wearing the wristband device, both before and after surgery
Time Frame: Up to 1 month
Descriptive statistics will be used to describe the distribution of time (before and after surgery) a patient is able to wear the wristband device.
Percentage of patients who are able to complete the web-based questionnaires MDASI and EQ-5D
Time Frame: Up to 1 month
Descriptive statistics will be reported. Patients who complete at least 80% of all scheduled MDASI and EQ-5D questionnaires will be indicated as able to complete the web-based questionnaires. The true population proportion will be estimated with 95% confidence interval of half-width no more than 0.16.
Mean time to complete the web based questionnaires MDASI and EQ-5D, as well as the Self Geriatric Assessment Measure
Time Frame: Up to 1 month
Descriptive statistics will be used to describe the distribution of time to complete each assessment.
Median time to complete the web based questionnaires MDASI and EQ-5D, as well as the Self Geriatric Assessment Measure
Time Frame: Up to 1 month
Descriptive statistics will be used to describe the distribution of time to complete each assessment.
Percentage of patients who are able to wear the wristband device for at least 1 week post-operatively
Time Frame: Up to 1 week post-operatively
Estimated with 95% confidence interval of half-width no more than 16%.
Mean time patients are able to tolerate wearing the wristband device, both before and after surgery
Time Frame: Up to 1 month
Descriptive statistics will be used to describe the distribution of time (before and after surgery) a patient is able to wear the wristband device.
Secondary Outcomes
- Percentage of patients who did not enroll in the study-composite outcome of multiple measure listed(Up to 1 month)
- Feedback on length of surveys and timing of administration, as measured by responses from Satisfaction Tool(Up to 1 month)
- Ease of use of web-based surveys and wristband device, as measured by responses from Satisfaction Tool(Up to 1 month)
- Feedback on items in the web-based surveys that are distressing or difficult to comprehend, as measured by responses from Satisfaction Tool(Up to 1 month)
- Mean number of missing items within each questionnaire(Up to 1 month)
- Suggestions for items that were not covered but should be added, as measured by responses from Satisfaction Tool(Up to 1 month)