Electronic Monitoring Device of Patient-Reported Outcomes and Function in Improving Patient-Centered Care in Patients With Gastrointestinal Cancer Undergoing Surgery
Study Details
Study Description
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:
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To determine the feasibility of administration of electronic patient-reported outcomes and functional assessment in gastrointestinal (GI) cancer surgery (gastric, colorectal, liver, pancreas).
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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.
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Determine percentage of patients able to wear the wristband device at least 1 week post-operatively.
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Determine length of time to complete the web-based surveys.
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Determine length of time patients are able to wear the wristband device, before and after surgery.
SECONDARY OBJECTIVES:
- Determine the percentage of patients who did not enroll in the study and analyze the reasons why. This will be accomplished using: 1) the number of patients asked to participate;
- the number of patients who declined to participate, and 3) reasons for declining participation.
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Responses from the Satisfaction Tool will be used to assess: 1) ease of use of web-based surveys and wristband device; 2) feedback on items in the web-based surveys that are distressing or difficult to comprehend; 3) feedback on length of surveys and timing of administration; and 4) suggestions for items that were not covered but should be added.
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Calculate the mean number of missing items within each questionnaire to identify individual or subsets of questions that are difficult to answer.
OUTLINE:
Patients complete online surveys comprising questions about quality of life, symptoms, and activity level, and wear a wristband device (Vivofit watch) 3-7 days prior to and after surgery. After going home, patients complete the symptom survey three times a week and quality of life survey once a week for 2 weeks post-surgery.
After completion of study, patients are followed up for 1 month.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Supportive Care (Vivofit watch, online surveys) Patients complete online surveys comprising questions about quality of life, symptoms, and activity level, and wear a wristband device (Vivofit watch) 3-7 days prior to and after surgery. After going home, patients complete the symptom survey three times a week and quality of life survey once a week for 2 weeks post-surgery. |
Other: Computer-Assisted Intervention
Complete online surveys
Device: Vivofit watch
Wear Vivofit watch
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Mean time patients are able to tolerate wearing the wristband device, both before and after surgery [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.
- Mean time to complete the web based questionnaires MDASI and EQ-5D, as well as the Self Geriatric Assessment Measure [Up to 1 month]
Descriptive statistics will be used to describe the distribution of time to complete each assessment.
- Median time patients are able to tolerate wearing the wristband device, both before and after surgery [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.
- Median time to complete the web based questionnaires MDASI and EQ-5D, as well as the Self Geriatric Assessment Measure [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 complete the web-based questionnaires MDASI and EQ-5D [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.
- Percentage of patients who are able to wear the wristband device for at least 1 week post-operatively [Up to 1 week post-operatively]
Estimated with 95% confidence interval of half-width no more than 16%.
Secondary Outcome Measures
- 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]
- Feedback on length of surveys and timing of administration, as measured by responses from Satisfaction Tool [Up to 1 month]
- Mean number of missing items within each questionnaire [Up to 1 month]
Mean number of missing items within each questionnaire will be calculated to identify individual or subsets of questions that are difficult to answer.
- Percentage of patients who did not enroll in the study-composite outcome of multiple measure listed [Up to 1 month]
Percentage of patients who did not enroll in the study will be determined and the reasons why will be analyzed. This will be accomplished using: i) the number of patients asked to participate, ii) the number of patients who declined to participate, and iii) reasons for declining participation.
- Suggestions for items that were not covered but should be added, as measured by responses from Satisfaction Tool [Up to 1 month]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Scheduled to undergo surgery for primary or secondary gastric, colorectal, liver, or pancreas cancer
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Able to read and understand English
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Patients across all stages of disease
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There are no restrictions related to performance status or life expectancy
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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:
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Research participants who have no computer and internet access and/or do not use a computer even if one is present in the household
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Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Medical Center | Duarte | California | United States | 91010 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Virginia Sun, City of Hope Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15051
- NCI-2015-01061
- 15051
- P30CA033572