Electronic Monitoring Device of Patient-Reported Outcomes and Function in Improving Patient-Centered Care in Patients With Gastrointestinal Cancer Undergoing Surgery
NCT ID: NCT02511821
Last Updated: 2021-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2015-07-22
2016-07-31
Brief Summary
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Detailed Description
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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.
V. Determine length of time patients are able to wear the wristband device, before and after surgery.
SECONDARY OBJECTIVES:
I. 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; 2) the number of patients who declined to participate, and 3) reasons for declining participation.
II. 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.
III. 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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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.
Computer-Assisted Intervention
Complete online surveys
Vivofit watch
Wear Vivofit watch
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Computer-Assisted Intervention
Complete online surveys
Vivofit watch
Wear Vivofit watch
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Virginia Sun
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2015-01061
Identifier Type: REGISTRY
Identifier Source: secondary_id
15051
Identifier Type: OTHER
Identifier Source: secondary_id
15051
Identifier Type: -
Identifier Source: org_study_id
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