Electronic Monitoring Device of Patient-Reported Outcomes and Function in Improving Patient-Centered Care in Patients With Gastrointestinal Cancer Undergoing Surgery

Not Applicable

Completed

• Conditions: Stage IA Gastric Cancer; Stage IIB Gastric Cancer; Stage IIC Colorectal Cancer; Stage IIIA Gastric Cancer; Stage IIIB Adult Liver Cancer; Stage IVA Colorectal Cancer; Stage I Adult Liver Cancer; Stage IIB Colorectal Cancer; Stage IIB Pancreatic Cancer; Stage IIIA Colorectal Cancer
• Interventions: Other: Computer-Assisted Intervention; Device: Vivofit watch; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT02511821
• Lead Sponsor: City of Hope Medical Center

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.

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.

Study Timeline

• Study First Submitted: 2015-06-26
• Study Start: 2015-07-22
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-30
• Primary Completion: 2016-07-31
• Study Completion: 2016-07-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (Vivofit watch, online surveys)	Computer-Assisted Intervention	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.
Supportive Care (Vivofit watch, online surveys)	Quality-of-Life Assessment	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.
Supportive Care (Vivofit watch, online surveys)	Questionnaire Administration	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.
Supportive Care (Vivofit watch, online surveys)	Vivofit watch	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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 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 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%.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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	Mean number of missing items within each questionnaire will be calculated to identify individual or subsets of questions that are difficult to answer.
Suggestions for items that were not covered but should be added, as measured by responses from Satisfaction Tool	Up to 1 month

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States