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

January 5, 2021 updated by: City of Hope Medical Center

Electronic Monitoring of Patient-Reported Outcomes and Function in GI Cancer Surgery: A Feasibility Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Computer-Assisted Intervention
Complete online surveys
Device: Vivofit watch
Wear Vivofit watch
Other Names:
  • Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 month
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.
Up to 1 month
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.
Up to 1 month
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.
Up to 1 month
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.
Up to 1 month
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%.
Up to 1 week post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of use of web-based surveys and wristband device, as measured by responses from Satisfaction Tool
Time Frame: Up to 1 month
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
Time Frame: Up to 1 month
Up to 1 month
Feedback on length of surveys and timing of administration, as measured by responses from Satisfaction Tool
Time Frame: Up to 1 month
Up to 1 month
Mean number of missing items within each questionnaire
Time Frame: 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.
Up to 1 month
Percentage of patients who did not enroll in the study-composite outcome of multiple measure listed
Time Frame: 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.
Up to 1 month
Suggestions for items that were not covered but should be added, as measured by responses from Satisfaction Tool
Time Frame: Up to 1 month
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2015

Primary Completion (Actual)

July 31, 2016

Study Completion (Actual)

July 31, 2016

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15051 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2015-01061 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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