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

NCT02511821 | Completed DMC

• 3 other identifiers: 15051NCI-2015-01061P30CA033572
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage I Adult Liver Cancer; Stage I Colorectal Cancer; Stage IA Gastric Cancer; Stage IA Pancreatic Cancer; Stage IB Gastric Cancer; Stage IB Pancreatic Cancer; Stage II Adult Liver Cancer; Stage IIA Colorectal Cancer; Stage IIA Gastric Cancer; Stage IIA Pancreatic Cancer; Stage IIB Colorectal Cancer; Stage IIB Gastric Cancer; Stage IIB Pancreatic Cancer; Stage IIC Colorectal Cancer; Stage III Pancreatic Cancer; Stage IIIA Adult Liver Cancer; Stage IIIA Colorectal Cancer; Stage IIIA Gastric Cancer; Stage IIIB Adult Liver Cancer; Stage IIIB Colorectal Cancer; Stage IIIB Gastric Cancer; Stage IIIC Adult Liver Cancer; Stage IIIC Colorectal Cancer; Stage IIIC Gastric Cancer; Stage IV Gastric Cancer; Stage IVA Colorectal Cancer; Stage IVA Liver Cancer; Stage IVA Pancreatic Cancer; Stage IVB Colorectal Cancer; Stage IVB Liver Cancer; Stage IVB Pancreatic Cancer

Outcome Measures

Primary Outcomes (6)

• Mean time patients are able to tolerate wearing the wristband device, both before and after surgery

  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

  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

  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

  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

  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

  Estimated with 95% confidence interval of half-width no more than 16%.

  Up to 1 week post-operatively

Secondary Outcomes (6)

• 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

• Percentage of patients who did not enroll in the study-composite outcome of multiple measure listed

  Up to 1 month

Study Arms (1)

Supportive Care (Vivofit watch, online surveys)

EXPERIMENTAL

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; Device: Vivofit watch; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Computer-Assisted Intervention OTHER

Complete online surveys

Supportive Care (Vivofit watch, online surveys)

Vivofit watch DEVICE

Wear Vivofit watch

Also known as: Monitor

Supportive Care (Vivofit watch, online surveys)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (Vivofit watch, online surveys)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (Vivofit watch, online surveys)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Colorectal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Liver Neoplasms

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Virginia Sun

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 30, 2015
• Study Start: July 22, 2015
• Primary Completion: July 31, 2016
• Study Completion: July 31, 2016
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

US (1)