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

Stage III Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511821
• Other study ID #: 15051
• Secondary ID: NCI-2015-0106115
• Status: Completed
• Phase: N/A
• Start date: July 22, 2015
• Est. completion date: July 31, 2016

Study information

• Verified date: January 2021
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 31, 2016
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Computer-Assisted Intervention
Complete online surveys

Device:
• Vivofit watch
Wear Vivofit watch

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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