Clinical trial NCT02511821: Electronic Monitoring Device of Patient-Reported Outcomes and Function in Improving Patient-Centered Care in Patients With Gastrointestinal Cancer Undergoing Surgery
Official title: Electronic Monitoring of Patient-Reported Outcomes and Function in GI Cancer Surgery: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-07-30
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean time patients are able to tolerate wearing the wristband device, both before and after surgery
timeFrame: Up to 1 month
measure: Mean time to complete the web based questionnaires MDASI and EQ-5D, as well as the Self Geriatric Assessment Measure
timeFrame: Up to 1 month
measure: Median time patients are able to tolerate wearing the wristband device, both before and after surgery
timeFrame: Up to 1 month
measure: Median time to complete the web based questionnaires MDASI and EQ-5D, as well as the Self Geriatric Assessment Measure
timeFrame: Up to 1 month
measure: Percentage of patients who are able to complete the web-based questionnaires MDASI and EQ-5D
timeFrame: Up to 1 month
measure: Percentage of patients who are able to wear the wristband device for at least 1 week post-operatively
timeFrame: Up to 1 week post-operatively
Secondary outcomes:
measure: Ease of use of web-based surveys and wristband device, as measured by responses from Satisfaction Tool
timeFrame: Up to 1 month
measure: Feedback on items in the web-based surveys that are distressing or difficult to comprehend, as measured by responses from Satisfaction Tool
timeFrame: Up to 1 month
measure: Feedback on length of surveys and timing of administration, as measured by responses from Satisfaction Tool
timeFrame: Up to 1 month
measure: Mean number of missing items within each questionnaire
timeFrame: Up to 1 month
measure: Percentage of patients who did not enroll in the study-composite outcome of multiple measure listed
timeFrame: Up to 1 month
measure: Suggestions for items that were not covered but should be added, as measured by responses from Satisfaction Tool
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Virginia Sun
role: PRINCIPAL_INVESTIGATOR
References: