Electronic Monitoring Device of Patient-Reported Outcomes and Function in Improving Patient-Centered Care in Patients With Gastrointestinal Cancer Undergoing Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Liver Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/8/2018 |
| Start Date: | July 22, 2015 |
| End Date: | May 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
Duarte, California 91010
Principal Investigator: Virginia Sun
Phone: 800-826-4673
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