An interventional study of Computer-Assisted Intervention and Vivofit watch in Stage I Adult Liver Cancer, Stage I Colorectal Cancer and Stage IA Gastric Cancer, sponsored by City of Hope Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-01-07.
Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Device feasibility
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 22 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Complete online surveys
Wear Vivofit watch
Also known as: Monitor
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Time frame: Up to 1 week post-operatively
Ease of use of web-based surveys and wristband device, as measured by responses from Satisfaction Tool
Time frame: 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
Feedback on length of surveys and timing of administration, as measured by responses from Satisfaction Tool
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
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.
Time frame: 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
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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City of Hope Medical Center