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2015-07-22
2016-07-31
2016-07-31
22
NCT02511821
City of Hope Medical Center
City of Hope Medical Center
INTERVENTIONAL
Electronic Monitoring Device of Patient-Reported Outcomes and Function in Improving Patient-Centered Care in Patients With Gastrointestinal Cancer Undergoing Surgery
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-06-26 | N/A | 2021-01-05 |
2015-07-28 | N/A | 2021-01-07 |
2015-07-30 | N/A | 2021-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Device Feasibility
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Supportive Care (Vivofit watch, online surveys) 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 | OTHER: Computer-Assisted Intervention
DEVICE: Vivofit watch
OTHER: Quality-of-Life Assessment
OTHER: Questionnaire Administration
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 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 |
| 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 |
| Suggestions for items that were not covered but should be added, as measured by responses from Satisfaction Tool | Up to 1 month |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
21 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
