Beyond Performance Status: Electronic Activity Monitoring to Assess Functional Activity of Patients With Gastrointestinal Malignancy During Chemotherapy.

Study Overview
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Brief Summary
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Electronic activity monitoring (EAM) devices are wearable electronic devices that monitor functional activity and provide personal feedback on activity progression. This study aims to determine if EAM can provide an objective, assessment of patient functional activity. The study will also examine the change in functional activity experienced by patients during the first cycle of chemotherapy. Another objective of the study will be to see if baseline functional activity and the change in functional activity that occurs during the first cycle of chemotherapy can be used to predict patient tolerability of subsequent cycles of chemotherapy.

Official Title
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Beyond Performance Status: Electronic Activity Monitoring to Assess Functional Activity of Patients With Gastrointestinal Malignancy During Chemotherapy

Conditions
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Gastrointestinal Cancer

Intervention / Treatment
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* Device: Electronic Activity Monitoring (EAM)
* Behavioral: Daily Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of gastrointestinal malignancy. Age ≥ 18 years Planned to receive systemic chemotherapy, either adjuvant chemotherapy, or neoadjuvant chemotherapy, or any new line of chemotherapy in the setting of advanced disease. Subjects may enroll prior to chemotherapy or during the first cycle of treatment. Exclusion Criteria: Restricted mobility defined as dependence or anytime use of a walker or wheelchair in the past three months. Refusing systemic chemotherapy. Concurrent radiotherapy with chemotherapy Have received at least one cycle of chemotherapy in the current chemotherapy regimen.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Electronic Activity Monitoring (EAM)<br>This is a prospective, observational study. The study aims to examine the role of EAM as an objective, assessment of patient fitness in patients receiving chemotherapy for gastrointestinal malignancy. Physical activity level measured by EAM will be compared with standard measurement tools used by the oncology community to predict chemotherapy tolerability. | Device: Electronic Activity Monitoring (EAM)<br>* All registered patients will receive a wearable EAM device that will measure their physical activity. Patients will wear this device around their wrist for the designated period of assessment. The EAM device has the potential to measure active minutes, number of steps, distance walked and number of floors climbed. For the purpose of this study the EAM data captured will focus on daily step count.<br>Behavioral: Daily Questionnaire<br>* Participants will be asked to complete this self-administered, paper-based questionnaire each day that they are expected to wear the EAM device. The questionnaire was designed specifically for the purpose of this study. It consists of 5 items that ask about the patient's perceived level of physical activity and fatigue in each 24 hour period that they have worn the EAM device. The daily questionnaires will be optional; however each participant will be encouraged to complete them.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EAM Max Step-count On-Chemotherapy - EAM Max Step-count Pre-Chemotherapy | change in physical activity between pre-chemotherapy and on-chemotherapy by counting the steps | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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16-493, Electronic Activity Monitoring (EAM)