NCT02909062

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastrointestinal Cancer

Interventions

Type	Name	Description
DEVICE	Electronic Activity Monitoring (EAM)	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.
BEHAVIORAL	Daily Questionnaire	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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-08-21
• Completion: 2020-08-21
• First posted: 2016-09-21
• Last updated: 2020-08-25

Locations

6 sites across 1 country: United States