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

Completed

• Conditions: Gastrointestinal Cancer
• Interventions: Device: Electronic Activity Monitoring (EAM); Behavioral: Daily Questionnaire

• Registration Number: NCT02909062
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-21
• Status Verified: 2020-08
• Primary Completion: 2020-08-21
• Study Completion: 2020-08-21
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Electronic Activity Monitoring (EAM)	Electronic Activity Monitoring (EAM)	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.
Electronic Activity Monitoring (EAM)	Daily Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
EAM Max Step-count On-Chemotherapy - EAM Max Step-count Pre-Chemotherapy	1 year	change in physical activity between pre-chemotherapy and on-chemotherapy by counting the steps

Trial Locations

Locations (5)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Rockville Centre; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States