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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Gastrointestinal Cancer

Treatments: Behavioral: Daily Questionnaire; Device: Electronic Activity Monitoring (EAM)

Study type: Observational

Funder types: Other

Identifiers

NCT02909062

16-493

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

54 participants in 1 patient group

Electronic Activity Monitoring (EAM)

Description:

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.

Treatment:

Behavioral: Daily Questionnaire

Device: Electronic Activity Monitoring (EAM)