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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02909062

Enrollment

Registered

2016-09-21

Start date

2016-05-31

Completion date

2020-08-21

Last updated

2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Cancer

Keywords

Electronic Activity Monitoring (EAM), 16-493

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.

Interventions

DEVICEElectronic 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.

BEHAVIORALDaily 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026