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

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.

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electronic Activity Monitoring (EAM)

Device

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.

Daily Questionnaire

Behavioral

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.

Primary outcomes

EAM Max Step-count On-Chemotherapy - EAM Max Step-count Pre-Chemotherapy

Time frame: 1 year

change in physical activity between pre-chemotherapy and on-chemotherapy by counting the steps

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Sep 21, 2016
Registry last updated: Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed