Gastrointestinal CancerNCT02909062
Beyond Performance Status: Electronic Activity Monitoring to Assess Functional Activity of Patients With Gastrointestinal Malignancy During Chemotherapy.
An observational study of Gastrointestinal Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Electronic Activity Monitoring (EAM) and Daily Questionnaire
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2016to 21 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MSK clinic
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York
About this study
Official title: 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.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Electronic Activity Monitoring (EAM), Daily Questionnaire
- Keywords
- Electronic Activity Monitoring (EAM), 16-493
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 QuestionnaireBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electronic Activity Monitoring (EAM); Behavioral: Daily Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
EAM Max Step-count On-Chemotherapy - EAM Max Step-count Pre-Chemotherapy
change in physical activity between pre-chemotherapy and on-chemotherapy by counting the steps
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startMay 2016
- Primary completion21 Aug 2020
- Study completion21 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Shahrokni, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909062
- Sponsor's protocol ID
- 16-493
- Status last verified
- Aug 2020
- First submitted
- 19 Sep 2016
- Last updated
- 25 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Performance Status: Electronic Activity Monitoring to Assess Functional Activity of Patients With Gastrointestinal Malignancy During Chemotherapy
- ClinicalTrials.gov ID
- NCT02909062
- Acronym / sponsor ID
- 16-493
- Conditions
- Gastrointestinal Cancer
- Keywords
- Electronic Activity Monitoring (EAM), 16-493
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronic Activity Monitoring (EAM) | – | Device: Electronic Activity Monitoring (EAM), Behavioral: Daily QuestionnaireThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSK clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Electronic Activity Monitoring (EAM) |
| Daily QuestionnaireParticipants 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. | Behavioural | Electronic Activity Monitoring (EAM) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Shahrokni, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EAM Max Step-count On-Chemotherapy - EAM Max Step-count Pre-Chemotherapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.