Gastrointestinal CancerNCT04030624
Remote Electronic Patient Monitoring in Gastrointestinal Cancer
A study testing Remote Electronic Patient Monitoring in people with Gastrointestinal Cancer, run by Massachusetts General Hospital.
Trial summary
The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit. 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?
- Remote Electronic Patient Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to 9 Sep 2020
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 or older
- Diagnosed with gastrointestinal cancer
- Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
- Planning to receive outpatient care at the MGH Cancer Center
- Ability to read and respond to questions in English
Who cannot join
- Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
- Enrolled in hospice
- Planning to be discharged to any location other than their home
About this study
The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit.
Read the detailed description
Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.
The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Remote Electronic Patient Monitoring
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Electronic Patient MonitoringDevice
The Remote Patient Monitoring intervention is a remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate). Data are transmitted from sensors to the patient's smart phone.
| Study group | Role | What they receive |
|---|---|---|
| Remote Electronic Patient Monitoring | Experimental | * The Remote Electronic Patient Monitoring intervention will entail monitoring of vital sign data and patient reported assessments to address and manage any concerning issues identified.
* The Remote Patient Monitoring system uses algorithms that can indicate when patient vitals and patient-reported outcomes have changed.
* Automatic patient surveys are sent to the patient with results displayed on the clinician user interface (i.e., dashboard) on a computer located in the clinical area.
* Qualitative interviews with patient participants and their oncology clinicians using a semi-structured interview guide will be conducted. Receives: Device: Remote Electronic Patient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Feasibility of Remote Electronic Patient Monitoring Intervention
The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.
Measured: 4 weeks
Secondary outcomes (11)
Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period
Measured: 4 weeks
Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period
Measured: 4 weeks
Number of concerning issues identified per patient during study period
Measured: 4 weeks
Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period
Measured: 4 weeks
Number of intervention-triggered emails generated to the primary oncology team during study period
Measured: 4 weeks
Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) during study period
Measured: 4 weeks
Acceptability of Remote Electronic Patient Monitoring Intervention
Participant report of perceptions of the usefulness, effectiveness, and relevance of the intervention per acceptability ratings and qualitative interviews with patient participants and their clinicians.
Measured: 4 weeks
Patient-Reported Quality of Life
Change in patient-reported quality of life from baseline to 2 and 4 weeks per the Functional Assessment of Cancer Therapy-General
Measured: 2 weeks and 4 weeks
Patient-Reported Symptoms
Change in patient-reported symptoms from baseline to 2 and 4 weeks per the Edmonton Symptom Assessment System-revised
Measured: 2 weeks and 4 weeks
Patient-Reported Depression and Anxiety Symptoms
Change in patient-reported depression and anxiety symptoms from baseline to 2 and 4 weeks per the Patient Health Questionnaire-4
Measured: 2 weeks and 4 weeks
Health Care Utilization
Number of urgent clinic visits, emergency department visits, and hospital admissions during study period
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study startSep 2020 (estimated)
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Why it stopped: Funding discontinued due to changes in corporate structures
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 Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph A. Greer, Ph.D., Massachusetts General Hospital
- Investigators
- Joseph Greer, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030624
- Sponsor's protocol ID
- 19-329
- Status last verified
- Nov 2020
- First submitted
- 22 Jul 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Electronic Patient Monitoring in Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT04030624
- Acronym / sponsor ID
- 19-329
- Conditions
- Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding discontinued due to changes in corporate structures
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 24 Jul 2019 (actual)
- 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.
The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit.
Detailed description
Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.
The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Electronic Patient Monitoring | Experimental | Device: Remote Electronic Patient Monitoring* The Remote Electronic Patient Monitoring intervention will entail monitoring of vital sign data and patient reported assessments to address and manage any concerning issues identified. * The Remote Patient Monitoring system uses algorithms that can indicate when patient vitals and patient-reported outcomes have changed. * Automatic patient surveys are sent to the patient with results displayed on the clinician user interface (i.e., dashboard) on a computer located in the clinical area. * Qualitative interviews with patient participants and their oncology clinicians using a semi-structured interview guide will be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Diagnosed with gastrointestinal cancer
- Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
- Planning to receive outpatient care at the MGH Cancer Center
- Ability to read and respond to questions in English
Key exclusion criteria (3 listed)
- Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
- Enrolled in hospice
- Planning to be discharged to any location other than their home
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 |
|---|---|---|
| Remote Electronic Patient MonitoringThe Remote Patient Monitoring intervention is a remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate). Data are transmitted from sensors to the patient's smart phone. | Device | Remote Electronic Patient Monitoring |
Primary outcome
The Feasibility of Remote Electronic Patient Monitoring Intervention
Time frame: 4 weeks
The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.
11 secondary outcomes
Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period
Time frame: 4 weeks
Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period
Time frame: 4 weeks
Number of concerning issues identified per patient during study period
Time frame: 4 weeks
Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period
Time frame: 4 weeks
Number of intervention-triggered emails generated to the primary oncology team during study period
Time frame: 4 weeks
Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) during study period
Time frame: 4 weeks
Acceptability of Remote Electronic Patient Monitoring Intervention
Time frame: 4 weeks
Patient-Reported Quality of Life
Time frame: 2 weeks and 4 weeks
Patient-Reported Symptoms
Time frame: 2 weeks and 4 weeks
Patient-Reported Depression and Anxiety Symptoms
Time frame: 2 weeks and 4 weeks
Health Care Utilization
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Gastrointestinal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
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.
Joseph Greer, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Remote Electronic Patient Monitoring in people with Gastrointestinal Cancer, run by Massachusetts General Hospital.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The Feasibility of Remote Electronic Patient Monitoring Intervention (time frame: 4 weeks). 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 13 Nov 2020.