Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer
December 21, 2022 updated by: Ryan Nipp, Massachusetts General Hospital
This research study is evaluating a new way to deliver oncology care for patients with cancer
Study Overview
Detailed Description
Patients with cancer may experience a considerable symptom burden, often requiring hospitalizations for symptom management. The study doctors want to know if daily electronic monitoring of the symptoms, such as pain, nausea, constipation, and diarrhea may improve care while participants are hospitalized.
The goal of this study is to evaluate a new way to deliver oncology care where patients' symptoms are systematically monitored during their hospital admission. The investigators are studying whether patients whose clinicians receive their patients' detailed symptom reports each day have improved symptom management compared to those whose clinicians do not receive their patients' detailed symptom reports each day.
The study will use questionnaires to measure the participant symptoms and involves participating in a study for as long as the participants are admitted to the hospital. The information the investigators collect will help them determine if electronic symptom monitoring improves the care of patients with cancer
Study Type
Interventional
Enrollment (Actual)
390
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 or older
- Diagnosed with advanced cancer (defined as receiving treatment with palliative intent as per chemotherapy order entry designation, oncology clinic notes, and/or trial consent forms, or not receiving chemotherapy but followed for incurable disease as per oncology clinic notes)
- Admitted to the oncology service at Massachusetts General Hospital
- Verbal fluency in English
Exclusion Criteria:
- Unwilling or unable to participate in the study
- Admitted electively
- Participated during a previous admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: IMPROVED intervention
Patients randomized to the IMPROVED intervention will self-report their symptoms each day using a tablet computer.
If any patient refuses or is unable to complete the symptom assessment on the computer, the study team will permit them to use paper versions.
At morning rounds each day, the clinical team will view reports detailing their patients' symptom burden.
Patients randomized to IMPROVED will have their symptoms presented to their inpatient oncology team, but the study team will not provide guidance about what actions to take in response to patients' symptoms.
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Patients randomized to IMPROVED will self-report their symptoms each day using a tablet computer.
If any patient refuses or is unable to complete the symptom assessment on the computer, the investigators will permit them to use paper versions.
At morning rounds each day, the clinical team will view reports detailing their patients' symptom burden.
Patients randomized to IMPROVED will have their symptoms presented to their inpatient oncology team, but the investigators will not provide guidance about what actions to take in response to patients' symptoms.
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No Intervention: Usual Care
Usual Care per hospital standard will be administered.
Participants receiving usual care will also self-report their symptoms each day using tablet computers.
However, these patients' clinicians will not receive their symptom reports.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of days with improved symptoms between study arms
Time Frame: 2 years
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Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms improved in standard care versus IMPROVED.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of days with worsened symptoms between study arms
Time Frame: 2 years
|
Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms worsened in standard care versus IMPROVED.
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2 years
|
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Change in patients' symptom scores from baseline to discharge
Time Frame: 2 years
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Using ESAS and PHQ symptoms, the investigators will compare the average change in symptom burden for patients in standard care versus IMPROVED.
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2 years
|
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Hospital length of stay (measured continuously as days admitted to the hospital) between study arms
Time Frame: 2 years
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The investigators will compare hospital length of stay (measured continuously as days admitted to the hospital) between study arms.
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2 years
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Hospital readmissions within 30 days of prior hospital discharge between study arms
Time Frame: 30 days
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The investigators will compare readmissions within 30 days of prior hospital discharge between study arms.
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30 days
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Hospital readmissions within 90 days of prior hospital discharge between study arms
Time Frame: 90 days
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The investigators will compare readmissions within 90 days of prior hospital discharge between study arms.
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90 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Age as a moderator of the effect of IMPROVED on symptom burden
Time Frame: 2 years
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The investigators will explore age as a potential moderator on the effect of IMPROVED on symptom burden.
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2 years
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Age as a moderator of the effect of IMPROVED on hospital length of stay
Time Frame: 2 years
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The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital length of stay.
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2 years
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Age as a moderator of the effect of IMPROVED on hospital readmissions
Time Frame: 2 years
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The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital readmissions.
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2 years
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Sex as a moderator of the effect of IMPROVED on symptom burden
Time Frame: 2 years
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The investigators will explore sex as a potential moderator on the effect of IMPROVED on symptom burden.
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2 years
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Sex as a moderator of the effect of IMPROVED on hospital length of stay
Time Frame: 2 years
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The investigators will explore sex as a potential moderator on the effect of IMPROVED on hospital length of stay.
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2 years
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Sex as a moderator of the effect of IMPROVED on hospital readmissions
Time Frame: 2 years
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The investigators will explore sex as a potential moderator on the effect of IMPROVED on hospital readmissions.
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2 years
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Cancer type as a moderator of the effect of IMPROVED on symptom burden
Time Frame: 2 years
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The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on symptom burden.
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2 years
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Cancer type as a moderator of the effect of IMPROVED on hospital readmissions
Time Frame: 2 years
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The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on hospital readmissions.
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2 years
|
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Cancer type as a moderator of the effect of IMPROVED on hospital length of stay
Time Frame: 2 years
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The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on hospital length of stay.
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2 years
|
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Baseline symptom burden as a moderator of the effect of IMPROVED on hospital readmissions
Time Frame: 2 years
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The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on hospital readmissions.
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2 years
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Baseline symptom burden as a moderator of the effect of IMPROVED on hospital length of stay
Time Frame: 2 years
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The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on hospital length of stay.
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2 years
|
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Baseline symptom burden as a moderator of the effect of IMPROVED on symptom burden
Time Frame: 2 years
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The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on symptom burden.
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2 years
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Hospital length of stay as a moderator of the effect of IMPROVED on symptom burden
Time Frame: 2 years
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The investigators will explore hospital length of stay as a potential moderator on the effect of IMPROVED on symptom burden.
|
2 years
|
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Hospital length of stay as a moderator of the effect of IMPROVED on hospital readmissions
Time Frame: 2 years
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The investigators will explore hospital length of stay as a potential moderator on the effect of IMPROVED on hospital readmissions.
|
2 years
|
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Symptom burden as a mediator of the effect of IMPROVED on hospital length of stay
Time Frame: 2 years
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The investigators will explore whether improvements in symptom burden mediate the benefit of the intervention on hospital length of stay.
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2 years
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Symptom burden as a mediator of the effect of IMPROVED on hospital readmissions
Time Frame: 2 years
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The investigators will explore whether improvements in symptom burden mediate the benefit of the intervention on hospital readmissions.
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ryan Nipp, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2018
Primary Completion (Actual)
January 31, 2022
Study Completion (Actual)
December 20, 2022
Study Registration Dates
First Submitted
January 3, 2018
First Submitted That Met QC Criteria
January 9, 2018
First Posted (Actual)
January 11, 2018
Study Record Updates
Last Update Posted (Estimate)
December 23, 2022
Last Update Submitted That Met QC Criteria
December 21, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 17-567
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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