Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer

Study Overview
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Brief Summary
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This research study is evaluating a new way to deliver oncology care for patients with cancer

Detailed Description
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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

Official Title
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Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer

Conditions
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Cancer

Intervention / Treatment
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* Other: IMPROVED intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMPROVED intervention<br>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. | Other: IMPROVED intervention<br>* 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.<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of days with improved symptoms between study arms | Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms improved in standard care versus IMPROVED. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of days with worsened symptoms between study arms | Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms worsened in standard care versus IMPROVED. | 2 years | 
| Change in patients' symptom scores from baseline to discharge | Using ESAS and PHQ symptoms, the investigators will compare the average change in symptom burden for patients in standard care versus IMPROVED. | 2 years | 
| Hospital length of stay (measured continuously as days admitted to the hospital) between study arms | The investigators will compare hospital length of stay (measured continuously as days admitted to the hospital) between study arms. | 2 years | 
| Hospital readmissions within 30 days of prior hospital discharge between study arms | The investigators will compare readmissions within 30 days of prior hospital discharge between study arms. | 30 days | 
| Hospital readmissions within 90 days of prior hospital discharge between study arms | The investigators will compare readmissions within 90 days of prior hospital discharge between study arms. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Care