Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: IMPROVED intervention

• Registration Number: NCT03396510
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-11
• Study Start: 2018-02-12
• Primary Completion: 2022-01-31
• Status Verified: 2022-12
• Study Completion: 2022-12-20
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMPROVED intervention	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.

Primary Outcome Measures

Name	Time	Method
Proportion of days with improved symptoms between study arms	2 years	Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms improved in standard care versus IMPROVED.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States