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NCT03396510 Clinical Trial

Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer

Cancer Clinical Trial

Official title:
Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03396510
Other study ID # 17-567
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2018
Est. completion date December 20, 2022

Study information
Verified date December 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 390
Est. completion date December 20, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• IMPROVED intervention
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.

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts General Hospital Alliance for Clinical Trials in Oncology Cancer Control Program (CCP)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Age as a moderator of the effect of IMPROVED on symptom burden The investigators will explore age as a potential moderator on the effect of IMPROVED on symptom burden. 2 years
Other Age as a moderator of the effect of IMPROVED on hospital length of stay The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital length of stay. 2 years
Other Age as a moderator of the effect of IMPROVED on hospital readmissions The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital readmissions. 2 years
Other Sex as a moderator of the effect of IMPROVED on symptom burden The investigators will explore sex as a potential moderator on the effect of IMPROVED on symptom burden. 2 years
Other Sex as a moderator of the effect of IMPROVED on hospital length of stay The investigators will explore sex as a potential moderator on the effect of IMPROVED on hospital length of stay. 2 years
Other Sex as a moderator of the effect of IMPROVED on hospital readmissions The investigators will explore sex as a potential moderator on the effect of IMPROVED on hospital readmissions. 2 years
Other Cancer type as a moderator of the effect of IMPROVED on symptom burden The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on symptom burden. 2 years
Other Cancer type as a moderator of the effect of IMPROVED on hospital readmissions The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on hospital readmissions. 2 years
Other Cancer type as a moderator of the effect of IMPROVED on hospital length of stay The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on hospital length of stay. 2 years
Other Baseline symptom burden as a moderator of the effect of IMPROVED on hospital readmissions The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on hospital readmissions. 2 years
Other Baseline symptom burden as a moderator of the effect of IMPROVED on hospital length of stay The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on hospital length of stay. 2 years
Other Baseline symptom burden as a moderator of the effect of IMPROVED on symptom burden The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on symptom burden. 2 years
Other Hospital length of stay as a moderator of the effect of IMPROVED on symptom burden The investigators will explore hospital length of stay as a potential moderator on the effect of IMPROVED on symptom burden. 2 years
Other Hospital length of stay as a moderator of the effect of IMPROVED on hospital readmissions The investigators will explore hospital length of stay as a potential moderator on the effect of IMPROVED on hospital readmissions. 2 years
Other Symptom burden as a mediator of the effect of IMPROVED on hospital length of stay The investigators will explore whether improvements in symptom burden mediate the benefit of the intervention on hospital length of stay. 2 years
Other Symptom burden as a mediator of the effect of IMPROVED on hospital readmissions The investigators will explore whether improvements in symptom burden mediate the benefit of the intervention on hospital readmissions. 2 years
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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