Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: IMPROVED intervention

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

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Alliance for Clinical Trials in Oncology Cancer Control Program (CCP)
• Investigators: Principal Investigator: Ryan Nipp, Massachusetts General Hospital

Publications and helpful links

General Publications

• Nipp RD, Horick NK, Qian CL, Knight HP, Kaslow-Zieve ER, Azoba CC, Elyze M, Landay SL, Kay PS, Ryan DP, Jackson VA, Greer JA, El-Jawahri A, Temel JS. Effect of a Symptom Monitoring Intervention for Patients Hospitalized With Advanced Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):571-578. doi: 10.1001/jamaoncol.2021.7643.

Study record dates

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: Cancer Care
• 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