Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer

The purpose of this research study is to address the challenge of symptom management for hospitalized patients with cancer.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: IMPROVED; Other: Usual Care

Detailed Description

Patients with cancer may experience a considerable symptom burden, often requiring hospitalizations for symptom management. This study will pilot test an electronic symptom monitoring intervention, "Improving Management of Patient-Reported Outcomes Via Electronic Data (IMPROVED)," versus usual care in hospitalized patients with cancer.

The goal of this study is test a model where patients' symptoms are monitored during their hospital admission electronically via tablet computers. 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 takes place at Massachusetts General Hospital 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): 150
• 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 or older
• Diagnosed with incurable cancer (defined as receiving treatment with palliative intent as per chemotherapy order entry designation, trial consent forms, or not receiving chemotherapy but followed for incurable disease as per oncology clinic notes)
• Admitted to Lunder 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 IMPROVED will self-report their symptoms each day using a tablet computer.; The clinical team will view reports detailing their patients' symptom burden; Clinicians will be provided with a graphic depiction of their patients' daily symptom trajectory for that admission	Other: IMPROVED; The electronic symptom monitoring intervention, "Improving Management of Patient-Reported Outcomes Via Electronic Data (IMPROVED)," consists of patients self-reporting their symptoms each day using a tablet computer. At morning rounds each day, the clinical team will view reports detailing their patients' symptom burden.
Active Comparator: Usual Care; Patients randomized to Usual Care will self-report their symptoms each day using a tablet computer; Patients will report their symptoms to their clinicians as they usually would; Clinicians will not be provided with a graphic depiction of their patients' daily symptom trajectory for that admission	Other: Usual Care; 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. Patients randomized to usual care will report their symptoms to their clinicians as they usually would, at their own discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of participant completion of >2 symptom reports	To determine rates of participant completion of >2 symptom reports, the investigators will assess the proportion of enrolled participants who complete of >2 symptom reports.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates Of Clinicians Noting Their Patients' Symptom Reports	To determine rates of clinicians noting the symptom reports, the investigators will assess the proportion of clinicians who note their patients' symptom reports.	2 years
Rates Of Clinicians Developing An Action Plan In Response To Their Patients' Symptom Reports	To determine rates of clinicians developing an action plan in response to the symptom reports, the investigators will assess the proportion of clinicians who develop an action plan in response to their patients' symptom reports.	2 years
Rates Of Clinicians Discussing Their Patients' Symptom Reports	To determine rates of clinicians discussing the symptom reports, the investigators will assess the proportion of clinicians who discuss their patients' symptom reports.	2 years
Change In Patients' Symptom Scores	The investigators will compare change in patients' symptom scores from baseline to discharge (using the Edmonton Symptom Assessment System [ESAS] symptom scores measured continuously) between study arms.	2 years
Change In Patients' Psychological Distress	The investigators will compare change in patients' psychological distress from baseline to discharge (using the Patient Health Questionnaire-4 [PHQ-4] measured continuously) between study arms.	2 years
Change In Patients' Depression Scores	The investigators will compare change in patients' depression scores from baseline to discharge (using the depression questions from the Patient Health Questionnaire-4 [PHQ-4] measured continuously) between study arms.	2 years
Change In Patients' Anxiety Scores	The investigators will compare change in patients' anxiety scores from baseline to discharge (using the anxiety questions from the Patient Health Questionnaire-4 [PHQ-4] measured continuously) between study arms.	2 years
Rates Of Moderate/Severe Symptoms	The investigators will compare rates of moderate/severe symptoms (defined as ESAS scores ≥4) for each day of hospital admission between study arms.	2 years
Rates Of Depression Symptoms	The investigators will compare rates of depression symptoms (defined as a score of 3 or greater on the depression subscale of the PHQ-4) for each day of hospital admission between study arms.	2 years
Rates Of Anxiety Symptoms	The investigators will compare rates of anxiety symptoms (defined as a score of 3 or greater on the anxiety subscale of the PHQ-4) for each day of hospital admission between study arms.	2 years
Rates Of Moderate/Severe Psychological Symptoms	The investigators will compare rates of psychological symptoms (defined as a score of 6 or greater on the PHQ-4) for each day of hospital admission between study arms.	2 years
Rates Of Patient Satisfaction	The investigators will compare rates of patient satisfaction (defined as patients reporting 'very satisfied' using the FAMCARE) for each day of hospital admission between study arms.	2 years
Hospital Length Of Stay	The investigators will compare hospital length of stay (measured continuously as days admitted to the hospital) between study arms.	2 years
30-Day Readmissions Rates	The investigators will compare 30-day readmissions rates (defined as a hospital readmission within 30 days of prior hospital discharge) between study arms.	2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Ryan Nipp, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Nipp RD, El-Jawahri A, Ruddy M, Fuh C, Temel B, D'Arpino SM, Cashavelly BJ, Jackson VA, Ryan DP, Hochberg EP, Greer JA, Temel JS. Pilot randomized trial of an electronic symptom monitoring intervention for hospitalized patients with cancer. Ann Oncol. 2019 Feb 1;30(2):274-280. doi: 10.1093/annonc/mdy488.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): June 23, 2017
• Study Completion (Actual): December 14, 2017

Study Registration Dates

• First Submitted: August 27, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Cancer Care
• Other Study ID Numbers: 16-228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No