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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891993
• Other study ID #: 16-228
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 14, 2017

Study information

• Verified date: November 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 14, 2017
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts general Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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