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History of Changes for Study: NCT03396510
Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer
Latest version (submitted April 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 9, 2018 None (earliest Version on record)
2 February 24, 2018 Recruitment Status, Study Status, Contacts/Locations and Eligibility
3 February 28, 2019 Study Status
4 December 14, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 February 6, 2021 Study Status
6 April 4, 2022 Study Status
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Study NCT03396510
Submitted Date:  January 9, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 17-567
Brief Title: Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer
Official Title: Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2018
Overall Status: Not yet recruiting
Study Start: January 31, 2018
Primary Completion: January 31, 2021 [Anticipated]
Study Completion: January 31, 2024 [Anticipated]
First Submitted: January 3, 2018
First Submitted that
Met QC Criteria:
January 9, 2018
First Posted: January 11, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
January 9, 2018
Last Update Posted: January 11, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Massachusetts General Hospital
Responsible Party: Principal Investigator
Investigator: Ryan Nipp
Official Title: Principal Investigator
Affiliation: Massachusetts General Hospital
Collaborators: Alliance for Clinical Trials in Oncology Cancer Control Program (CCP)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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

Open or close this module Conditions
Conditions: Cancer
Keywords: Cancer Care
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 320 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of days with improved symptoms between study arms
[ Time Frame: 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:
1. Proportion of days with worsened symptoms between study arms
[ Time Frame: 2 years ]

Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms worsened in standard care versus IMPROVED.
2. Change in patients' symptom scores from baseline to discharge
[ Time Frame: 2 years ]

Using ESAS and PHQ symptoms, the investigators will compare the average change in symptom burden for patients in standard care versus IMPROVED.
3. Hospital length of stay (measured continuously as days admitted to the hospital) between study arms
[ Time Frame: 2 years ]

The investigators will compare hospital length of stay (measured continuously as days admitted to the hospital) between study arms.
4. Hospital readmissions within 30 days of prior hospital discharge between study arms
[ Time Frame: 30 days ]

The investigators will compare readmissions within 30 days of prior hospital discharge between study arms.
5. Hospital readmissions within 90 days of prior hospital discharge between study arms
[ Time Frame: 90 days ]

The investigators will compare readmissions within 90 days of prior hospital discharge between study arms.
Other Outcome Measures:
1. Age as a moderator of the effect of IMPROVED on symptom burden
[ Time Frame: 2 years ]

The investigators will explore age as a potential moderator on the effect of IMPROVED on symptom burden.
2. Age as a moderator of the effect of IMPROVED on hospital length of stay
[ Time Frame: 2 years ]

The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital length of stay.
3. Age as a moderator of the effect of IMPROVED on hospital readmissions
[ Time Frame: 2 years ]

The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital readmissions.
4. Sex as a moderator of the effect of IMPROVED on symptom burden
[ Time Frame: 2 years ]

The investigators will explore sex as a potential moderator on the effect of IMPROVED on symptom burden.
5. Sex as a moderator of the effect of IMPROVED on hospital length of stay
[ Time Frame: 2 years ]

The investigators will explore sex as a potential moderator on the effect of IMPROVED on hospital length of stay.
6. Sex as a moderator of the effect of IMPROVED on hospital readmissions
[ Time Frame: 2 years ]

The investigators will explore sex as a potential moderator on the effect of IMPROVED on hospital readmissions.
7. Cancer type as a moderator of the effect of IMPROVED on symptom burden
[ Time Frame: 2 years ]

The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on symptom burden.
8. Cancer type as a moderator of the effect of IMPROVED on hospital readmissions
[ Time Frame: 2 years ]

The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on hospital readmissions.
9. Cancer type as a moderator of the effect of IMPROVED on hospital length of stay
[ Time Frame: 2 years ]

The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on hospital length of stay.
10. Baseline symptom burden as a moderator of the effect of IMPROVED on hospital readmissions
[ Time Frame: 2 years ]

The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on hospital readmissions.
11. Baseline symptom burden as a moderator of the effect of IMPROVED on hospital length of stay
[ Time Frame: 2 years ]

The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on hospital length of stay.
12. Baseline symptom burden as a moderator of the effect of IMPROVED on symptom burden
[ Time Frame: 2 years ]

The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on symptom burden.
13. Hospital length of stay as a moderator of the effect of IMPROVED on symptom burden
[ Time Frame: 2 years ]

The investigators will explore hospital length of stay as a potential moderator on the effect of IMPROVED on symptom burden.
14. Hospital length of stay as a moderator of the effect of IMPROVED on hospital readmissions
[ Time Frame: 2 years ]

The investigators will explore hospital length of stay as a potential moderator on the effect of IMPROVED on hospital readmissions.
15. Symptom burden as a mediator of the effect of IMPROVED on hospital length of stay
[ Time Frame: 2 years ]

The investigators will explore whether improvements in symptom burden mediate the benefit of the intervention on hospital length of stay.
16. Symptom burden as a mediator of the effect of IMPROVED on hospital readmissions
[ Time Frame: 2 years ]

The investigators will explore whether improvements in symptom burden mediate the benefit of the intervention on hospital readmissions.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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 or Mayo Clinic
  • Verbal fluency in English

Exclusion Criteria:

  • Unwilling or unable to participate in the study
  • Admitted electively
  • Participated during a previous admission
Open or close this module Contacts/Locations
Central Contact Person: Ryan Nipp
Telephone: 6177244000
Email: rnipp@mgh.harvard.edu
Study Officials: Ryan Nipp
Principal Investigator
Massachusetts General Hospital
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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