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Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer

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ClinicalTrials.gov Identifier: NCT03396510
Recruitment Status : Active, not recruiting
First Posted : January 11, 2018
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
Alliance for Clinical Trials in Oncology Cancer Control Program (CCP)
Information provided by (Responsible Party):
Ryan Nipp, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Cancer Other: IMPROVED intervention Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2024

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.



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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • Verbal fluency in English

Exclusion Criteria:

  • Unwilling or unable to participate in the study
  • Admitted electively
  • Participated during a previous admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396510


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Alliance for Clinical Trials in Oncology Cancer Control Program (CCP)
Investigators
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Principal Investigator: Ryan Nipp Massachusetts General Hospital
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Responsible Party: Ryan Nipp, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03396510    
Other Study ID Numbers: 17-567
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryan Nipp, Massachusetts General Hospital:
Cancer Care