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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891993
Recruitment Status : Active, not recruiting
First Posted : September 8, 2016
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ryan Nipp, Massachusetts General Hospital

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer
Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

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.




Primary Outcome Measures :
  1. Rates of participant completion of >2 symptom reports [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Rates Of Clinicians Noting Their Patients' Symptom Reports [ Time Frame: 2 years ]
    To determine rates of clinicians noting the symptom reports, the investigators will assess the proportion of clinicians who note their patients' symptom reports.

  2. Rates Of Clinicians Developing An Action Plan In Response To Their Patients' Symptom Reports [ Time Frame: 2 years ]
    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.

  3. Rates Of Clinicians Discussing Their Patients' Symptom Reports [ Time Frame: 2 years ]
    To determine rates of clinicians discussing the symptom reports, the investigators will assess the proportion of clinicians who discuss their patients' symptom reports.

  4. Change In Patients' Symptom Scores [ Time Frame: 2 years ]
    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.

  5. Change In Patients' Psychological Distress [ Time Frame: 2 years ]
    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.

  6. Change In Patients' Depression Scores [ Time Frame: 2 years ]
    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.

  7. Change In Patients' Anxiety Scores [ Time Frame: 2 years ]
    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.

  8. Rates Of Moderate/Severe Symptoms [ Time Frame: 2 years ]
    The investigators will compare rates of moderate/severe symptoms (defined as ESAS scores ≥4) for each day of hospital admission between study arms.

  9. Rates Of Depression Symptoms [ Time Frame: 2 years ]
    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.

  10. Rates Of Anxiety Symptoms [ Time Frame: 2 years ]
    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.

  11. Rates Of Moderate/Severe Psychological Symptoms [ Time Frame: 2 years ]
    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.

  12. Rates Of Patient Satisfaction [ Time Frame: 2 years ]
    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.

  13. Hospital Length Of Stay [ Time Frame: 2 years ]
    The investigators will compare hospital length of stay (measured continuously as days admitted to the hospital) between study arms.

  14. 30-Day Readmissions Rates [ Time Frame: 2 years ]
    The investigators will compare 30-day readmissions rates (defined as a hospital readmission within 30 days of prior hospital discharge) between study arms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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

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): NCT02891993


Locations
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United States, Massachusetts
Massachusetts general Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ryan Nipp, MD Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ryan Nipp, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02891993    
Other Study ID Numbers: 16-228
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ryan Nipp, Massachusetts General Hospital:
Cancer Care