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Completed

NCT Number: NCT03396510

Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMPROVED intervention

Other

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Alliance for Clinical Trials in Oncology Cancer Control Program (CCP)

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2018
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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