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Completed

NCT Number: NCT02891993

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

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

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 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

Treatment and study plan

IMPROVED

Other

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

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2016
Registry last updated
Nov 23, 2021

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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