Cancer Clinical Trial
Official title:
Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer
NCT number | NCT02891993 |
Other study ID # | 16-228 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | December 14, 2017 |
Verified date | November 2021 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to address the challenge of symptom management for hospitalized patients with cancer.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 14, 2017 |
Est. primary completion date | June 23, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts general Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rates of participant completion of >2 symptom reports | 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. | 2 years | |
Secondary | Rates Of Clinicians Noting Their Patients' Symptom Reports | To determine rates of clinicians noting the symptom reports, the investigators will assess the proportion of clinicians who note their patients' symptom reports. | 2 years | |
Secondary | Rates Of Clinicians Developing An Action Plan In Response To Their Patients' Symptom Reports | 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. | 2 years | |
Secondary | Rates Of Clinicians Discussing Their Patients' Symptom Reports | To determine rates of clinicians discussing the symptom reports, the investigators will assess the proportion of clinicians who discuss their patients' symptom reports. | 2 years | |
Secondary | Change In Patients' Symptom Scores | 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. | 2 years | |
Secondary | Change In Patients' Psychological Distress | 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. | 2 years | |
Secondary | Change In Patients' Depression Scores | 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. | 2 years | |
Secondary | Change In Patients' Anxiety Scores | 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. | 2 years | |
Secondary | Rates Of Moderate/Severe Symptoms | The investigators will compare rates of moderate/severe symptoms (defined as ESAS scores =4) for each day of hospital admission between study arms. | 2 years | |
Secondary | Rates Of Depression Symptoms | 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. | 2 years | |
Secondary | Rates Of Anxiety Symptoms | 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. | 2 years | |
Secondary | Rates Of Moderate/Severe Psychological Symptoms | 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. | 2 years | |
Secondary | Rates Of Patient Satisfaction | 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. | 2 years | |
Secondary | Hospital Length Of Stay | The investigators will compare hospital length of stay (measured continuously as days admitted to the hospital) between study arms. | 2 years | |
Secondary | 30-Day Readmissions Rates | The investigators will compare 30-day readmissions rates (defined as a hospital readmission within 30 days of prior hospital discharge) between study arms. | 2 years |
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