An interventional study of IMPROVED intervention in Cancer, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-23.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
This research study is evaluating a new way to deliver oncology care for patients with cancer
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
Exclusion Criteria:
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
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.
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.
Proportion of days with improved symptoms between study arms
Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms improved in standard care versus IMPROVED.
Time frame: 2 years
Proportion of days with worsened symptoms between study arms
Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms worsened in standard care versus IMPROVED.
Time frame: 2 years
Change in patients' symptom scores from baseline to discharge
Using ESAS and PHQ symptoms, the investigators will compare the average change in symptom burden for patients in standard care versus IMPROVED.
Time frame: 2 years
Hospital length of stay (measured continuously as days admitted to the hospital) between study arms
The investigators will compare hospital length of stay (measured continuously as days admitted to the hospital) between study arms.
Time frame: 2 years
Hospital readmissions within 30 days of prior hospital discharge between study arms
The investigators will compare readmissions within 30 days of prior hospital discharge between study arms.
Time frame: 30 days
Hospital readmissions within 90 days of prior hospital discharge between study arms
The investigators will compare readmissions within 90 days of prior hospital discharge between study arms.
Time frame: 90 days
Age as a moderator of the effect of IMPROVED on symptom burden
The investigators will explore age as a potential moderator on the effect of IMPROVED on symptom burden.
Time frame: 2 years
Age as a moderator of the effect of IMPROVED on hospital length of stay
The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital length of stay.
Time frame: 2 years
Age as a moderator of the effect of IMPROVED on hospital readmissions
The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital readmissions.
Time frame: 2 years
Sex as a moderator of the effect of IMPROVED on symptom burden
The investigators will explore sex as a potential moderator on the effect of IMPROVED on symptom burden.
Time frame: 2 years
Sex as a moderator of the effect of IMPROVED on hospital length of stay
The investigators will explore sex as a potential moderator on the effect of IMPROVED on hospital length of stay.
Time frame: 2 years
Sex as a moderator of the effect of IMPROVED on hospital readmissions
The investigators will explore sex as a potential moderator on the effect of IMPROVED on hospital readmissions.
Time frame: 2 years
Cancer type as a moderator of the effect of IMPROVED on symptom burden
The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on symptom burden.
Time frame: 2 years
Cancer type as a moderator of the effect of IMPROVED on hospital readmissions
The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on hospital readmissions.
Time frame: 2 years
Cancer type as a moderator of the effect of IMPROVED on hospital length of stay
The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on hospital length of stay.
Time frame: 2 years
Baseline symptom burden as a moderator of the effect of IMPROVED on hospital readmissions
The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on hospital readmissions.
Time frame: 2 years
Baseline symptom burden as a moderator of the effect of IMPROVED on hospital length of stay
The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on hospital length of stay.
Time frame: 2 years
Baseline symptom burden as a moderator of the effect of IMPROVED on symptom burden
The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on symptom burden.
Time frame: 2 years
Hospital length of stay as a moderator of the effect of IMPROVED on symptom burden
The investigators will explore hospital length of stay as a potential moderator on the effect of IMPROVED on symptom burden.
Time frame: 2 years
Hospital length of stay as a moderator of the effect of IMPROVED on hospital readmissions
The investigators will explore hospital length of stay as a potential moderator on the effect of IMPROVED on hospital readmissions.
Time frame: 2 years
Symptom burden as a mediator of the effect of IMPROVED on hospital length of stay
The investigators will explore whether improvements in symptom burden mediate the benefit of the intervention on hospital length of stay.
Time frame: 2 years
Symptom burden as a mediator of the effect of IMPROVED on hospital readmissions
The investigators will explore whether improvements in symptom burden mediate the benefit of the intervention on hospital readmissions.
Time frame: 2 years
Plan to share: No
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Massachusetts General Hospital