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| Name | Class |
|---|---|
| Alliance for Clinical Trials in Oncology Cancer Control Program (CCP) | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMPROVED intervention | Experimental | 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. |
|
| Usual Care | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Change in patients' symptom scores from baseline to discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Age as a moderator of the effect of IMPROVED on hospital length of stay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Nipp | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35142814 | Derived | Nipp RD, Horick NK, Qian CL, Knight HP, Kaslow-Zieve ER, Azoba CC, Elyze M, Landay SL, Kay PS, Ryan DP, Jackson VA, Greer JA, El-Jawahri A, Temel JS. Effect of a Symptom Monitoring Intervention for Patients Hospitalized With Advanced Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):571-578. doi: 10.1001/jamaoncol.2021.7643. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Using ESAS and PHQ symptoms, the investigators will compare the average change in symptom burden for patients in standard care versus IMPROVED. |
| 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. | 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. | 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. | 90 days |
The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital length of stay.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 2 years |