Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-02-24 @ 5:51 AM
Study NCT ID:
NCT02891993
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2016-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-19', 'studyFirstSubmitDate': '2016-08-27', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of participant completion of >2 symptom reports', 'timeFrame': '2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Rates Of Clinicians Noting Their Patients' Symptom Reports", 'timeFrame': '2 years', 'description': "To determine rates of clinicians noting the symptom reports, the investigators will assess the proportion of clinicians who note their patients' symptom reports."}, {'measure': "Rates Of Clinicians Developing An Action Plan In Response To Their Patients' Symptom Reports", 'timeFrame': '2 years', 'description': "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."}, {'measure': "Rates Of Clinicians Discussing Their Patients' Symptom Reports", 'timeFrame': '2 years', 'description': "To determine rates of clinicians discussing the symptom reports, the investigators will assess the proportion of clinicians who discuss their patients' symptom reports."}, {'measure': "Change In Patients' Symptom Scores", 'timeFrame': '2 years', 'description': "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."}, {'measure': "Change In Patients' Psychological Distress", 'timeFrame': '2 years', 'description': "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."}, {'measure': "Change In Patients' Depression Scores", 'timeFrame': '2 years', 'description': "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."}, {'measure': "Change In Patients' Anxiety Scores", 'timeFrame': '2 years', 'description': "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."}, {'measure': 'Rates Of Moderate/Severe Symptoms', 'timeFrame': '2 years', 'description': 'The investigators will compare rates of moderate/severe symptoms (defined as ESAS scores ≥4) for each day of hospital admission between study arms.'}, {'measure': 'Rates Of Depression Symptoms', 'timeFrame': '2 years', 'description': '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.'}, {'measure': 'Rates Of Anxiety Symptoms', 'timeFrame': '2 years', 'description': '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.'}, {'measure': 'Rates Of Moderate/Severe Psychological Symptoms', 'timeFrame': '2 years', 'description': '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.'}, {'measure': 'Rates Of Patient Satisfaction', 'timeFrame': '2 years', 'description': "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."}, {'measure': 'Hospital Length Of Stay', 'timeFrame': '2 years', 'description': 'The investigators will compare hospital length of stay (measured continuously as days admitted to the hospital) between study arms.'}, {'measure': '30-Day Readmissions Rates', 'timeFrame': '2 years', 'description': 'The investigators will compare 30-day readmissions rates (defined as a hospital readmission within 30 days of prior hospital discharge) between study arms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer Care'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '30395144', 'type': 'DERIVED', 'citation': "Nipp RD, El-Jawahri A, Ruddy M, Fuh C, Temel B, D'Arpino SM, Cashavelly BJ, Jackson VA, Ryan DP, Hochberg EP, Greer JA, Temel JS. Pilot randomized trial of an electronic symptom monitoring intervention for hospitalized patients with cancer. Ann Oncol. 2019 Feb 1;30(2):274-280. doi: 10.1093/annonc/mdy488."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to address the challenge of symptom management for hospitalized patients with cancer.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* 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)\n* Admitted to Lunder at Massachusetts General Hospital\n* Verbal fluency in English\n\nExclusion Criteria:\n\n* Unwilling or unable to participate in the study\n* Admitted electively\n* Participated during a previous admission'}, 'identificationModule': {'nctId': 'NCT02891993', 'briefTitle': 'Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer', 'orgStudyIdInfo': {'id': '16-228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMPROVED Intervention', 'description': "* Patients randomized to IMPROVED will self-report their symptoms each day using a tablet computer.\n* The clinical team will view reports detailing their patients' symptom burden\n* Clinicians will be provided with a graphic depiction of their patients' daily symptom trajectory for that admission", 'interventionNames': ['Other: IMPROVED']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': "* Patients randomized to Usual Care will self-report their symptoms each day using a tablet computer\n* Patients will report their symptoms to their clinicians as they usually would\n* Clinicians will not be provided with a graphic depiction of their patients' daily symptom trajectory for that admission", 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'IMPROVED', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['IMPROVED Intervention']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts general Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ryan Nipp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ryan Nipp', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}