Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04772118
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2021-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Cancer Outcomes Through Personalized Care Planning and Symptom Management.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcomes for Primary Aim 1 - 50 intervention participants with a diagnosis for lung, breast or ovarian cancer measuring the prevalence and severity of 18 different symptoms reported from home over 3 months.', 'timeFrame': '10 months', 'description': 'Aim 1 is to compare treatment side effect frequency and intensity and patient treatment adherence between Intervention and Control subjects.\n\nData collection for this Aim includes side effect frequency and intensity and time on treatment. Patients in the intervention arm will complete the Core Assessment prior to enrollment as standard of care. They will be enrolled to use the Carevive PROmpt™ platform to access from home. Patients will be instructed to report symptoms once a week between clinic visits.\n\nOutcomes measures for this Aim are the prevalence and severity of symptoms in each group, adherence to symptom reporting from home in intervention participants, and time on treatment from enrollment to 3 months after enrollment.\n\nPrevalence will be determined by the number of symptom alerts per patient over 3 months/ Severity will be determined by the number of mild, moderate, severe, and very severe over 3 months.'}], 'secondaryOutcomes': [{'measure': 'Outcomes for Secondary Aim 2 - 50 intervention patients will complete the Patient Satisfaction Survey at the 3month timepoint to measure satisfaction with treatment decision and care experience.', 'timeFrame': '10 months', 'description': 'Aim 2 is to describe patient satisfaction with care experience and satisfaction with treatment decision.\n\nPatient satisfaction with care experience and satisfaction with treatment decision will be measured with the Patient Satisfaction Survey (Appendix E). This survey is derived from the Survey of Patient Experiences with Cancer Care Survey (i.e., the Cancer CAHPS) which was developed specifically for cancer patients and is used to evaluate satisfaction with care in the Oncology Care Model (OCM). Surveys will be completed by intervention patients at the three months visit (by paper or electronically) or from home (electronically or by phone administered by the RC) if no visit is planned.'}, {'measure': 'Outcomes for Secondary Aim 3 - Feasibility will be measured by completion of the patient questionnaires and patient symptom reports by the 50 intervention patients. Usability will be measured through provider feedback.', 'timeFrame': '10 months', 'description': 'Aim 3 is to determine feasibility/usability of the electronic treatment planning and symptom assessment for the intervention arm only.\n\nFeasibility will be determined by the number of patients enrolled compared to the number of patients approached, and of those declined the reasons for the decline.\n\nUsability will be determined by the results of the patient satisfaction survey.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Breast Cancer', 'Gynecologic Cancer']}, 'descriptionModule': {'briefSummary': 'This Study is a case control Study conducted with 100 patients with a solid tumor cancer diagnosis (lung, breast, or gynecologic cancer). Records of 50 patients who received treatment plans as standard of care will be abstracted for control data. 50 patients undergoing cancer treatment will receive a treatment plan and report symptoms using Carevive PROmPT™.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants must be 18 years of age or older.\n* Subject participants must have a diagnosis of a breast, lung, or gynecologic cancer.\n* Patients must have completed their navigation visit and received a Treatment Care Plan.\n* Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.\n* Subjects must be starting or receiving treatment.\n* All participants must be able to understand English.\n\nExclusion Criteria:\n\n* Any patient who cannot understand written or spoken English.\n* Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.\n* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).'}, 'identificationModule': {'nctId': 'NCT04772118', 'briefTitle': 'Improving Cancer Outcomes Through Personalized Care Planning and Symptom Management.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carevive Systems, Inc.'}, 'officialTitle': 'Improving Cancer Outcomes Through Personalized Care Planning and Symptom Managment', 'orgStudyIdInfo': {'id': 'G423 Multi TP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Carevive PROmpt™', 'type': 'OTHER', 'description': 'Patient Reported Outcomes Mobile Patient (Carevive PROmpt™), a digital cancer symptom monitoring platform.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carevive Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}