Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03208816
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2017-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Community-Led Action Research in Oncology: Improving Symptom Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-23', 'studyFirstSubmitDate': '2017-06-22', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment feasibility', 'timeFrame': 'Through study completion , an average of one year', 'description': 'Number patients enrolled in the study divided by number of patients referred to the study'}], 'secondaryOutcomes': [{'measure': 'Intervention feasibility', 'timeFrame': 'Through study completion, an average of one year', 'description': 'Average number of minutes for each telephone sessions'}, {'measure': 'Fidelity to treatment', 'timeFrame': 'Through study completion, an average of one year', 'description': 'Average fidelity score for rated telephone sessions'}, {'measure': 'Acceptability of intervention', 'timeFrame': 'At study completion, approximately one year', 'description': 'Semi-structured interview of patients and nurse interventionists'}, {'measure': 'Healthcare utilization', 'timeFrame': '12 weeks after enrollment', 'description': 'Average number of cancelled appointments, emergency room visits, and toxicity requiring change in treatment plan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'constipation'], 'conditions': ['Chemotherapy-induced Neutropenia', 'Chemotherapy-induced Nausea and Vomiting', 'Anxiety', 'Depression', 'Fatigue', 'Neoplasms']}, 'referencesModule': {'references': [{'pmid': '30755109', 'type': 'DERIVED', 'citation': 'Bejarano S, Freed ME, Zeron D, Medina R, Zuniga-Moya JC, Kennedy L, Bruce ML, Zubkoff L, Bakitas MA, Lyons KD. Feasibility of a Symptom Management Intervention for Honduran Adults Undergoing Chemotherapy. West J Nurs Res. 2019 Oct;41(10):1517-1539. doi: 10.1177/0193945918825374. Epub 2019 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted at La Liga Contra el Cancer in San Pedro Sula, Honduras. The overall objective of this project is to improve symptom management for patients undergoing chemotherapy in Honduras. The first step in this line of research is a "proof of concept" feasibility study in which the investigators will demonstrate their ability to train nurses to administer a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.', 'detailedDescription': 'The investigators will use the team\'s previous experience delivering a standardized, non-pharmacological palliative care intervention by telephone to inform a "proof of concept" feasibility study in Honduras. They will train nurses at La Liga Contra el Cancer in San Pedro Sula to conduct the telephone sessions and monitor their fidelity to treatment as they enroll a minimum They will then evaluate the feasibility, acceptability, and potential effectiveness of the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are over the age of 18 and are beginning a chemotherapy regimen to treat any solid or hematological cancer will be eligible for the study.\n\nExclusion Criteria:\n\n* Patients who do not start planned chemotherapy.'}, 'identificationModule': {'nctId': 'NCT03208816', 'acronym': 'CLARO', 'briefTitle': 'Community-Led Action Research in Oncology: Improving Symptom Management', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Community-Led Action Research in Oncology: Improving Symptom Management', 'orgStudyIdInfo': {'id': 'CPHS30340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'single arm', 'description': 'symptom management program for chemotherapy patients', 'interventionNames': ['Behavioral: symptom management program for chemotherapy patients']}], 'interventions': [{'name': 'symptom management program for chemotherapy patients', 'type': 'BEHAVIORAL', 'description': 'Nurses will call study participants two times a week, to proactively assess and manage symptoms they might be experiencing during chemotherapy.', 'armGroupLabels': ['single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'San Pedro Sula', 'country': 'Honduras', 'facility': 'La Liga Contra el Cancer', 'geoPoint': {'lat': 15.50585, 'lon': -88.02588}}], 'overallOfficials': [{'name': 'Kathleen D Lyons, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Kathleen Lyons', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}