Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-04-19 @ 7:22 PM
Study NCT ID:
NCT02863302
Status:
UNKNOWN
Last Update Posted:
2017-02-15
First Post:
2016-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reflexology: An Intervention for Acute Myeloid Leukemia(AML) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2016-07-10', 'studyFirstSubmitQcDate': '2016-08-07', 'lastUpdatePostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the FACIT-D questionaire.', 'timeFrame': 'Change from baseline in the FACIT-D questionaire at 1,2,3, and 4 weeks from the beginning of chemotherapy treatment.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effect of reflexology treatment on chemotherapy associated diarrhea', 'timeFrame': 'Diarrhea frequency will be recorded daily from the first day of chemotherapy and up to 30 days.', 'description': 'Diarrhea frequency will be recorded daily by the nursing staff and entered into the patients medical chart.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia, Reflexology'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '21664296', 'type': 'RESULT', 'citation': 'Rahbar MH, Wyatt G, Sikorskii A, Victorson D, Ardjomand-Hessabi M. Coordination and management of multisite complementary and alternative medicine (CAM) therapies: experience from a multisite reflexology intervention trial. Contemp Clin Trials. 2011 Sep;32(5):620-9. doi: 10.1016/j.cct.2011.05.015. Epub 2011 Jun 2.'}, {'pmid': '19918155', 'type': 'RESULT', 'citation': 'Sikorskii A, Wyatt G, Victorson D, Faulkner G, Rahbar MH. Methodological issues in trials of complementary and alternative medicine interventions. Nurs Res. 2009 Nov-Dec;58(6):444-51. doi: 10.1097/NNR.0b013e3181bf15fe.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia. within the context of conventional medical care. Quality of life will be assessed via intermediate indicators: 1) physical indicators (greater physical functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and lower depressive symptomology); by a specific questionnaire. 3) chemotherapy side effects associated with the digestive system.', 'detailedDescription': "The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia within the context of conventional medical care. This open study will test a one group design in which participants will continue to receive conventional care. All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment.\n\nThe specific aims are: 1) to evaluate the effect of reflexology treatment on chemotherapy side effects effecting the digestive system. 2) to evaluate the effect of reflexology treatment on Quality of life. The assessment of the treatment will be executed on the FACIT-D VERSION 3.The influences of the treatment will also be evaluated by the nursing staff, in order to describe the patient's mental health and the condition of his intestinal movement.The side effect before during and after the chemotherapy treatment will be compared using the questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of AML\n* chemotherapy treatment\n* signing a consent form.\n\nExclusion Criteria:\n\n• Not willing to sign a consent form.'}, 'identificationModule': {'nctId': 'NCT02863302', 'briefTitle': 'Reflexology: An Intervention for Acute Myeloid Leukemia(AML) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Reflexology Treatment for Newly Diagnosed AML Patients, Can it Reduce GI Tract Side Effects, and Improve and Improve Patients Mood.', 'orgStudyIdInfo': {'id': '0107-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reflexology treatment', 'description': 'All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment until the end of hospitalization.', 'interventionNames': ['Other: Reflexology treatment']}], 'interventions': [{'name': 'Reflexology treatment', 'type': 'OTHER', 'description': 'All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment.', 'armGroupLabels': ['Reflexology treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Neatanel A Horowitz, MD', 'role': 'CONTACT', 'email': 'n_horowitz@rambam.health.gov.il', 'phone': '97247772541'}, {'name': 'Limor Dan', 'role': 'CONTACT', 'email': 'l_dan@rambam.health.gov.il', 'phone': '97247772541'}], 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Netanel A Horowitz, MD', 'role': 'CONTACT', 'email': 'n_horowitz@rambam.health.gov.il', 'phone': '97247772541'}, {'name': 'Limor Dan, Msc', 'role': 'CONTACT', 'email': 'l_dan@rambam.health.gov.il', 'phone': '97247772541'}], 'overallOfficials': [{'name': 'Netanel A Horowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus, Haifa, Israel.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of ambulatory unit , hematology division', 'investigatorFullName': 'Netanel Horowitz MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}