Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-02-06 @ 1:20 AM
Study NCT ID:
NCT00646633
Status:
COMPLETED
Last Update Posted:
2016-07-07
First Post:
2008-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D010353', 'term': 'Patient Education as Topic'}, {'id': 'D008516', 'term': 'Medicine, Chinese Traditional'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D008518', 'term': 'Medicine, East Asian Traditional'}, {'id': 'D008519', 'term': 'Medicine, Traditional'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-05', 'studyFirstSubmitDate': '2008-03-25', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue as measured by the Brief Fatigue Inventory', 'timeFrame': 'prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.'}], 'secondaryOutcomes': [{'measure': 'Health-Related Quality of Life (HRQoL) as measured by the SF36', 'timeFrame': 'prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks.'}, {'measure': 'Pain as measured by an analog scale', 'timeFrame': 'prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks.'}, {'measure': 'Cognitive complaints as measured by the FACT-COG', 'timeFrame': 'prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer', 'Acupuncture'], 'conditions': ['Fatigue']}, 'referencesModule': {'references': [{'pmid': '16484714', 'type': 'BACKGROUND', 'citation': 'Hui KK, Hui EK, Johnston MF. The potential of a person-centered approach in caring for patients with cancer: a perspective from the UCLA center for East-West medicine. Integr Cancer Ther. 2006 Mar;5(1):56-62. doi: 10.1177/1534735405286109.'}, {'pmid': '15851771', 'type': 'BACKGROUND', 'citation': 'Hays RD, Brodsky M, Johnston MF, Spritzer KL, Hui KK. Evaluating the statistical significance of health-related quality-of-life change in individual patients. Eval Health Prof. 2005 Jun;28(2):160-71. doi: 10.1177/0163278705275339.'}, {'pmid': '18648966', 'type': 'BACKGROUND', 'citation': 'Johnston MF, Xiao B, Hui KK. Acupuncture and fatigue: current basis for shared communication between breast cancer survivors and providers. J Cancer Surviv. 2007 Dec;1(4):306-12. doi: 10.1007/s11764-007-0035-9. Epub 2007 Oct 31.'}, {'pmid': '15117996', 'type': 'BACKGROUND', 'citation': 'Vickers AJ, Straus DJ, Fearon B, Cassileth BR. Acupuncture for postchemotherapy fatigue: a phase II study. J Clin Oncol. 2004 May 1;22(9):1731-5. doi: 10.1200/JCO.2004.04.102.'}, {'pmid': '21703001', 'type': 'DERIVED', 'citation': 'Johnston MF, Hays RD, Subramanian SK, Elashoff RM, Axe EK, Li JJ, Kim I, Vargas RB, Lee J, Yang L, Hui KK. Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study. BMC Complement Altern Med. 2011 Jun 25;11:49. doi: 10.1186/1472-6882-11-49.'}]}, 'descriptionModule': {'briefSummary': 'Based on the investigators clinical experience in patients with chronic disease (Hui, Hui, and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui 2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a pilot study that investigates if acupuncture combined with patient education will relieve fatigue in patients who have completed primary treatment for breast cancer.', 'detailedDescription': 'Patients will be randomly assigned to one of the two groups. Our hypothesis is that patients in the acupuncture/education group will experience greater relief of fatigue than those in the standard care group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is between 18 and 65 years of age\n2. Patient has a rounded Brief Fatigue Inventory score of 4 or greater\n3. Patient is in a stable clinical condition\n\nExclusion Criteria:\n\n1. Severe anemia (hemoglobin level less than 9 g/dL, hematocrit level less than 30, decline in hemoglobin of 2 g/dL in the previous month, or active treatment for anemia)\n2. Karnofsky Performance Status below 70\n3. Acupuncture treatment in the previous 6 months\n4. Fatigue before cancer diagnosis\n5. Patient is mentally incapacitated or unfit to provide informed consent or participate in an interview\n6. Patient has the potential for serious bleeding due to inherited diseases such as hemophilia\n7. Patient is taking medications that are either fatigue-inducing or have sedating properties\n8. Patient is unavailable by telephone'}, 'identificationModule': {'nctId': 'NCT00646633', 'briefTitle': 'Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '06-08-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acupuncture & educ', 'description': 'Patients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education.', 'interventionNames': ['Procedure: Acupuncture and patient education']}, {'type': 'NO_INTERVENTION', 'label': '2. Standard care', 'description': 'Patients in the control arm will continue to receive standard care from their physician.'}], 'interventions': [{'name': 'Acupuncture and patient education', 'type': 'PROCEDURE', 'otherNames': ['Traditional Chinese Medicine, Integrative East-West Medicine'], 'description': 'Acupuncture involves the insertion of extremely thin needles, much thinner than those used for drawing blood, into very specific acupuncture points. Patients will receive a total of 8 acupuncture treatments, each lasting 50 minutes. Patient education will be delivered to individuals over the course of approximately 50 minutes for each of the four sessions; topics will include acupressure, nutrition, exercise, stress management, and lifestyle advice.', 'armGroupLabels': ['Acupuncture & educ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Center for East-West Medicine', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}], 'overallOfficials': [{'name': 'Ka-Kit Hui, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA Center for East-West Medicine, 1033 Gayley Ave, Suite 111, Los Angeles, CA 90024'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Susan G. Komen Breast Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}