Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-02-28 @ 10:23 PM
Study NCT ID:
NCT01577420
Status:
COMPLETED
Last Update Posted:
2012-04-13
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reflexology: An Intervention for Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-12', 'studyFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2012-04-12', 'lastUpdatePostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Related Quality of Life', 'timeFrame': 'Baseline to week 13'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Reflexology', 'Breast Cancer', 'Complementary'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '19918155', 'type': 'BACKGROUND', '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.'}, {'pmid': '21664296', 'type': 'BACKGROUND', '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': '20467309', 'type': 'BACKGROUND', 'citation': 'Wyatt G, Sikorskii A, Rahbar MH, Victorson D, Adams L. Intervention fidelity: aspects of complementary and alternative medicine research. Cancer Nurs. 2010 Sep-Oct;33(5):331-42. doi: 10.1097/NCC.0b013e3181d0b4b7.'}, {'pmid': '19620179', 'type': 'RESULT', 'citation': 'Sikorskii A, Wyatt GK, Siddiqi AE, Tamkus D. Recruitment and early retention of women with advanced breast cancer in a complementary and alternative medicine trial. Evid Based Complement Alternat Med. 2011;2011:734517. doi: 10.1093/ecam/nep051. Epub 2011 Feb 14.'}]}, '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 women undergoing chemotherapy for late stage (III or IV) breast cancer 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); and the outcome indicator of quality of life.', 'detailedDescription': 'The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III and IV) breast cancer within the context of conventional medical care. This longitudinal randomized clinical trial (RCT) will test a three-group design in which participants will continue to receive conventional care. Two groups of the study will involve a single-blinded four-week protocol: Group A will receive reflexology (a specialized foot therapy) from a certified reflexologist; Group B will receive placebo sessions from a research aide. The control group (Group C) will receive conventional medical care alone. The specific aims are: 1) to determine if women who receive either Groups (A or B) of an experimental protocol (reflexology or placebo) report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone (Group C); 2) to determine if women who receive Group A of an experimental protocol (reflexology), report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving Group B (placebo; 3) to determine if women who receive either Group A or B of an experimental protocol (reflexology or placebo), report significant differences on Intermediate Indicators (physical and emotional), at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone; and 4) to determine if the Intermediate Indicators mediate the group effect on the QOL outcomes (total and subscales) at 7 weeks. This has the potential of leading to an enhanced system of care through the integration of conventional and scientifically-based complementary therapies. It also focuses on advanced disease that is currently under investigation in terms of supportive care measures. Finally, this study utilizes an improved design over existing work. It is a RCT with adequate numbers to detect group differences, and could ultimately serve as a model for rigorous investigation of other complementary therapies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Stage III or IV breast cancer, or Stage I or II with Metastasis or Recurrence\n* Able to perform basic ADLs\n* Free of diagnosis of mental illness on chart\n* Able to speak and understand English\n* Access to a telephone\n* Receiving chemotherapy at intake into the study\n* Palliative Prognostic Score of 11 or lower\n* Oriented to time, place, and person as determined by nurse recruiter\n\nExclusion Criteria:\n\n* Receiving investigational new drug chemotherapy\n* Receiving hospice care at intake\n* Living in nursing home or similar facility\n* Bedridden\n* Undergoing bone marrow transplant\n* Regularly using foot massage\n* Regularly using reflexology\n* Regularly using pedicure with foot massage'}, 'identificationModule': {'nctId': 'NCT01577420', 'briefTitle': 'Reflexology: An Intervention for Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'Reflexology: An Intervention for Advanced Breast Cancer', 'orgStudyIdInfo': {'id': '5R01CA104883-05', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA104883-05', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '5R01CA104883-05', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA104883-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Reflexology Sessions: One session per week performed by certified reflexologist for four consecutive weeks.', 'interventionNames': ['Other: Reflexology Sessions']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'Placebo Sessions: One session per week performed by research aide for four consecutive weeks.', 'interventionNames': ['Other: Placebo Sessions']}, {'type': 'NO_INTERVENTION', 'label': 'Group C', 'description': 'Control; no foot sessions'}], 'interventions': [{'name': 'Reflexology Sessions', 'type': 'OTHER', 'description': 'One session per week performed by certified reflexologist for four consecutive weeks.', 'armGroupLabels': ['Group A']}, {'name': 'Placebo Sessions', 'type': 'OTHER', 'description': 'One session per week performed by research aide for four consecutive weeks.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Northwestern', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mt. Clemens', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '48503', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hurley Medical Center', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48532', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'GLCI/McLaren', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '44405', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. Joseph Mercy Oakland Hospital', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "St. Mary's Health Care Center", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Great Lakes Cancer Institute (GLCI) MSU', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sparrow Hospital', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital-Troy Campus', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '48093', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. John Macomb', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '48323', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Josephine Ford Cancer Care, Henry Ford Hospital', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}], 'overallOfficials': [{'name': 'Gwen Wyatt, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gwen Wyatt', 'investigatorAffiliation': 'Michigan State University'}}}}