Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-27 @ 4:09 AM
Study NCT ID:
NCT01980368
Status:
WITHDRAWN
Last Update Posted:
2018-03-12
First Post:
2013-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled-slow accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-08', 'studyFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2013-11-04', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peripheral sensory neuropathy, assessed by Peripheral Neuropathy Question, European Organization for Research and Treatment of Cancer (EORTC)-30, EORTC-Chemotherapy-induced peripheral neuropathy-20, and the modified Total Neuropathy Score', 'timeFrame': 'Baseline up to 2 months', 'description': 'Will be assessed with a simple t-test of mTNS means. Additional analyses of factors assessed will similarly be conducted (and overall analysis of variance when combining outcome variable assessment at the three time points, and models of factor contribution with logistic regression if appropriate).'}], 'secondaryOutcomes': [{'measure': 'Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)', 'timeFrame': 'Baseline up to 2 months'}, {'measure': 'Changes in body mass index assessed by weight and height', 'timeFrame': 'Baseline up to 2 months', 'description': 'Will be measured directly using standardized protocols with medical-quality calibrated balance scales.'}, {'measure': 'Changes in cognitive performance assessed by digit span and letter-number sequencing', 'timeFrame': 'Baseline up to 2 months'}, {'measure': 'Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection)', 'timeFrame': 'Baseline up to 2 months'}, {'measure': 'Changes in fatigue assessed by Fatigue Symptom Inventory', 'timeFrame': 'Baseline up to 2 months'}, {'measure': 'Changes in pain assessed by Medical Outcomes Study-Short Form 36', 'timeFrame': 'Baseline up to 2 months'}, {'measure': 'Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph', 'timeFrame': 'Baseline up to 2 months'}]}, 'conditionsModule': {'conditions': ['Cancer Survivor', 'Peripheral Sensory Neuropathy']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies how well Tai Chi Easy works in treating cancer survivors with peripheral sensory neuropathy. Tai Chi Easy is a simple and repetitive form of exercise that consists of movements with meditation and may improve peripheral neuropathy symptoms among cancer survivors.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Examine effects of Tai Chi Easy (TCEasy) exercise intervention on peripheral sensory neuropathy of cancer survivors who have chemotherapy compared with an educational control (EC) intervention.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I (TAI CHI EASY): Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks. Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks.\n\nGROUP II (EDUCATIONAL CONTROL): Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.\n\nAfter completion of study, patients are followed up at 2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1 month - 5 years following completion of cytotoxic chemotherapy treatment for any cancer, and are experiencing neuropathy\n* Self-report of \\>= 4 on the Peripheral Neuropathy Question\n\nExclusion Criteria:\n\n* Recurrence of cancer or other active cancer\n* Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)\n* Uncontrolled diabetes, untreated hypothyroidism'}, 'identificationModule': {'nctId': 'NCT01980368', 'briefTitle': 'Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pilot Study of Effects of Tai Chi Easy on Cancer Survivors Experiencing Neuropathy', 'orgStudyIdInfo': {'id': '12-007483'}, 'secondaryIdInfos': [{'id': 'NCI-2016-01373', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '12-007483', 'type': 'OTHER', 'domain': 'Mayo Clinic in Arizona'}, {'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (Tai Chi Easy)', 'description': 'Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks. Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks.', 'interventionNames': ['Behavioral: Exercise Intervention', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (educational control)', 'description': 'Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.', 'interventionNames': ['Other: Educational Intervention', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Receive readings and attend book club', 'armGroupLabels': ['Group II (educational control)']}, {'name': 'Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'Receive Tai Chi Easy class, DVD, and exercise manual', 'armGroupLabels': ['Group I (Tai Chi Easy)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (Tai Chi Easy)', 'Group II (educational control)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Donald Northfelt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}