Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-08 @ 1:08 AM
Study NCT ID:
NCT03824860
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-19', 'size': 389315, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-09T11:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2019-01-29', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants recruited to participate in the study', 'timeFrame': 'From enrollment to end of treatment at 8 weeks.', 'description': 'Feasibility of participant recruitment to the study'}, {'measure': 'Frequency of yoga practice by participants', 'timeFrame': 'From enrollment to end of treatment at 8 weeks.', 'description': 'Feasibility of participant adherence to the yoga intervention'}, {'measure': 'Frequency of outcome assessments completed by participants.', 'timeFrame': 'From enrollment to end of treatment at 8 weeks.', 'description': 'Feasibility of participant adherence to outcome assessments'}], 'secondaryOutcomes': [{'measure': 'Acceptability and Satisfaction with Participation in Yoga Intervention', 'timeFrame': 'At the end of treatment, 8 weeks after enrollment', 'description': "We will use semi-structured interviews to gain information about participants' experience with the yoga program"}, {'measure': 'Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity', 'timeFrame': 'At the time of enrollment and at the end of treatment, 8 weeks after enrollment', 'description': 'Change in 0 - 10 numerical rating scale of worst chemotherapy-induced peripheral neuropathy pain (via 7-day pain diary) from enrollment to end of treatment at 8 weeks. Total scores range from 0 - 10, with higher scores representing worse pain.'}, {'measure': 'Chemotherapy-Induced Peripheral Neuropathy Severity', 'timeFrame': 'From enrollment to end of treatment at 8 weeks.At the time of enrollment and at the end of treatment, 8 weeks after enrollment', 'description': 'Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale-20 score from enrollment to end of treatment at 8 weeks. Total scores range from 0 - 100, with higher scores representing worse chemotherapy-induced peripheral neuropathy severity.'}, {'measure': 'Pain Interference', 'timeFrame': 'At the time of enrollment and at the end of treatment, 8 weeks after enrollment', 'description': 'Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 41.6 - 75.6, with higher scores representing worse pain interference.'}, {'measure': 'Sleep-Related Impairment', 'timeFrame': 'At the time of enrollment and at the end of treatment, 8 weeks after enrollment', 'description': 'Change in Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment 8a score from enrollment to the end of treatment at 8 weeks. Total scores range from 30.0 - 80.1 with higher scores representing worse sleep-related impairment.'}, {'measure': 'Anxiety assessed by the "Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety"', 'timeFrame': 'At the time of enrollment and at the end of treatment, 8 weeks after enrollment', 'description': 'Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 40.3 - 81.6, with higher scores representing worse anxiety.'}, {'measure': 'Depression assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression', 'timeFrame': 'At the time of enrollment and at the end of treatment, 8 weeks after enrollment', 'description': 'Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 41.0 - 79.4, with higher scores representing worse depression.'}, {'measure': 'Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue', 'timeFrame': 'At the time of enrollment and at the end of treatment, 8 weeks after enrollment', 'description': 'Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 33.7 - 75.8, with higher scores representing worse fatigue.'}, {'measure': 'Physical Function', 'timeFrame': 'At the time of enrollment and at the end of treatment, at 8 weeks.', 'description': 'Change in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 22.5 - 57.0, with higher scores representing better physical function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chemotherapy-induced Peripheral Neuropathy', 'Yoga', 'Chronic Pain', 'Neuropathic Pain'], 'conditions': ['Chemotherapy-induced Peripheral Neuropathy', 'Yoga', 'Chronic Pain', 'Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '34524631', 'type': 'DERIVED', 'citation': 'Knoerl R, Giobbie-Hurder A, Berfield J, Berry D, Meyerhardt JA, Wright AA, Ligibel JA. Yoga for chronic chemotherapy-induced peripheral neuropathy pain: a pilot, randomized controlled trial. J Cancer Surviv. 2022 Aug;16(4):882-891. doi: 10.1007/s11764-021-01081-z. Epub 2021 Sep 15.'}, {'pmid': '33772364', 'type': 'DERIVED', 'citation': 'Knoerl R, Phillips CS, Berfield J, Woods H, Acosta M, Tanasijevic A, Ligibel J. Lessons learned from the delivery of virtual integrative oncology interventions in clinical practice and research during the COVID-19 pandemic. Support Care Cancer. 2021 Aug;29(8):4191-4194. doi: 10.1007/s00520-021-06174-0. Epub 2021 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.', 'detailedDescription': "This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy. The investigators will also explore participants' perceptions of acceptability and satisfaction with the yoga intervention. Lastly, the investigators will examine changes in chemotherapy-induced peripheral neuropathy severity, physical function, sleep-related impairment, fatigue, anxiety, depression, and pain following the eight-week yoga intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-≥18 years of age,\n\n* self-report ≥ 4/10 worst chemotherapy-induced peripheral neuropathy pain over the past week,\n* at least three months post neurotoxic chemotherapy completion\n* signed informed consent,\n* willingness to participate in all study activities\n* speak/read English\n\nExclusion Criteria:\n\n* prognosis of less than three months,\n* documented peripheral neuropathy due to other causes (e.g., diabetes),\n* planned receipt of neurotoxic chemotherapy during the study period,\n* practice yoga \\>45 minutes per week over the past six months,\n* diagnosis or documented recent history of significant psychiatric comorbidity (i.e., psychosis, suicidal ideation, or substance abuse)\n* clinician deems that the patient is physically/functionally unable to participate in a yoga program'}, 'identificationModule': {'nctId': 'NCT03824860', 'briefTitle': 'Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study', 'orgStudyIdInfo': {'id': '18-578'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga Program', 'description': 'Eight-weeks, therapist and self-guided yoga', 'interventionNames': ['Behavioral: Yoga']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study.'}], 'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'description': 'Participants will attend at least one group class per week (in-person or Zoom) and practice one self-guided yoga video class at home on their own per week, over eight weeks\n\nParticipants may choose to attend "Flow Yoga" and/or "Chair Flow Yoga" classes. These classes will be videotaped and made available to participants electronically.\n\nClasses consist of:\n\n* guided breathing exercises,\n* upper and lower extremity stretching\n* structured postures and movements to improve balance and strength', 'armGroupLabels': ['Yoga Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Robert Knoerl, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Robert Knoerl, PhD; Study PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research', 'accessCriteria': "Brigham and Women's Hospital - Contact the Partners Innovations team at http://www.partners.org/innovation"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oncology Nursing Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert Knoerl, PhD, RN', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}