Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT06807294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment Rate for the Tai Chi Program', 'timeFrame': '6 months', 'description': 'The intervention is considered feasible if 21 participants are enrolled within the first 6 months of the study period.'}, {'measure': 'Assessment Completion Rate', 'timeFrame': '12 weeks', 'description': 'The intervention is considered feasible if 75% of all evaluable participants, 16 out of 21, complete the biobehavioral assessments during the intervention period.'}, {'measure': 'Session Completion Rate', 'timeFrame': '12 weeks', 'description': 'The intervention is considered feasible if 62% of participants in the intervention arm, 9 out of 14, attend at least 80% or 20 of the 24 online sessions.'}, {'measure': 'Acceptability of Intervention Measure (AIM) Score', 'timeFrame': '12 weeks', 'description': 'Assessed by the Acceptability of the Intervention Measure (AIM), a 4-item measure rated on a 5-point Likert scale with answers ranging from "Completely disagree" to "Completely agree." A total scores range is 4 to 20 with a higher score indicating greater acceptability.'}], 'secondaryOutcomes': [{'measure': 'Consent Rate (Arm A)', 'timeFrame': 'Up to 6 months (based on total accrual duration)', 'description': 'Defined as the proportion of participants enrolled out of those eligible for study entry.'}, {'measure': 'Consent Rate (Arm B)', 'timeFrame': 'Up to 6 months (based on total accrual duration)', 'description': 'Defined as the proportion of participants enrolled out of those eligible for study entry.'}, {'measure': 'Change in the Gait Health Assessment System from Baseline to 12 Weeks (Arm A)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Assessed by the Zeno Walkway device which is a validated system for measuring gait in older adults. Raw data will be processed by the ProtoKinetics Movement Analysis Software to characterize gait.'}, {'measure': 'Change in the Gait Health Assessment System from Baseline to 12 Weeks (Arm B)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Assessed by the Zeno Walkway device which is a validated system for measuring gait in older adults. Raw data will be processed by the ProtoKinetics Movement Analysis Software to characterize gait.'}, {'measure': 'Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm A)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Assessed by the BBS, a 14-item tool to measure participant balance ability. Each task is scored on a scale from 0 to 4 with a total scores range of 0 to 56. A higher score indicates better balance.'}, {'measure': 'Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm B)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Assessed by the BBS, a 14-item tool to measure participant balance ability. Each task is scored on a scale from 0 to 4 with a total scores range of 0 to 56. A higher score indicates better balance.'}, {'measure': 'Change in Fall Rate from Baseline to 12 Weeks (Arm A)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Defined as the number of falls which occur during the intervention period. A fall is an unplanned descent to the floor with or without injury according to the National Database of Nursing Quality Indicators (NDNQI) definition. Falls included are 1) those occurring on a surface where caregivers and clinicians do not expect to find a participant, and 2) falls unassisted or assisted, and 3) falls from rolling off a low bed.'}, {'measure': 'Change in Fall Rate from Baseline to 12 Weeks (Arm B)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Defined as the number of falls which occurred during the intervention period. A fall is an unplanned descent to the floor with or without injury according to the National Database of Nursing Quality Indicators (NDNQI) definition. Falls included are 1) those occurring on a surface where caregivers and clinicians do not expect to find a participant, and 2) falls unassisted or assisted, and 3) falls from rolling off a low bed.'}, {'measure': 'Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm A)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'As defined by the NDNQI definitions for fall-related injuries. Injuries will be recorded by the participant in the supplied home diary and will be summarized descriptively.'}, {'measure': 'Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm B)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'As defined by the NDNQI definitions for fall-related injuries. Injuries will be recorded by the participant in the supplied home diary and will be summarized descriptively.'}, {'measure': 'Change in Timed-Up-And-Go (TUG) Test from Baseline to 12 Weeks (Arm A)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Assessed by the TUG Test. Participants are instructed to stand up from a chair, walk three meters as quickly and safely as possible, turn around, walk back, and sit down. The test is timed in seconds, with a longer time indicating worse performance. Nine seconds is the cutoff for high risk of falls.'}, {'measure': 'Change in TUG Test from Baseline to 12 Weeks (Arm B)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Assessed by the TUG Test. Participants are instructed to stand up from a chair, walk three meters as quickly and safely as possible, turn around, walk back, and sit down. The test is timed in seconds, with a longer time indicating worse performance. Nine seconds is the cutoff for high risk of falls.'}, {'measure': 'Change in Brief Pain Inventory-Short For (BPI-SF) Score from Baseline to 12 Weeks (Arm A)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Assessed by the BPI-SF, 9-item measure of the severity of pain and pain interference in the 24 hours prior to questionnaire administrations. A simple numeric rating scale from 0 to 10 is used for item rating, and a total score is the mean of the item ratings. Higher scores indicate greater pain intensity and greater interference with function.'}, {'measure': 'Change in BPI-SF Score from Baseline to 12 Weeks (Arm B)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Assessed by the BPI-SF, 9-item measure of the severity of pain and pain interference in the 24 hours prior to questionnaire administrations. A simple numeric rating scale from 0 to 10 is used for item rating, and a total score is the mean of the item ratings. Higher scores indicate greater pain intensity and greater interference with function.'}, {'measure': 'Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm A)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Assessed by the Ntx Subscale of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG) questionnaire. The Ntx Subscale is an 11-item measure of symptoms in the 7 days prior to questionnaire administration. Answers are rated on a 5-point Likert scale ranging from 0 "Not at all" to 4 "Very much" with a total scores range of 0 to 44. Higher scores represent higher functioning and fewer or less severe CIPN symptoms.'}, {'measure': 'Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm B)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Assessed by the Ntx Subscale of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG) questionnaire. The Ntx Subscale is an 11-item measure of symptoms in the 7 days prior to questionnaire administration. Answers are rated on a 5-point Likert scale ranging from 0 "Not at all" to 4 "Very much" with a total scores range of 0 to 44. Higher scores represent higher functioning and fewer or less severe CIPN symptoms.'}, {'measure': 'Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm A)', 'timeFrame': 'Baseline and 12 weeks', 'description': "This will be measured using a set of 20 Von Frey monofilaments. With participant's eyes closed, and starting at the smallest size filament, the clinical research coordinator (CRC) will touch the testing site at a 90-degree angle to the site surface until the filament bends for a one second duration. The CRC will continue this with ascending filament size in order until the participant reports feeling a touch sensation at the testing location. The force at which touch is perceived will be recorded as the tactile threshold. Tactile threshold will be assessed at the dorsum of the interphalangeal joint of the right and left big toes. Value will be recorded as the average of three readings."}, {'measure': 'Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm B)', 'timeFrame': 'Baseline and 12 weeks', 'description': "This will be measured using a set of 20 Von Frey monofilaments. With participant's eyes closed, and starting at the smallest size filament, the clinical research coordinator (CRC) will touch the testing site at a 90-degree angle to the site surface until the filament bends for a one second duration. The CRC will continue this with ascending filament size in order until the participant reports feeling a touch sensation at the testing location. The force at which touch is perceived will be recorded as the tactile threshold. Tactile threshold will be assessed at the dorsum of the interphalangeal joint of the right and left big toes. Value will be recorded as the average of three readings."}, {'measure': 'Change in Vibration Threshold Value from Baseline to 12 weeks (Arm A)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'This will be assessed using a handheld biothesiometer and the amplitude of vibration will be gradually increased (1 volt/second) until the sensation of vibration is first perceived by the participant. The average of three perception thresholds at the dorsal interphalangeal joint of the dominant big toe will be recorded as the vibration threshold.'}, {'measure': 'Change in Vibration Threshold Value from Baseline to 12 weeks (Arm B)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'This will be assessed using a handheld biothesiometer and the amplitude of vibration will be gradually increased (1 volt/second) until the sensation of vibration is first perceived by the participant. The average of three perception thresholds at the dorsal interphalangeal joint of the dominant big toe will be recorded as the vibration threshold.'}, {'measure': 'Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm A)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Assessed by the Short FES-I, a 7-item measure of concerns about falls during daily activities. Answers are rated on a 4-point scale ranging from 1 "Not at all concerned" to 4 "Very concerned" with a total scores range of 7 to 28. A higher score represents greater participant concern.'}, {'measure': 'Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm B)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Assessed by the Short FES-I, a 7-item measure of concerns about falls during daily activities. Answers are rated on a 4-point scale ranging from 1 "Not at all concerned" to 4 "Very concerned" with a total scores range of 7 to 28. A higher score represents greater participant concern.'}, {'measure': 'Change in Functional Reach Test from Baseline to 12 Weeks (Arm A)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The FRT test is used to quantify balance ability. A participant is instructed to flex the test arm forward to 90 degrees and to reach forward as far as possible before taking a step. The reach is determined by the total excursion of the third metacarpal from the starting point (with the handheld in a fist) to the point just before balance is lost. The final score is the average of three measurements.'}, {'measure': 'Change in Functional Reach Test from Baseline to 12 Weeks (Arm B)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The FRT test is used to quantify balance ability. A participant is instructed to flex the test arm forward to 90 degrees and to reach forward as far as possible before taking a step. The reach is determined by the total excursion of the third metacarpal from the starting point (with the handheld in a fist) to the point just before balance is lost. The final score is the average of three measurements.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral Neuropathy', 'Chemotherapy Induced Peripheral Neuropathy'], 'conditions': ['Chemotherapy Induced Peripheral Neuropathy (CIPN)', 'Peripheral Neuropathy Due to Chemotherapy', 'Peripheral Neuropathies']}, 'descriptionModule': {'briefSummary': 'This research is being done to determine whether a 12-week virtual Tai Chi training program, designed to improve balance and small nerve fiber function, is feasible and acceptable among cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN).', 'detailedDescription': 'This is a prospective, randomized, waitlist-controlled pilot trial to examine the suitability of the virtual Tai Chi program in cancer survivors with CIPN. Tai Chi is a mind-body practice that involves gentle body movements, meditation, and breathing techniques. It has proven to be effective in enhancing balance control and relieving musculoskeletal pains.\n\nThis study randomly assigns cancer survivors with CIPN with self-perceived balance difficulties to one of two groups: Group A Tai Chi Group versus Group B Waitlist Group. Randomization means a participant is placed into a study group by chance.\n\nThe research study procedures including screening for eligibility, questionnaires, and sensory and functional testing.\n\nParticipation in this study is expected to last for up to 12 weeks.\n\nIt is expected that about 21 people will take part in this research study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Cancer survivors with no evidence of disease (cancer);\n* Completed neurotoxic chemotherapy, i.e., platinum agents, taxanes, vinca alkaloids, and bortezomib, at least three months before enrollment;\n* A CIPN diagnosis based on symptom history, loss of deep tendon reflexes, or presence of symmetrical stocking-glove pain, numbness, or paresthesia;\n* Answers "yes" to the following question: "Do you feel as though your balance is affected from experiencing CIPN?" "Are you afraid of falling as a result of your CIPN?";\n* On a stable regimen (no change in past three months) if taking anti- neuropathy or other pain medications; and\n* ECOG Performance Status Scale score ≤ 2\n* Willing to adhere to all study-related procedures, including randomization to the Tai Chi or waitlist group, two separate in- person visits to DFCI and Osher Center within 2 weeks of enrollment, and separate in-person visits to DFCI and Osher Center at week 12, and no new pain medication allowed throughout the study period.\n\nNote: Participants receiving endocrine therapy or targeted/antibody therapy (examples including trastuzumab, perturzumab, immunotherapy) will be eligible.\n\nExclusion Criteria:\n\n-Patients who have received physical therapy or Tai Chi training, specifically for CIPN, in the past three months.'}, 'identificationModule': {'nctId': 'NCT06807294', 'briefTitle': 'Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)', 'orgStudyIdInfo': {'id': '24-399'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Tai Chi Treatment Group', 'description': '14 randomized participants will complete:\n\n* 2 baseline visit sessions.\n* Virtual Tai Chi session 2x weekly.\n* Independent Tai Chi sessions 3 days a week.\n* 12 week follow up visit.', 'interventionNames': ['Behavioral: Tai Chi Program']}, {'type': 'NO_INTERVENTION', 'label': 'Arm B: Waitlist Control Group', 'description': '7 randomized participants will complete:\n\n* 2 baseline visit sessions\n* Standard CIPN care prescribed by primary care physician/oncologist.\n* 12 week follow up visit\n* Participants will be offered 24 complimentary, virtual, Tai Chi training sessions over 12 weeks after completion of the 12-week follow-up visit.'}], 'interventions': [{'name': 'Tai Chi Program', 'type': 'BEHAVIORAL', 'description': '12-week virtual Tai Chi program with experienced Tai Chi instructor. Sessions will be conducted via the HIPPA-compliant teleconference platform, Zoom.', 'armGroupLabels': ['Arm A: Tai Chi Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Peter Wayne, PhD', 'role': 'CONTACT', 'email': 'pwayne@bwh.harvard.edu', 'phone': '617-732-4965'}, {'name': 'Peter Wayne, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Ting Bao, MD', 'role': 'CONTACT', 'email': 'ting_bao@dfci.harvard.edu', 'phone': '857-215-2844'}, {'name': 'Ting Bao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Ting Bao, MD', 'role': 'CONTACT', 'email': 'ting_bao@dfci.harvard.edu', 'phone': '857-215-2844'}], 'overallOfficials': [{'name': 'Ting Bao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], '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: \\[contact information for Sponsor Investigator or designee\\]. 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': 'Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Ting Bao, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}