Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-26 @ 6:43 PM
Study NCT ID:
NCT06915168
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in decision preparedness', 'timeFrame': 'up to 12 weeks', 'description': 'Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey.'}], 'secondaryOutcomes': [{'measure': 'Change in decision preparedness', 'timeFrame': 'up to 12 weeks', 'description': 'Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey. A secondary analysis will be conducted using linear regression adjusting for the treatment (adjuvant versus \\[vs\\]. metastatic, paclitaxel vs. docetaxel, weekly vs. 3-weekly) and other baseline variables (e.g., age, chemotherapy-induced peripheral neuropathy \\[CIPN\\] severity).'}, {'measure': 'Change in awareness', 'timeFrame': 'up to 12 weeks', 'description': 'Will be assessed using Question #1 on the Awareness, Preparedness, and Confidence Survey.'}, {'measure': 'Change in discussion confidence', 'timeFrame': 'up to 12 weeks', 'description': 'Will be assessed using Question #3 on the Awareness, Preparedness, and Confidence Survey.'}, {'measure': 'Change in decision preparedness', 'timeFrame': 'up to 12 weeks', 'description': 'Will be assessed using Question #4 on the Awareness, Preparedness, and Confidence Survey.'}, {'measure': 'Change in decision empowerment', 'timeFrame': 'up to 12 weeks', 'description': 'Will be assessed using Question #5 on the Awareness, Preparedness, and Confidence Survey.'}, {'measure': 'Discussion satisfaction', 'timeFrame': 'up to 12 weeks', 'description': 'Will be assessed using Question #6 on the Satisfaction and Helpfulness Survey.'}, {'measure': 'Decision satisfaction', 'timeFrame': 'up to 12 weeks', 'description': 'Will be assessed using Question #7 on the Satisfaction and Helpfulness Survey.'}, {'measure': 'Helpfulness', 'timeFrame': 'up to 12 weeks', 'description': 'Will be assessed using Question #8 on the Satisfaction and Helpfulness Survey.'}, {'measure': 'Taxane chemotherapy treatment decision', 'timeFrame': 'up to 12 weeks', 'description': 'Will be assessed using Question #9 on the Satisfaction and Helpfulness Survey.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Carcinoma']}, 'descriptionModule': {'briefSummary': "This clinical trial studies how well a chemotherapy-induced peripheral neuropathy (CIPN) decision aid works in improving chemotherapy decision making among patients with breast cancer. CIPN involves numbness or tingling in the hands or feet and is a debilitating side effect of several commonly used classes of cancer drugs. CIPN symptoms are typically minor at first but can progress with continued treatment to severe symptoms that can affect long-term function, falls risk, and quality of life. Symptoms sometimes resolve after treatment but in patients who experienced CIPN, symptoms are still present 1 year post-treatment in about two-thirds of patients and 3 years post-treatment in approximately half of the patients. Previous studies indicate patients lack awareness of long-term CIPN symptoms. A decision aid that provides information about permanent CIPN, that helps patients understand their treatment priorities, and prepares them for a discussion with their medical oncologist may lead to improvements in treatment decision making, satisfaction with decision making, and ultimately increase patient's achievement of their treatment goals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with breast cancer\n* Currently receiving cycle three of taxane treatment\n* Approval of medical oncologist to enroll patient\n* Experiencing any CIPN based on enrollment screening question, "In the last 7 days, what was the severity of your numbness or tingling in your hands or feet at its worst? None, Mild, Moderate, Severe, Very Severe. Patient is eligible if their answer is anything except "None"\n* Access to a smartphone or similar device that can complete CIPN DecisionAid via Qualtrics while in the waiting room\n\nExclusion Criteria:\n\n* Inability to read or speak English'}, 'identificationModule': {'nctId': 'NCT06915168', 'briefTitle': 'CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan Rogel Cancer Center'}, 'officialTitle': 'CIPN Decision Aid to Improve Neurotoxic Chemotherapy Decision Making', 'orgStudyIdInfo': {'id': 'HUM00261498'}, 'secondaryIdInfos': [{'id': 'NCI-2024-10529', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'HUM00261498', 'type': 'OTHER', 'domain': 'University of Michigan Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (CIPN DecisionAid)', 'description': 'Patients receive the CIPN DecisionAid on study.', 'interventionNames': ['Other: Informational Intervention', 'Other: Survey Administration']}], 'interventions': [{'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Given CIPN DecisionAid', 'armGroupLabels': ['Supportive care (CIPN DecisionAid)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (CIPN DecisionAid)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel L. Hertz', 'role': 'CONTACT', 'email': 'DLHertz@med.umich.edu', 'phone': '734-763-0015'}, {'name': 'Daniel L. Hertz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Daniel Hertz', 'role': 'CONTACT', 'email': 'DLHertz@med.umich.edu', 'phone': '734-763-0015'}], 'overallOfficials': [{'name': 'Daniel L Hertz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Rogel Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan Rogel Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}