Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT07014657
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Digital Combined Decongestive Therapy in Patients With Breast Cancer-related Lymphedema: a Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072656', 'term': 'Breast Cancer Lymphedema'}], 'ancestors': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Limb Volume', 'timeFrame': 'At baseline, at week 4 (end of treatment), and at week 12 (follow-up)', 'description': 'Limb volume was assessed by measuring the circumference of the affected arm at 4-cm intervals from the ulnar styloid to the axillary region using a standard tape measure. These measurements were used to calculate the total limb volume to evaluate changes after the intervention and at follow-up.'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': 'At baseline, at week 4 (end of treatment), and at week 12 (follow-up)', 'description': 'Quality of life was assessed using the Turkish validated and reliable lymphedema-specific questionnaire, Lymph-ICF. The questionnaire consists of 29 items including 7 questions about arm symptoms and 22 questions related to functional impairments in daily activities. It covers five subscales: physical function, mental status, household activities, mobility activities, and social life. Patients rated their complaints on a 0 to 100 mm visual analog scale (VAS), where 0 indicates no complaints and 100 indicates the worst complaints. Higher scores represent worse quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer-related lymphedema', 'Combined decongestive therapy', 'Digital therapy'], 'conditions': ['Breast Cancer-Related Lymphedema']}, 'referencesModule': {'references': [{'pmid': '34535391', 'type': 'BACKGROUND', 'citation': 'Borman P, Yaman A, Yasrebi S, Pinar Inanli A, Arikan Donmez A. Combined Complete Decongestive Therapy Reduces Volume and Improves Quality of Life and Functional Status in Patients With Breast Cancer-Related Lymphedema. Clin Breast Cancer. 2022 Apr;22(3):e270-e277. doi: 10.1016/j.clbc.2021.08.005. Epub 2021 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'This study investigated the short- and long-term effects of digital combined decongestive therapy in breast cancer-related lymphedema. Limb volume and quality of life (Lymph-ICF) were assessed at baseline, post-treatment, and 12-week follow-up.', 'detailedDescription': 'This study evaluated the feasibility and effectiveness of a digital combined decongestive therapy (CDT) program in patients with breast cancer-related lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital CDT program with remote guidance. Compression garments were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymph-ICF questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with breast cancer-related lymphedema (BCRL) within the last 6 to 60 months.\n* Voluntarily agreed to participate in the study.\n\nExclusion Criteria:\n\n* Presence of active infection.\n* History of bilateral breast surgery.\n* Severe breast cancer-related lymphedema.'}, 'identificationModule': {'nctId': 'NCT07014657', 'briefTitle': 'Effect of Digital Combined Decongestive Therapy in Patients With Breast Cancer-related Lymphedema: a Follow-up Study', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Effect of Digital Combined Decongestive Therapy in Patients With Breast Cancer-related Lymphedema: a Follow-up Study', 'orgStudyIdInfo': {'id': 'Lenfödemüst2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Combined Decongestive Therapy Group', 'description': 'Participants received digital combined decongestive therapy including self-bandaging, self-manual lymphatic drainage, decongestive and breathing exercises, supervised remotely through telecommunication technologies for 4 weeks, followed by maintenance therapy with compression stockings.', 'interventionNames': ['Behavioral: Digital Combined Decongestive Therapy']}], 'interventions': [{'name': 'Digital Combined Decongestive Therapy', 'type': 'BEHAVIORAL', 'description': 'Participants received digital combined decongestive therapy, which included an initial face-to-face session where skin care and risk reduction training were provided. Self-bandaging and self-manual lymphatic drainage techniques were demonstrated and practiced under supervision. Additionally, decongestive and breathing exercises were taught to both patients and caregivers. Following this, the intensive treatment phase was conducted remotely using electronic communication technologies over a period of 4 weeks to monitor and guide the therapy. After the intensive phase, participants continued with maintenance therapy, which involved the use of compression stockings. The therapy aimed to reduce limb volume and improve symptoms related to breast cancer-related lymphedema.', 'armGroupLabels': ['Digital Combined Decongestive Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakıf University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Selva Otsay', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}