Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-16 @ 12:42 PM
Study NCT ID:
NCT05058495
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2021-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mobile Lymphedema Self-Care Support Program on Self-Care in Women With Breast Cancer-related Lymphedema
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patients were blinded and the person responsible for the data analysis will be masked as to the patient grouping for analysis.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a prospective, randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Breast Cancer Related Lymphedema Self-Care Scale Score', 'timeFrame': 'baseline, 1 month, 3 month', 'description': 'The Breast Related Lymphedema Self-Care Scale is valid and reliable tool. The lowest score is 31, the highest score is 124. Higher scores indicate better self-care.'}, {'measure': 'Change in Quality of Life Measure for Limb Lymphedema-Arm Scale Score', 'timeFrame': 'baseline, 1 month, 3 month', 'description': 'The Quality of Life Measure for Limb Lymphedema-Arm Scale was translated and cross-culturally adapted to Turkish. The highest score of the scale is 80 and the lowest score is 20. A high score indicates poor quality of life.'}, {'measure': 'Change in Lymphedema Symptom Intensity and Distress Survey Score', 'timeFrame': 'baseline, 1 month, 3 month', 'description': 'The Turkish version of Lymphedema Symptom Intensity and Distress Survey is valid and reliable. The highest score of the scale is 30 and the lowest score is zero. A high score means experiencing too many symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in Arm circumferences', 'timeFrame': 'baseline, 1 month, 3 month', 'description': 'Circumferential measurements are taken at the metacarpal joint, wrist, elbow, 10 cm below and 10 cm above the elbow.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['self-care', 'mobile application', 'quality of life', 'patient education', 'symptoms', 'Breast Cancer Related Lymphedema'], 'conditions': ['Breast Cancer Related Lymphedema']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled study is to evaluate the effect of the mobile lymphedema self-care support program on self-care, quality of life and symptoms related to lymphedema in women with breast cancer-related lymphedema.\n\nH1: There is a difference between the Lymphedema Self-Care Scale mean score in women who develop lymphedema due to breast cancer, according to the use of the mobile lymphedema self-care support program.\n\nH2: There is a difference between the Lymphedema Quality of Life Scale average score in women who develop lymphedema due to breast cancer according to the status of using the mobile lymphedema self-care support program.\n\nH4: There is a difference between lymphedema arm circumference measurements according to the use of the mobile lymphedema self-care support program in women who develop lymphedema due to breast cancer.\n\nH5: In women who develop lymphedema due to breast cancer, there is a difference in the situation of experiencing symptoms related to lymphedema according to the use of the mobile lymphedema self-care support program.', 'detailedDescription': 'The content of the mobile program was developed by the researchers. The mobile lymphedema self-care support program content was reviewed by an expert group consisting of doctors, physiotherapists and nurses working with patients with lymphedema. Patients will be contacted via telephone and will be informed about the study, and the experimental and control groups will be selected through the randomization program among the patients who agree to participate in the study and meet the sampling inclusion criteria. Patients were blinded, and blindness will be achieved in the data analysing stage. All measurements will be made to the experimental and control groups at the same time. The standard lymphedema self-care training will be given to the experimental and the control group. And the experimental group will be educated on how to use the mobile program. When the study is completed, the control group will also be allowed to use the mobile program.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed as breast cancer-related lymphedema\n* literate,\n* having a smart phone,\n* completed breast cancer treatment at least six months ago\n* volunteering to participate in the study\n\nExclusion Criteria:\n\n* having morbid obesity\n* having metastazis\n* having dementia\n* having other psychiatric conditions\n* another health problem that could prevent to exercise\n* not using smart phone'}, 'identificationModule': {'nctId': 'NCT05058495', 'briefTitle': 'The Effect of Mobile Lymphedema Self-Care Support Program on Self-Care in Women With Breast Cancer-related Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Investigation of the Effect of Mobile Lymphedema Self-Care Support Program on Self-Care, Quality of Life and Lymphedema-Related Symptoms in Women With Breast Cancer-related Lymphedema: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2020.KB.SAG.069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mobile programme users', 'description': 'Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education.', 'interventionNames': ['Other: Mobile Lymphedema Self-Care Support Program', 'Other: standart lymphedema education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Patients who will receive standart lymphedema education', 'interventionNames': ['Other: standart lymphedema education']}], 'interventions': [{'name': 'Mobile Lymphedema Self-Care Support Program', 'type': 'OTHER', 'otherNames': ['standard lymphedema education'], 'description': 'The Mobile Lymphedema Self-Care Support Program is composed of three section. First section includes the information about lymphedema and lymphedema self care. Second section includes the exercises videos which women can concurrently exercise with application and an alarm to remind to exercise. Last section is a social network form the women could chat and share anything with eachother. Patients will be told how to use the Mobile Lymphedema Self-Care Support Program and a contact number will be provided to ask questions about the program at any time.', 'armGroupLabels': ['mobile programme users']}, {'name': 'standart lymphedema education', 'type': 'OTHER', 'description': 'The control group will receive standard lymphedema education. The standard lymphedema education is an online education composed of information about lymphedema and lymphedema self-care.', 'armGroupLabels': ['control group', 'mobile programme users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35030', 'city': 'Izmir', 'state': 'Bornova', 'country': 'Turkey (Türkiye)', 'facility': 'Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Özgül Karayurt, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Izmir University of Economics'}, {'name': 'Sibel Eyigör, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ege University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zeynep Deveci', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}