Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT04316156
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2020-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Range of motion'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2020-03-18', 'lastUpdatePostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of motion in affected shoulder', 'timeFrame': 'Enrollment, 4 week, 8 week, 12 week', 'description': 'Evaluation of change in range of motion of the affected shoulder from baseline to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Numerical rating scale of affected shoulder', 'timeFrame': 'Enrollment, 4 week, 8 week, 12 week', 'description': 'Evaluation of pain in the affected shoulder using numerical rating scale minimum \\~ maximum value: 0 \\~ 10, higher scores mean worse outcome.'}, {'measure': 'Functional outcome (Quick Disability of Arm, Shoulder, Hand)', 'timeFrame': 'Enrollment, 4 week, 8 week, 12 week', 'description': 'Evaluation of shoulder function using Quick Disability of Arm, Shoulder, Hand (Quick DASH) ranging from 0 (no disability) to 100 (most severe disability).'}, {'measure': 'Quality of life in the patient with breast cancer (1)', 'timeFrame': 'Enrollment, 4 week, 8 week, 12 week', 'description': 'Evaluation of quality of life using Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) The total FACT-B score ranges from 0 to 123, and is calculated by adding the scores from each of these subscales. Lower scores indicate better health.'}, {'measure': 'Quality of life in the patient with breast cancer (2)', 'timeFrame': 'Enrollment, 4 week, 8 week, 12 week', 'description': 'Evaluation of quality of life using EQ-5D-5L. This scale is numbered from -0.066 to 0.904. lower value means the worst quality of life you can imagine.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '36454316', 'type': 'DERIVED', 'citation': 'Park HY, Nam KE, Lim JY, Yeo SM, Lee JI, Hwang JH. Real-Time Interactive Digital Health Care System for Postoperative Breast Cancer Patients: A Randomized Controlled Trial. Telemed J E Health. 2023 Jul;29(7):1057-1067. doi: 10.1089/tmj.2022.0360. Epub 2022 Nov 29.'}, {'pmid': '34412658', 'type': 'DERIVED', 'citation': 'Park HY, Nam KE, Lim JY, Yeo SM, In Lee J, Hwang JH. Real-time interactive digital healthcare system for post-operative breast cancer patients: study protocol for a randomized controlled trial. Trials. 2021 Aug 19;22(1):549. doi: 10.1186/s13063-021-05535-8.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer. This is prospective study. 100 breast cancer patients who underwent axillary lymph node diessection or breast reconstruction following mastectomy will be examined, and those with limited range of motion (ROM) of affected shoulder will be enrolled in the study. Shoulder ROM, Quick-DASH, pain evaluation with NRS, quality of life evaluation with FACT-B and EQ-5D will be evaluated on enrollment, 4-week, 8-week, and 12-weeks after enrollment.', 'detailedDescription': "The limited range of motion (ROM) of the shoulder occur often after receiving breast cancer surgery, which may be due to post-operative pain, stiffness of shoulder girdle muscle, and etc. Due to this limited ROM, the patients may have difficulty with activities of daily life and quality of life may be reduced.\n\nUincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and motion capture technology to track 3D motion of the patients' articulation. Using this technology, the patients can receive feedback of their motion immediately.\n\nThe objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who underwent breast cancer surgery (axillary lymph node dissection or breast reconstruction following mastectomy)\n* Limited active/passive range of motion of the affected shoulder (Flexion \\<160' or Abduction \\<160')\n* post-operative day not exceeding 8 week\n* Patients who agreed informed consent\n\nExclusion Criteria:\n\n* Bilateral breast cancer surgery\n* Patients with shoulder pain and limited ROM before breast cancer surgery\n* Those unable to perform exercise due to general deconditioning\n* Those with communication difficulty"}, 'identificationModule': {'nctId': 'NCT04316156', 'briefTitle': 'Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial, Assessor Blinding, Multi-center Study', 'orgStudyIdInfo': {'id': 'SMC-2019-05-021 (2)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise using Uincare Homeplus', 'description': 'Uincare Homeplus', 'interventionNames': ['Device: Uincare Homeplus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise using brochure', 'description': 'brochure', 'interventionNames': ['Other: Brochure']}], 'interventions': [{'name': 'Uincare Homeplus', 'type': 'DEVICE', 'otherNames': ['digital healthcare'], 'description': 'Interactive digital healthcare system', 'armGroupLabels': ['Exercise using Uincare Homeplus']}, {'name': 'Brochure', 'type': 'OTHER', 'description': 'Brochure', 'armGroupLabels': ['Exercise using brochure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'state': 'Gangnam-gu', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seocho-gu', 'country': 'South Korea', 'facility': "Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'JIHYE HWANG, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Physical & Rehabilitation Medicine Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Republic of Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'JiHye Hwang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}