Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-29 @ 8:19 AM
Study NCT ID:
NCT04781712
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2021-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Modular mHealth for Tailored Rehabilitation of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-25', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'satisfaction score in app contents', 'timeFrame': '1 to 12month', 'description': 'satisfaction score in app contents, Likert scale (5-point, higher scores mean a better)'}, {'measure': 'Needs score in app contents', 'timeFrame': '1 to 12month', 'description': 'Needs score in app contents, Likert scale (5-point, higher scores mean a better)'}, {'measure': 'DASH (Disabilities of Arm, Shoulder, Hands)', 'timeFrame': '1 month, 2month, 4month, 6month, 9month, 12month', 'description': 'Change from Baseline DASH score at 12 months, higher scores mean a worse (0-100)'}], 'secondaryOutcomes': [{'measure': 'Physical measurement (handgrip strength)', 'timeFrame': '1 to 12month', 'description': 'Handgrip strength (kg)'}, {'measure': 'Physical measurement (of body composition, BMI)', 'timeFrame': '1 to 12month', 'description': 'Body mass index'}, {'measure': 'Physical measurement (of body composition, muscle mass)', 'timeFrame': '1 to 12month', 'description': 'muscle mass'}, {'measure': 'Physical measurement (upper extremity volume)', 'timeFrame': '1 to 12month', 'description': 'differences in arm circumference'}, {'measure': 'Physical activity (IPAQ-SF Questionnaire)', 'timeFrame': '1 to 12month', 'description': 'Total METs within recent 7 days (vigorous, moderate, walking, sitting), higher values mean a better'}, {'measure': 'PRO-CTCAE (patients reported outcomes)', 'timeFrame': '1 to 12month', 'description': 'Symptoms during treatment'}, {'measure': 'Distress thermometer (distress level)', 'timeFrame': '1 to 12month', 'description': 'Distress level during treatment, higher scores mean a worse (0-10)'}, {'measure': 'App use data (personal health record)_Exercise compliance rate', 'timeFrame': '1 to 12month', 'description': 'Exercise time, higher values mean a better'}, {'measure': 'App use data (personal health record)_Physical activity change', 'timeFrame': '1 to 12month', 'description': 'daily step count (number), higher values mean a better physical activity'}, {'measure': 'App use data (personal health record)_interest of contents', 'timeFrame': '1 to 12month', 'description': 'contents view (number), higher values mean a better compliance rate'}, {'measure': 'App use data (personal health record)_sleep', 'timeFrame': '1 to 12month', 'description': 'sleep compliance rate (%), higher values mean a better compliance rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "This study investigated the feasibility of the novel modular mobile health (mHealth) for personalized rehabilitation and explored the participants' satisfaction and app data during treatment of breast cancer.", 'detailedDescription': 'This is prospective, feasible, parallel study in post-operative patients with breast cancer and during treatment. Disability of Arm, Shoulder, Hands (DASH), Physical activity data (IPAQ-SF), Physical measurement such as hand grip strength, body mass index (BMI), muscle mass, and differences in arm circumference, PRO-CTCAE, Distress Thermometer, needs and satisfaction in app, personal health record of app (exercise, daily step count, etc.) Measure will be evaluated on 1-month, 2-month, 4-month, 6-month, 9-month, and 12-month after POD.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral breast cancer at TNM stage 0 \\~ III\n* Patients who will undergo the treatment (chemotherapy, radiation therapy, and hormone therapy) after surgery\n* Patients who had a mobile phone (Android or iOS)\n\nExclusion Criteria:\n\n\\- Patients who have metastases or recurrence to other organs were excluded'}, 'identificationModule': {'nctId': 'NCT04781712', 'acronym': 'MMHTR', 'briefTitle': 'Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Feasibility of a Modular mHealth for Tailored Rehabilitation During the Treatment of Breast Cancer', 'orgStudyIdInfo': {'id': 'SMC-2018-10-062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-management using mHealth', 'description': 'Self-management (physical activity, sleep, exercise, education, etc.) using mHealth', 'interventionNames': ['Behavioral: Modular mHealth for Tailored Rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Exercise using brochure', 'description': 'Only exercise using brochure'}], 'interventions': [{'name': 'Modular mHealth for Tailored Rehabilitation', 'type': 'BEHAVIORAL', 'otherNames': ['mHealth'], 'description': 'an individually tailored self-management through the mHealth app with a smart band worn on the wrist', 'armGroupLabels': ['Self-management using mHealth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'state': 'Gangnam-gu', 'country': 'South Korea', 'facility': 'Samsung Medical Center', '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'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'JiHye Hwang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}