Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT04269967
Status:
UNKNOWN
Last Update Posted:
2022-09-28
First Post:
2020-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Tele-rehabilitation Trial for Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The experience of rehabilitation (i.e., drain care, exercise and massage)', 'timeFrame': '12 weeks from the baseline assessment', 'description': 'We will interview our participants about their experience of going through a rehabilitation process. This is qualitative data.'}, {'measure': 'Shoulder range of motion', 'timeFrame': 'Pre rehabilitation (week 0) and post-rehabilitation (week 12)', 'description': 'Shoulder ranger of motion will be measured in degree.'}, {'measure': 'Arm circumference', 'timeFrame': 'Pre rehabilitation (week 0) and post-rehabilitation (week 12)', 'description': 'Arm circumference will be measured in cm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female']}, 'referencesModule': {'references': [{'pmid': '33522962', 'type': 'DERIVED', 'citation': 'Asano M, Koh GC, Madhukumar P, Teng GYH, Liew PLL, Nagalingam S, Tan MLM, Ng YS, Tan BKT. Study protocol: a pilot quasi-experimental trial of tele-rehabilitation and tele-drain care post-mastectomy. Pilot Feasibility Stud. 2021 Feb 1;7(1):39. doi: 10.1186/s40814-021-00776-5.'}]}, 'descriptionModule': {'briefSummary': 'Breast cancer is the leading cancer affecting women in Singapore. Breast cancer survivors commonly experience declined physical function and quality of life, due to their upper limb morbidity and wound issues post-surgery. Rehabilitation therapy can address the aforementioned issues that the survivors may experience during their recovery. No therapy however, can be effective if patients do not utilize them. Home-based telehealth (e.g., tele-rehabilitation) self-managed by patients and guided by healthcare professionals can potentially improve the service use and recovery. This study aims to understand the lived experience of post-mastectomy tele-rehabilitation and recovery process among female patients who undergo a unilateral mastectomy for breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults female who are undergoing or underwent a unilateral breast surgery (wide excision or simple mastectomy) with lymph nodes removed at two participating sites in Singapore.', 'genderDescription': 'Females identified by their healthcare providers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female 21 years and over\n* Underwent a recent unilateral breast surgery (wide excision or simple mastectomy) with lymph nodes removed\n* Speak and write English or Mandarin;\n* No psychiatric history or chronic psychiatric condition as assessed by referring clinician\n\nExclusion Criteria:\n\n* Having breast reconstruction\n* Having legal blindness or severe visual impairment\n* Having life expectancy of less than three months (12- weeks)\n* Having previous upper limb injury or conditions that limit passive ranges of shoulder flexion (\\<150°), elbow extension/flexion (0/145°)'}, 'identificationModule': {'nctId': 'NCT04269967', 'briefTitle': 'A Pilot Tele-rehabilitation Trial for Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'A Pilot Feasibility Study of a Tele-rehabilitation System Among Women Who Undergo a Unilateral Mastectomy for Breast Cancer', 'orgStudyIdInfo': {'id': '2019/00283'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tele-rehabilitation', 'description': 'Patients who choose tele-rehabilitation', 'interventionNames': ['Other: Receiving routine rehabilitation care via tele-rehabilitation system']}, {'label': 'Usual care', 'description': 'Patients who choose usual (rehabilitation) care'}], 'interventions': [{'name': 'Receiving routine rehabilitation care via tele-rehabilitation system', 'type': 'OTHER', 'description': 'Drain care education, self-massage techniques and exercise (PT and OT)', 'armGroupLabels': ['Tele-rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '117549', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Miho Asano, PhD', 'role': 'CONTACT', 'email': 'epham@nus.edu.sg', 'phone': '(65) 6516 6929'}], 'facility': 'Miho Asano', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Miho Asano', 'role': 'CONTACT', 'email': 'epham@nus.edu.sg', 'phone': '6565166929'}], 'overallOfficials': [{'name': 'Miho Asano', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SSHSPH NUS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Singapore General Hospital', 'class': 'OTHER'}, {'name': 'National Cancer Centre, Singapore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Miho Asano', 'investigatorAffiliation': 'National University of Singapore'}}}}