Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-30 @ 8:06 AM
Study NCT ID:
NCT04843657
Status:
UNKNOWN
Last Update Posted:
2021-04-13
First Post:
2021-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precise Care for Cancer Related Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Microbiota'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fatigue', 'timeFrame': '7-8 days', 'description': 'severity of fatigue level; measurement tool: Brief Fatigue Index'}, {'measure': 'Heart Rate Variability (HRV) monitor', 'timeFrame': '7-8 days', 'description': 'Use a digital device to measure the heart rate variability and calculate the HRV data'}], 'secondaryOutcomes': [{'measure': 'Distress Thermometer(DT)', 'timeFrame': '7-8 days', 'description': 'a screening measure to identify and address psychological distress in individuals with cancer. a cutoff score of 3 on the DT to indicate patients with clinically elevated levels of distress.'}, {'measure': 'Leeds Sleep Evaluation Questionnaire(LSEQ）', 'timeFrame': '7-8 days', 'description': 'To assess sleep quality, higher scores mean more disrupt sleep.'}, {'measure': 'International Physical Activity Questionnaire(IPAQ）', 'timeFrame': '7-8 days', 'description': 'Life activity survey'}, {'measure': 'Perceived Stress Scale (PSS）', 'timeFrame': '7-8 days', 'description': 'higher scores mean more stressful condition'}, {'measure': 'ESAS (Edmonton Symptom Assessment Scale)', 'timeFrame': '7-8 days', 'description': 'higher scores mean more severe symptoms condition'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer-related fatigue', 'smart bracelet device', 'symptoms for subjective and objective'], 'conditions': ['Cancer-Related Condition']}, 'descriptionModule': {'briefSummary': 'This project expects to enroll 200 cancer patients and their subjective-objective measurements on fatigue, stress, symptoms, and total steps will be validated so that the information can be used in further care and improvement of life of quality of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients with some cancer treatment side effects.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Age ≧ 20 years old; One group had a cancer diagnosis, one group no cancer diagnosis; Can continuous wearing bracelet for 7 days or more\n\nExclusion Criteria:\n\n\\- Unclear and unable to answer the questionnaire'}, 'identificationModule': {'nctId': 'NCT04843657', 'briefTitle': 'Precise Care for Cancer Related Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Objective Data for Cancer Related Fatigue in Cancer Patients', 'orgStudyIdInfo': {'id': 'cancer related fatigue monitor'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observation for symptom distress', 'type': 'BEHAVIORAL', 'description': 'Observation for symptom distress'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tsai-Wei Huang', 'role': 'CONTACT', 'email': 'tsaiwei@tmu.edu.tw', 'phone': '+88627361661'}], 'overallOfficials': [{'name': 'Tsai-Wei Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}