Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-03-10 @ 10:19 PM
Study NCT ID:
NCT06498193
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer-related Fatigue Among Patients Receiving Home-based Palliative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-07', 'studyFirstSubmitDate': '2024-07-07', 'studyFirstSubmitQcDate': '2024-07-07', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing CRF scores at baseline with those after one week,', 'timeFrame': '1 week', 'description': 'The BFI survey was utilized to promptly assess CRF severity and its impact on daily functioning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hospice care; cancer-related fatigue; Eastern Cooperative Oncology Group Scale'], 'conditions': ['to Investigate the Level of Fatigue Among Terminal Cancer Patients Receiving Home-based Hospice Care']}, 'descriptionModule': {'briefSummary': 'Cancer-related fatigue, which significantly impacts the quality of life, is prevalent among patients with terminal cancer. The experiences of fatigue, its associated needs, and the strategies for managing it are closely linked to the individual uniqueness, cultural background, and resource availability of terminal cancer patients.', 'detailedDescription': 'Fatigue is defined as any perceived or actual physical or mental tiredness that adversely affects the quality of life \\[7,8\\]. The multifaceted nature of fatigue means it manifests in various forms, including physical cognitive, and emotional. Fatigue may involve chronic exhaustion and reduced mobility that cannot be relieved by rest \\[9,10\\]. CRF is associated with cancer progression and treatment, presenting it as a painful, persistent, and subjective sensation involving physical, emotional, and cognitive tiredness or exhaustion. CRF disproportionately affects physical activities and impairs executive functions in daily life \\[10,11\\]. Factors contributing to CRF include cancer itself, treatment side effects, psychological factors such as personality traits (e.g., levels of optimism, anxiety, or depression), comorbid physical conditions, iatrogenic comorbidities, and lifestyle factors (e.g., physical activity levels) \\[10-12\\]. From the perspective of individual patients, fatigue frequently coexists with symptom clusters, such as insomnia, low mood or depression, or pain, collectively resulting in reduced daily functioning and diminished quality of life \\[13\\]. Various non-pharmaceutical interventions have demonstrated effectiveness in addressing CRF, including physical activity, mind-body approaches, and psychosocial interventions \\[9,14,15\\]. Therefore, this study aims to investigate the level of fatigue among terminal cancer patients receiving home-based hospice care, hospital-based hospice care, and hospice-shared care. The anticipated results may facilitate the enhancement of CRF management strategies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Terminal cancer patients receiving hospital-based, hospice-shared, or home-based hospice care under the supervision of a teaching hospital in Taipei, Taiwan, were recruited through convenience sampling', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (i) patients aged 20 years and above proficient in Mandarin and/or Taiwanese and willing to participate in the study; (ii) patients deemed ineligible for curative treatments by oncologists or cancer-related specialists; (iii) patients with an Eastern Cooperative Oncology Group Scale (ECOG) score of 2 or above suitable for hospice care; and (iv) patients who signed a letter of intent for hospice care,\n\nExclusion Criteria:\n\n* preference on their National Health Insurance card, or signed a letter of intent for do-not-resuscitate. Patients deemed too frail'}, 'identificationModule': {'nctId': 'NCT06498193', 'briefTitle': 'Cancer-related Fatigue Among Patients Receiving Home-based Palliative Care', 'organization': {'class': 'OTHER', 'fullName': 'National Taipei University of Nursing and Health Sciences'}, 'officialTitle': 'A Comparative Study of Cancer-related Fatigue Among Patients Receiving Home-based Palliative Care and Hospice-shared Care', 'orgStudyIdInfo': {'id': '108A-07'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taipei university of nursing and health science', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Nursing', 'investigatorFullName': 'Pei-Hung Liao', 'investigatorAffiliation': 'National Taipei University of Nursing and Health Sciences'}}}}