Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-25 @ 4:53 AM
Study NCT ID:
NCT05856292
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2023-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1: Placebo Group 2: Teach-Back'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer pain management', 'timeFrame': 'one month', 'description': 'Quality of cancer pain management. Patient Global Impression Change (PGIC) scale is used to measure the overall quality of life and satisfaction as a conclusion toward the intervention'}], 'secondaryOutcomes': [{'measure': 'Health Literacy', 'timeFrame': 'one month', 'description': 'using Health Literacy Short Form Survey Questionnaire (HLS-EU-SQ10-IDN) to measure the change in health literacy'}, {'measure': 'Pain Level', 'timeFrame': 'weekly up to one month', 'description': 'using Brief Pain Inventory (BPI) to measure the change in pain level'}, {'measure': 'Distress', 'timeFrame': 'weekly up to one month', 'description': 'using distress thermometer to measure change in distress'}, {'measure': 'Belief', 'timeFrame': 'one month', 'description': 'using Barriers Questionnaire (BQ-13) to measure change in belief'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Pain', 'Education'], 'conditions': ['Cancer Pain']}, 'descriptionModule': {'briefSummary': 'This randomized prospective quantitative pilot study compared teach-back method to standardized educational method in patient and caregiver to improve cancer pain management', 'detailedDescription': "Even though there are comprehensive guidelines for cancer pain management, pain control among cancer patients and survivors is often suboptimal due to undertreatment. According to recent studies, the addition of educational interventions could improve pain relief in cancer patients. Both patients and family caregivers play an important role in delivering cancer pain self-management, especially at home. Providing knowledge for cancer pain management with optimal intervention could improve patient and caregiver outcomes.\n\nThe Teach-back method, where patients and family caregivers are asked to repeat the instruction they've received from their health care professionals, can assess patients' understanding, repeat or modify the educational material if comprehension is not demonstrated. This pilot study compared the addition of the Teach-back method for cancer patients and their caregivers and its relation to cancer pain management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe pain (pain scale 4 and above)\n* ≥18 years old\n* Signed the informed consent\n* Willing to cooperate until the end of studies\n* The patient is fully conscious and able to communicate well\n* Cared by a family caregiver\n* Family caregiver able to fully function as a caregiver\n\nExclusion Criteria:\n\n* Near-death (dying) stage\n* Not willing to cooperate until the end of studies\n* Altered mental status and communication difficulties'}, 'identificationModule': {'nctId': 'NCT05856292', 'briefTitle': 'Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Tarumanagara University'}, 'officialTitle': 'Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study', 'orgStudyIdInfo': {'id': 'TarumanagaraU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teach-Back', 'description': "The intervention group were educated using the standard educational method with the addition of Teach-back enhancement. It consists of 5 steps: Triage, Tools, Take Responsibility, Tell Me, and Try Again. The Triage, Tools, and Try Again focus on effective information delivery, while the Take Responsibility and Tell Me evaluate the patient's ability to receive the information", 'interventionNames': ['Other: Teach Back']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-Teach-Back', 'description': 'No educational intervention, just standard educational methods', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Teach Back', 'type': 'OTHER', 'description': 'Standard cancer pain educational intervention enhanced with teach-back method', 'armGroupLabels': ['Teach-Back']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Standard cancer pain educational intervention without enhancement', 'armGroupLabels': ['Non-Teach-Back']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11420', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Dharmais National Cancer Centre', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tarumanagara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ricky Dosan', 'investigatorAffiliation': 'Tarumanagara University'}}}}