Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-28 @ 10:40 PM
Study NCT ID:
NCT04517032
Status:
UNKNOWN
Last Update Posted:
2020-08-18
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-13', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Catastrophic Expenditure at 6 months', 'timeFrame': '6 months after treatment decision', 'description': 'Catastrophic expenditure (CE) will be defined as out of pocket payments for CRC treatment greater than 40% of patient income (assessed by an in-person questionnaire led by a researcher).'}], 'secondaryOutcomes': [{'measure': 'Catastrophic Expenditure at 6 weeks', 'timeFrame': '6 weeks after treatment decision', 'description': 'Catastrophic expenditure (CE) will be defined as out of pocket payments for CRC treatment greater than 40% of patient income (assessed by an in-person questionnaire led by a researcher).'}, {'measure': 'Catastrophic Expenditure at 3 months', 'timeFrame': '3 months after treatment decision', 'description': 'Catastrophic expenditure (CE) will be defined as out of pocket payments for CRC treatment greater than 40% of patient income (assessed by an in-person questionnaire led by a researcher).'}, {'measure': 'Treatment compliance at 6 weeks', 'timeFrame': '6 weeks after treatment decision', 'description': 'A compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.'}, {'measure': 'Treatment compliance at 3 months', 'timeFrame': '3 months after treatment decision', 'description': 'A compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.'}, {'measure': 'Treatment compliance at 6 months', 'timeFrame': '6 months after treatment decision', 'description': 'A compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.'}, {'measure': 'Identification of the main drivers of treatment cost', 'timeFrame': '6 months after treatment decision', 'description': '5 most expensive items or services during colorectal cancer treatment'}, {'measure': 'Colorectal cancer stage at the time of diagnosis', 'timeFrame': 'At the time of colorectal cancer diagnosis (coincident with timing of patient enrolment in the study)', 'description': 'AJCC (American Joint Committee on Cancer) guidance - 8th edition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Treatment Compliance', 'Health Care Utilization']}, 'descriptionModule': {'briefSummary': 'Observational study to assess barriers for colorectal cancer treatment compliance in India, including quantitative assessment of catastrophic expenditure incidence and qualitative assessment of financial and non-financial barriers.', 'detailedDescription': 'Objective: To identify a vulnerable group of colorectal cancer patients in India who cannot afford or are unable to comply with a treatment plan for colorectal cancer.\n\nAims:\n\n1. To identify the proportion of CRC patients suffering catastrophic expenditure due to out-of-pocket payments for cancer treatment.\n2. To determine the proportion of patients who are unable to comply with the treatment plan for CRC, at 6 weeks, 3 months and 6 months after diagnosis.\n3. To identify barriers and solutions to CRC treatment compliance. Design: A mixed-methods study comprising quantitative pilot data from 3 tertiary cancer centres and qualitative work from interviews with patients and healthcare professionals.\n\nParticipants: Patients diagnosed with primary colorectal cancer.\n\nOutcomes:\n\nPrimary outcome:\n\n• Incidence of catastrophic expenditure due to out-of-pocket payments for cancer care at 3 timepoints: 6 weeks, 3 months and 6 months after CRC diagnosis.\n\nSecondary outcomes:\n\n* Compliance to the initial treatment plan at three timepoints: 6 weeks, 3 months and 6 months after CRC diagnosis.\n* Patients and healthcare professionals perspectives on patient compliance to CRC treatment.\n* Identify the 5 main drivers (items charged to the patient) of CRC treatment cost.\n* Colorectal cancer stage at the time of diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Adults aged 18+ years old. AND\n* Consecutive new patients with a histopathology proven colorectal cancer for whom a CRC treatment plan is made:\n\n * In an multi-disciplinary team meeting (MDT);\n * OR in the outpatient clinic where an MDT is not available (surgery, oncology or radiotherapy outpatient clinic).\n\nAND\n\n• Undergoing treatment in the hospital where the MDT took place\n\nExclusion Criteria\n\n* Patients with no histopathology available\n* Telephone follow-up not possible'}, 'identificationModule': {'nctId': 'NCT04517032', 'acronym': 'CROCODILE', 'briefTitle': 'ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Birmingham'}, 'officialTitle': 'ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment', 'orgStudyIdInfo': {'id': 'CROC-20200503'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aneel Bhangu, PhD', 'role': 'CONTACT', 'email': 'aneel.bhangu@gmail.com', 'phone': '+44 (0) 121 3718121'}, {'name': 'Joana Simoes, Master', 'role': 'CONTACT', 'email': 'simoes.jff@gmail.com', 'phone': '+44 (0) 121 3718121'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'NIHR Research Unit on Global Surgery', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}