Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT05701735
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2022-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Decision Aid for Chemotherapy in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Given the nature of the intervention, true blinding could not be done on the participant, who is also the assessor. Blinding is necessary to control for participant expectation bias and participant performance bias. The provider (gynecologic oncologist) of the standard of care (standard consultation) is blinded to the subsequent assignment to either arm.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1: Embedded mixed-methods design Phase 2: Experimental, block-randomized two-arm trial design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2022-12-27', 'studyFirstSubmitQcDate': '2023-01-17', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decisional conflict', 'timeFrame': 'Prior to the second consultation visit (for treatment decision and implementation planning), usually within one week', 'description': 'Decisional Conflict Scale (DCS) scores of ≥25 will indicate significant decisional conflict. The proportion of participants having pretest (baseline) and posttest decisional conflict scores of ≥25 for each group will be reported.'}], 'secondaryOutcomes': [{'measure': 'Utility in preparation for decision-making', 'timeFrame': 'After use of the patient decision aid and prior to the second consultation visit (for treatment decision and implementation planning), usually within one week', 'description': 'For the experimental group, the overall utility of the decision will be measured using the Preparation for Decision-Making Scale (PDMS). This will be reported as the averaged individual user mean scores using the PDMS and the confidence interval.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient decision aid', 'Cervical cancer', 'Chemotherapy', 'Radiotherapy', 'Elderly', 'Renal failure', 'Decisional conflict'], 'conditions': ['Locally Advanced Cervical Carcinoma']}, 'referencesModule': {'references': [{'pmid': '37677124', 'type': 'RESULT', 'citation': 'Bacorro W, Baldivia K, Mariano J, Dancel E, Antonio L, Gonzalez G, Ortin TS, Canlas R. Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer: Development, Alpha Testing, and Peer Validation. JCO Glob Oncol. 2023 Sep;9:e2300096. doi: 10.1200/GO.23.00096.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate the utility and effectiveness of a decision aid in cisplatin-intolerant patients with locally advanced cervical cancer.\n\nThe main questions it aims to answer are:\n\n1. What is the effectiveness of the decision aid in reducing decisional conflict?\n2. What is the utility of the decision aid in preparing for decision-making?\n\nParticipants will be asked to accomplish the Decisional Conflict Scale before and after using the decision aid.\n\nResearchers will compare patients given routine care and the decision aid with patients given routine care to see if the decision aid reduces decisional conflict.', 'detailedDescription': 'In locally advanced cervical cancer (LACC), adding chemotherapy (ChT) to radiotherapy (RT) improves survival at the cost of increased toxicity. Among patients with cisplatin contraindications, compliance to RT may be compromised. Shared decision-making (SDM) allows for more patient engagement in the decision-making process and decision implementation planning. In cancer-related decision-making, patient decision aids (PtDA) facilitate the SDM process and have increased patient knowledge and satisfaction and decreased decisional conflict and attitudinal barriers improved patient satisfaction and treatment compliance.\n\nThe CECIL study is a two-phase study to develop, validate and test the effectiveness of a PtDA for cisplatin-intolerant LACC patients faced with the decision of adding ChT to RT. Phase 1 is a mixed-methods study to develop a PtDA prototype and determine its content validity and user acceptability. Phase 2 is a block-randomized clinical trial to determine its effectiveness in reducing decisional conflict and its utility in preparing for decision-making. Adult women with biopsy-proven untreated LACC with cisplatin contraindications will be included in this trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Squamous, adeno- or adenosquamous histology\n* International Federation of Gynaecology and Obstetrics (FIGO) Stage I-B3, II-A2, II-B to IV-A\n* Contraindication to ChT, including but not limited to hydronephrosis, renal or cardiac dysfunction, frailty, or refusal\n* Grade 6 level English literacy\n* Informed consent\n\nExclusion Criteria:\n\n* Other histologies\n* Metastatic disease\n* Other active cancers\n* Prior cancer EXCEPT for a cancer treated curatively, in remission for ≥5 years, with low recurrence risk; adequately treated lentigo maligna or non-melanoma skin cancer without evidence of disease; or adequately treated carcinoma-in-situ without evidence of disease\n* Prior pelvic radiotherapy, brachytherapy, or chemotherapy\n* Pregnancy\n* Cognitive impairment or psychological disturbance limiting study compliance'}, 'identificationModule': {'nctId': 'NCT05701735', 'acronym': 'CECIL', 'briefTitle': 'Decision Aid for Chemotherapy in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Santo Tomas Hospital, Philippines'}, 'officialTitle': 'Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer (CECIL): Development, Validation and Clinical Testing', 'orgStudyIdInfo': {'id': 'USTH-BCI-RO-2022-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine care', 'description': 'Routine in-house workflow for initial and follow-up consultation, disclosure of diagnosis, and apprisal and counseling regarding treatment options'}, {'type': 'EXPERIMENTAL', 'label': 'Patient decision aid', 'description': 'Routine in-house workflow for initial and follow-up consultation, disclosure of diagnosis, and apprisal and counseling regarding treatment options plus provision of a decision aid after the initial consultation', 'interventionNames': ['Behavioral: CECIL Patient Decision Aid']}], 'interventions': [{'name': 'CECIL Patient Decision Aid', 'type': 'BEHAVIORAL', 'otherNames': ['Decision Support Intervention'], 'description': 'The CECIL patient decision aid explicitly identifies the disease, the index decision, and the treatment options, describes the positive and negative features and consequences of each option, and guides the patient in examining personal values and preferences, to arrive at a quality and realistic decision.\n\nThe decision aid will be developed and validated according to the guidelines and standards published by the International Patient Decision Aids Standards (IPDAS) Collaboration.', 'armGroupLabels': ['Patient decision aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1016', 'city': 'Manila', 'state': 'National Capital Region', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Warren Bacorro, MD', 'role': 'CONTACT', 'email': 'warren.bacorro.gs@ust.edu.ph', 'phone': '09171665927'}, {'name': 'Genalin Amparo, MD', 'role': 'CONTACT', 'email': 'gingfabul@yahoo.com'}, {'name': 'Genalin Amparo, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aris Luke Dungo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Our Lady of Lourdes Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1000', 'city': 'Manila', 'state': 'NCR', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Warren Bacorro, MD', 'role': 'CONTACT', 'email': 'warren.bacorro.gs@ust.edu.ph'}, {'name': 'Aida Bautista, MD', 'role': 'CONTACT', 'email': 'aidabautista85@yahoo.com'}, {'name': 'Warren Bacorro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aida Bautista, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Manila Doctors Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1008', 'city': 'Manila', 'state': 'NCR', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Warren Bacorro, MD', 'role': 'CONTACT', 'email': 'warren.bacorro.gs@ust.edu.ph'}, {'name': 'Teresa Sy Ortin, MD', 'role': 'CONTACT', 'email': 'ttsy-ortin@ust.edu.ph'}, {'name': 'Warren Bacorro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Teresa Sy Ortin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gil Gonzalez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Irene Tagayuna, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gonzalo Banuelos, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jennifer Madera, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Santo Tomas Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'centralContacts': [{'name': 'Warren Bacorro, MD', 'role': 'CONTACT', 'email': 'warren.bacorro.gs@ust.edu.ph', 'phone': '+639171665927'}], 'overallOfficials': [{'name': 'Warren Bacorro, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Santo Tomas Hospital - Benavides Cancer Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Five years after study completion', 'ipdSharing': 'YES', 'description': 'All data generated in this study will remain confidential and will be stored securely at the University of Santo Tomas Hospital - Benavides Cancer Institute and will be made available upon request and upon approval of the study team.', 'accessCriteria': 'Data will only be made available to people directly involved with the study or requesting and approved parties who have signed a Confidentiality Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Santo Tomas Hospital, Philippines', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Santo Tomas - Graduate School', 'class': 'UNKNOWN'}, {'name': 'University of Santo Tomas - Faculty of Medicine and Surgery', 'class': 'UNKNOWN'}, {'name': 'University of Santo Tomas Hospital - Benavides Cancer Institute', 'class': 'UNKNOWN'}, {'name': 'Philippine Council for Health Research & Development', 'class': 'OTHER_GOV'}, {'name': 'Manila Doctors Hospital', 'class': 'NETWORK'}, {'name': 'Our Lady of Lourdes Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Warren Bacorro', 'investigatorAffiliation': 'University of Santo Tomas Hospital, Philippines'}}}}