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| Name | Class |
|---|---|
| University of Santo Tomas - Graduate School | UNKNOWN |
| University of Santo Tomas - Faculty of Medicine and Surgery | UNKNOWN |
| University of Santo Tomas Hospital - Benavides Cancer Institute | UNKNOWN |
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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.
The main questions it aims to answer are:
Participants will be asked to accomplish the Decisional Conflict Scale before and after using the decision aid.
Researchers will compare patients given routine care and the decision aid with patients given routine care to see if the decision aid reduces decisional conflict.
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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine care | No Intervention | Routine in-house workflow for initial and follow-up consultation, disclosure of diagnosis, and apprisal and counseling regarding treatment options | |
| Patient decision aid | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CECIL Patient Decision Aid | Behavioral | 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. The decision aid will be developed and validated according to the guidelines and standards published by the International Patient Decision Aids Standards (IPDAS) Collaboration. |
| Measure | Description | Time Frame |
|---|---|---|
| Decisional conflict | 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. | Prior to the second consultation visit (for treatment decision and implementation planning), usually within one week |
| Measure | Description | Time Frame |
|---|---|---|
| Utility in preparation for decision-making | 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. | After use of the patient decision aid and prior to the second consultation visit (for treatment decision and implementation planning), usually within one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Warren Bacorro, MD | Contact | +639171665927 | warren.bacorro.gs@ust.edu.ph |
| Name | Affiliation | Role |
|---|---|---|
| Warren Bacorro, MD | University of Santo Tomas Hospital - Benavides Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady of Lourdes Hospital | Recruiting | Manila | National Capital Region | 1016 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37677124 | Result | 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. |
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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.
Five years after study completion
Data will only be made available to people directly involved with the study or requesting and approved parties who have signed a Confidentiality Agreement.
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Philippine Council for Health Research & Development | OTHER_GOV |
| Manila Doctors Hospital | NETWORK |
| Our Lady of Lourdes Hospital | UNKNOWN |
Phase 1: Embedded mixed-methods design Phase 2: Experimental, block-randomized two-arm trial design
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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.
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| Manila Doctors Hospital | Recruiting | Manila | NCR | 1000 | Philippines |
|
| University of Santo Tomas Hospital | Recruiting | Manila | NCR | 1008 | Philippines |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |