Clinical trial · Interventional
Decision Aid for Chemotherapy in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer
Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer (CECIL): Development, Validation and Clinical Testing
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: 1. What is the effectiveness of the decision aid in reducing decisional conflict? 2. What is the utility of the decision aid in preparing for decision-making? 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CECIL Patient Decision Aid | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
- measure
- Decisional conflict
- timeFrame
- Prior to the second consultation visit (for treatment decision and implementation planning), usually within one week
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Squamous, adeno- or adenosquamous histology * International Federation of Gynaecology and Obstetrics (FIGO) Stage I-B3, II-A2, II-B to IV-A * Contraindication to ChT, including but not limited to hydronephrosis, renal or cardiac dysfunction, frailty, or refusal * Grade 6 level English literacy * Informed consent Exclusion Criteria: * Other histologies * Metastatic disease * Other active cancers * 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 * Prior pelvic radiotherapy, brachytherapy, or chemotherapy * Pregnancy * Cognitive impairment or psychological disturbance limiting study compliance
References
Publications (1)
- RESULTBacorro 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. PMID 37677124