Decision Aid for Chemotherapy in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer (CECIL)

Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer (CECIL): Development, Validation and Clinical Testing

University of Santo Tomas - Graduate School, University of Santo Tomas - Faculty of Medicine and Surgery, University of Santo Tomas Hospital - Benavides Cancer Institute, Philippine Council for Health Research & Development, Manila Doctors Hospital

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: What is the effectiveness of the decision aid in reducing decisional conflict? 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.

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 nonrandomized sequential comparison group pretest-post-test 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.

Patient decision aid, Cervical cancer, Chemotherapy, Radiotherapy, Elderly, Renal failure, Decisional conflict

Phase 1: Embedded mixed-methods design Phase 2: Quasi-experimental, non-randomized, sequential comparison-group pretest-posttest design

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. Therefore, the control group will not be made aware of a subsequent experimental group, and the experimental group will not be made aware of a prior control group.

Routine in-house workflow for initial and follow-up consultation, disclosure of diagnosis, and apprisal and counseling regarding treatment options

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

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.

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

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

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

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.

Data will only be made available to people directly involved with the study or requesting and approved parties who have signed a Confidentiality Agreement.