Locally Advanced Cervical Carcinoma
Conditions
Keywords
Patient decision aid, Cervical cancer, Chemotherapy, Radiotherapy, Elderly, Renal failure, Decisional conflict
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCECIL Patient Decision Aid
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.
Sponsors
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
Our Lady of Lourdes Hospital
University of Santo Tomas Hospital, Philippines
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Phase 1: Embedded mixed-methods design Phase 2: Experimental, block-randomized two-arm trial design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional conflict | Prior to the second consultation visit (for treatment decision and implementation planning), usually within one week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Utility in preparation for decision-making | After use of the patient decision aid and 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. |
Countries
Philippines
Contacts
Primary ContactWarren Bacorro, MD
Outcome results
None listed