Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer (CECIL): Development, Validation and Clinical Testing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Decisional conflict
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Routine care
Routine in-house workflow for initial and follow-up consultation, disclosure of diagnosis, and apprisal and counseling regarding treatment options
Patient decision aid
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
干预措施: CECIL Patient Decision Aid (Behavioral)
结局指标
主要结局
Decisional conflict
时间窗: 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.
次要结局
- 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)
研究者
Warren Bacorro
Principal Investigator
University of Santo Tomas Hospital, Philippines