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

Locally Advanced Cervical Carcinoma Clinical Trial

— CECIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701735
• Other study ID #: USTH-BCI-RO-2022-02
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of Santo Tomas Hospital, Philippines
• Contact: Warren Bacorro, MD
• Phone: +639171665927
• Email: warren.bacorro.gs[@]ust.edu.ph
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Cervical Carcinoma
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• CECIL 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.

Locations

Country	Name	City	State
Philippines	Manila Doctors Hospital	Manila	NCR
Philippines	Our Lady of Lourdes Hospital	Manila	Metro Manila
Philippines	University of Santo Tomas Hospital	Manila	NCR

Sponsors (7)

Lead Sponsor	Collaborator
University of Santo Tomas Hospital, Philippines	Manila Doctors Hospital, Our Lady of Lourdes Hospital, Philippine Council for Health Research & Development, University of Santo Tomas - Faculty of Medicine and Surgery, University of Santo Tomas - Graduate School, University of Santo Tomas Hospital - Benavides Cancer Institute

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

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 Validati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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