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

February 22, 2024 updated by: Warren Bacorro, University of Santo Tomas Hospital, Philippines

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Philippines
    • Metro Manila
      • Manila, Metro Manila, Philippines, 1016
        • Recruiting
        • Our Lady of Lourdes Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Genalin Amparo, MD
        • Sub-Investigator:
          • Aris Luke Dungo, MD
    • NCR
      • Manila, NCR, Philippines, 1008
        • Recruiting
        • University of Santo Tomas Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Warren Bacorro, MD
        • Sub-Investigator:
          • Teresa Sy Ortin, MD
        • Sub-Investigator:
          • Gil Gonzalez, MD
        • Sub-Investigator:
          • Irene Tagayuna, MD
        • Sub-Investigator:
          • Gonzalo Banuelos, MD
        • Sub-Investigator:
          • Jennifer Madera, MD
      • Manila, NCR, Philippines, 1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine care
Routine in-house workflow for initial and follow-up consultation, disclosure of diagnosis, and apprisal and counseling regarding treatment options
Experimental: 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
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.

Other Names:
  • Decision Support Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional conflict
Time Frame: 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.
Prior to the second consultation visit (for treatment decision and implementation planning), usually within one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility in preparation for decision-making
Time Frame: 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.
After use of the patient decision aid and prior to the second consultation visit (for treatment decision and implementation planning), usually within one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santo Tomas Hospital, Philippines

Collaborators

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

Investigators

  • Study Chair: Warren Bacorro, MD, University of Santo Tomas Hospital - Benavides Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USTH-BCI-RO-2022-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Five years after study completion

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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