Trial Title:
Decision Aid for Chemotherapy in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer
NCT ID:
NCT05701735
Condition:
Locally Advanced Cervical Carcinoma
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Patient decision aid
Cervical cancer
Chemotherapy
Radiotherapy
Elderly
Renal failure
Decisional conflict
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Phase 1: Embedded mixed-methods design Phase 2: Experimental, block-randomized two-arm
trial design
Primary purpose:
Other
Masking:
Triple (Participant, Care Provider, 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:
Intervention type:
Behavioral
Intervention name:
CECIL Patient Decision Aid
Description:
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.
Arm group label:
Patient decision aid
Other name:
Decision Support Intervention
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Our Lady of Lourdes Hospital
Address:
City:
Manila
Zip:
1016
Country:
Philippines
Status:
Recruiting
Contact:
Last name:
Warren Bacorro, MD
Phone:
09171665927
Email:
warren.bacorro.gs@ust.edu.ph
Contact backup:
Last name:
Genalin Amparo, MD
Email:
gingfabul@yahoo.com
Investigator:
Last name:
Genalin Amparo, MD
Email:
Sub-Investigator
Investigator:
Last name:
Aris Luke Dungo, MD
Email:
Sub-Investigator
Facility:
Name:
Manila Doctors Hospital
Address:
City:
Manila
Zip:
1000
Country:
Philippines
Status:
Recruiting
Contact:
Last name:
Warren Bacorro, MD
Email:
warren.bacorro.gs@ust.edu.ph
Contact backup:
Last name:
Aida Bautista, MD
Email:
aidabautista85@yahoo.com
Investigator:
Last name:
Warren Bacorro, MD
Email:
Principal Investigator
Investigator:
Last name:
Aida Bautista, MD
Email:
Sub-Investigator
Facility:
Name:
University of Santo Tomas Hospital
Address:
City:
Manila
Zip:
1008
Country:
Philippines
Status:
Recruiting
Contact:
Last name:
Warren Bacorro, MD
Email:
warren.bacorro.gs@ust.edu.ph
Contact backup:
Last name:
Teresa Sy Ortin, MD
Email:
ttsy-ortin@ust.edu.ph
Investigator:
Last name:
Warren Bacorro, MD
Email:
Principal Investigator
Investigator:
Last name:
Teresa Sy Ortin, MD
Email:
Sub-Investigator
Investigator:
Last name:
Gil Gonzalez, MD
Email:
Sub-Investigator
Investigator:
Last name:
Irene Tagayuna, MD
Email:
Sub-Investigator
Investigator:
Last name:
Gonzalo Banuelos, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jennifer Madera, MD
Email:
Sub-Investigator
Start date:
February 20, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
University of Santo Tomas Hospital, Philippines
Agency class:
Other
Collaborator:
Agency:
University of Santo Tomas - Graduate School
Agency class:
Other
Collaborator:
Agency:
University of Santo Tomas - Faculty of Medicine and Surgery
Agency class:
Other
Collaborator:
Agency:
University of Santo Tomas Hospital - Benavides Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Philippine Council for Health Research & Development
Agency class:
Other
Collaborator:
Agency:
Manila Doctors Hospital
Agency class:
Other
Collaborator:
Agency:
Our Lady of Lourdes Hospital
Agency class:
Other
Source:
University of Santo Tomas Hospital, Philippines
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05701735
