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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Philippines
Manila Doctors Hospital
RECRUITING
Manila
Our Lady of Lourdes Hospital
RECRUITING
Manila
University of Santo Tomas Hospital
RECRUITING
Manila
Contact Information
Primary
Warren Bacorro, MD
warren.bacorro.gs@ust.edu.ph
+639171665927
Time Frame
Start Date: 2023-02-20
Estimated Completion Date: 2024-12
Participants
Target number of participants: 45
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Manila Doctors 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, Our Lady of Lourdes Hospital
Leads: University of Santo Tomas Hospital, Philippines

This content was sourced from clinicaltrials.gov