Decision aid for chemotherapy in patients with cervical cancer who can't tolerate cisplatin
Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer (CECIL): Development, Validation and Clinical Testing
This study tests a new decision-making tool to help women with cervical cancer who can't tolerate cisplatin feel more confident about their treatment choices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Santo Tomas Hospital, Philippines Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Manila, Metro Manila and 2 other locations) |
| Trial ID | NCT05701735 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a patient decision aid designed for women with locally advanced cervical cancer who are intolerant to cisplatin. The study aims to reduce decisional conflict and enhance decision-making preparedness among participants. It involves a mixed-methods approach to develop a prototype decision aid, followed by a block-randomized trial comparing standard care with the decision aid. Participants will complete the Decisional Conflict Scale before and after using the aid to assess its impact.
Who should consider this trial
Good fit: Ideal candidates are adult women with untreated locally advanced cervical cancer who have contraindications to cisplatin chemotherapy.
Not a fit: Patients with metastatic disease, other active cancers, or those who have previously received pelvic radiotherapy or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could empower patients to make more informed treatment decisions, potentially improving their treatment adherence and satisfaction.
How similar studies have performed: Other studies have shown that patient decision aids can significantly improve decision-making processes in cancer care, suggesting a positive outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Manila, Metro Manila and 2 other locations
- Our Lady of Lourdes Hospital — Manila, Metro Manila, Philippines (Recruiting)
- Manila Doctors Hospital — Manila, Ncr, Philippines (Recruiting)
- University of Santo Tomas Hospital — Manila, Ncr, Philippines (Recruiting)
Study contacts
- Study coordinator: Warren Bacorro, MD
- Email: warren.bacorro.gs@ust.edu.ph
- Phone: +639171665927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.