Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Prospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 6,000
- Locations
- 3
Study Overview
Brief Summary
Cancer is a leading cause of illness and death among children, adolescents, and young adults(CAYAs), especially in low- and middle-income countries(LMICs), where access to timely diagnosis and treatment is often limited. As a result, patients in these settings may experience higher rates of treatment complications, interruptions, and poorer outcomes compared with those in high-income countries (HICs).
This is a prospective, multicenter observational study that will follow children, adolescents, and young adults(CAYAs) with cancer who are receiving routine care at participating hospitals in low - and middle - income countries(LMICs). The study does not involve experimental treatments or changes to standard medical care. Information will be collected from medical records and from questionnaires that address access to care and social factors affecting treatment.
By describing treatment outcomes and the challenges patients and families face during cancer care, this study aims to provide data that can help inform future efforts to improve access to care and cancer outcomes in resource-limited settings.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must meet all the following criteria to be included in this study:
- •Age 0 to 21 years at study enrollment.
- •Diagnosed with cancer and receiving active treatment or undergoing follow-up at the participating sites.
- •a. Note: Patients seen solely for consultation or diagnostic evaluations without subsequent treatment and those who have been off treatment for more than 5 years and are seen only for survivorship follow-up are not considered as meeting this criterion.
- •Willingness to provide informed consent/assent. For minors incapable of providing assent, or individuals unable to provide consent, consent must be obtained from a legal representative and in accordance with local requirements.
Exclusion Criteria
- •Subjects meeting any of the following criteria must be excluded from this study:
- •1. Any medical or psychological condition that, in the investigator's opinion, might compromise the ability of the patient to provide assent/informed consent/assent.