Bright Ideas - CIN Feasibility Study for ALL
This study is testing a new way to help children with Acute Lymphoblastic Leukemia (ALL), who are receiving the chemotherapy drug 6-mercaptopurine, manage nausea caused by their treatment. It's called "Bright Ideas - CIN Training" and teaches problem-solving skills. The study wants to see if it's possible to conduct a larger trial in the future. You might be able to join if you are between 4 and 18 years old, have newly diagnosed ALL and are in maintenance therapy, and speak English, French, or Spanish. The study will be considered successful if 20 eligible patients complete the study procedures within 24 months. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 75 participants. It is designed to evaluate the feasibility of a problem-solving skill training intervention.
- What's involved
- The intervention involves 8 face-to-face sessions with a caregiver, where they learn and practice problem-solving skills.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 24 months from study activation, focusing on patient consent and completion of study procedures.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Bright Ideas - CIN Feasibility Study
At a glance
Conditions
NCT04929899
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Children's Hospital Los Angeles
Los Angeles, Californiastudy coordinator listed
Recruiting
Hospital for Sick Children
Toronto, Ontario, Canadastudy coordinator listed
Recruiting
Inova Children's Hospital
Falls Church, Virginiastudy coordinator listed
Recruiting
Rutgers Cancer Institute
New Brunswick, New Jerseystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Lee Dupuis, PhD · PRINCIPAL_INVESTIGATOR · SickKids Research Institute
Who to contact
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Inclusion
What this trial measures
- Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months24 months from study activation
A future trial will be feasible if * 50% of patients deemed to be eligible to participate in Phase 1 consent/assent to participate * the recruitment into Phase 2 of 20 evaluable patients across all participating centers within 24 months of study activation of whom 80% return a completed CINV diary for at least 5 days of each 7-day data collection period. A completed CINV diary contains at least one PeNAT score and a record of the time of each vomiting episode or noting the presence/absence of vomiting daily. Evaluable patients are defined as those who have completed at least one cycle of PSST.