Feasibility of a new approach to control nausea in children with leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility of a novel intervention designed to control chemotherapy-induced nausea in children with Acute Lymphoblastic Leukemia (ALL) who are receiving oral 6-mercaptopurine. The intervention, called Bright IDEAS-CIN, involves an 8-session problem-solving skill training program for caregivers, which includes both face-to-face and virtual sessions. The goal is to enhance the quality of life for patients by empowering families to manage treatment-related symptoms more effectively. If successful, this approach could be adapted for broader use in pediatric chemotherapy patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: ≥ 4 years (PeNAT validated in patients 4 to 18 yrs)
* newly diagnosed or recurrent disease: first diagnosis of ALL (i.e. non-relapsed) in maintenance therapy
* English, French or Spanish-speaking with an English, French or Spanish-speaking guardian (PeNAT available in these languages)
* without physical or cognitive impairments that preclude use of the PeNAT
* planned to receive PO 6-mercaptopurine
* not planned to receive IV, IM, SC or IT chemotherapy or oral or IV corticosteroids during the 7-day study period

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Rutgers Cancer Institute
  New Brunswick, New Jersey, United States Recruiting
• Inova Children's Hospital
  Falls Church, Virginia, United States Recruiting
• Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Lee Dupuis, PhD — SickKids Research Institute
• Study coordinator: Lee Dupuis, PhD
• Email: lee.dupuis@sickkids.ca
• Phone: 416-813-7762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.