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.

NCT04929899

Bright Ideas - CIN Feasibility Study

Recruiting
NAAges 4–18InterventionalSupportive care
The Hospital for Sick Children
~75 participants
Updated 2025-01-31 on ClinicalTrials.gov
What's tested:Bright Ideas - CIN Training

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months
Measured over 24 months from study activation
Acute Lymphoblastic Leukemia (ALL)

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.

  • Lee Dupuis, PhD · PRINCIPAL_INVESTIGATOR · SickKids Research Institute

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Eligibility criteria

Inclusion

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
  • 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.