Feasibility of a new approach to control nausea in children with leukemia
Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy
NA · The Hospital for Sick Children · NCT04929899
This study is testing a new program to help parents learn how to better manage nausea in children with leukemia who are undergoing chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children (other) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Los Angeles, California and 3 other locations) |
| Trial ID | NCT04929899 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 years and older who are newly diagnosed with Acute Lymphoblastic Leukemia and are scheduled to receive oral 6-mercaptopurine.
Not a fit: Patients who are not receiving oral chemotherapy or those with physical or cognitive impairments that prevent participation in the training may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for children undergoing chemotherapy by effectively managing nausea.
How similar studies have performed: While this specific approach is novel, similar interventions focusing on symptom management in pediatric oncology have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California and 3 other locations
- 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
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.
Conditions: Acute Lymphoblastic Leukemia