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Bright Ideas - CIN Feasibility Study

RECRUITINGN/ASponsored by The Hospital for Sick Children
Actively Recruiting
PhaseN/A
SponsorThe Hospital for Sick Children
Started2022-03-01
Est. completion2025-06
Eligibility
Age4 Years – 18 Years
Healthy vol.Accepted
Locations3 sites
View on ClinicalTrials.gov →

NCT04929899

Summary

In this study investigators will determine the feasibility of a future trial comparing chemotherapy-induced nausea control in children with ALL receiving oral 6-mercaptopurine who do and do not receive problem-solving skill training. This is a novel approach to controlling an important and common treatment-related symptom.

Eligibility

Age: 4 Years – 18 YearsHealthy volunteers accepted
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

Conditions2

Acute Lymphoblastic Leukemia (ALL)Cancer

Locations3 sites

California

1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
Lauren Guidrylguidry@chla.usc.edu

New Jersey

1 site
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Katie Devine, PhDkatie.devine@rutgers.edu

Virginia

1 site
Inova Children's Hospital
Falls Church, Virginia, 22042
Robin Dulmanrdulman@psvcare.org

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