Improving Chemotherapy-Induced Nausea Control Through Bright Ideas?-CIN Training: A Feasibility Study in Children Receiving Oral Chemotherapy.
Primary Objective:
To determine the feasibility of a future trial comparing chemotherapy-induced nausea (CIN) control in children with acute lymphoblastic leukemia (ALL) receiving oral 6-mercaptopurine who do and do not receive problem-solving skills training.
Secondary Objectives:
1) To describe the incidence of CIN and chemotherapy-induced vomiting (CIV) in children receiving oral 6-mercaptopurine for treatment of ALL in maintenance in children participating in Phase 1 and Phase 2.
2) To explore possible risk factors for CIN and CIV in children participating in Phase 1 including demographic factors, history of motion sickness, past CIV control, nudix hydrolase 15 (NUDT15) genotype and thiopurine methyltransferase (TPMT) genotype.
3) To describe strategies to control CIN explored by children and guardians
4) To explore age-based differences in responses to and satisfaction with Bright IDEAS.
Leukemia, not otherwise specified
- Rutgers Cancer Institute of New Jersey
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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