Bright Ideas - CIN Feasibility Study
ConditionAcute Lymphoblastic Leukemia (ALL)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorThe Hospital for Sick Children
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Bright Ideas - CIN Training
BehavioralBright IDEAS is a validated problem-solving skill training intervention.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Bright Ideas- CIN TrainingOther 1 intervention
Trial outcomes
Primary outcomes
1
Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months
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.
Time frame
24 months from study activationSecondary outcomes
1
CIN and CIV incidence
Proportion of children who report CIN and chemotherapy-induced vomiting (CIV) in Phase 1 and Phase 2
Time frame
24 months from study activationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hospital for Sick Children
Lead sponsor
Rutgers Cancer Institute of New Jersey
Collaborator
Inova Fairfax Hospital
Collaborator
Children's Hospital Los Angeles
Collaborator
Source ClinicalTrials.gov