Clinical trial · Interventional
Bright Ideas - CIN Feasibility Study
Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy
NCT04929899CI-TRIAL-00085375recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bright Ideas - CIN Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Bright Ideas- CIN Training
- description
- The PSST will be delivered by a "trainer" in a minimum of three 30-minute to 1-hour sessions with a parent and patient (if developmentally appropriate). During the first session, the study team member will build rapport by understanding relevant personal background and medical information; introduce PSST and the Bright IDEAS paradigm; review the patients experience with nausea as reported in Phase 1 and at other times during treatment; promote problem-solving strategies and skills; and develop an anti-nausea action plan. During the second session, the trainer will discuss how well the prior action plan worked and reinforce successful outcomes or, if unsuccessful, return to the problem-solving steps to generate a new action plan. The third session will review progress on CINV control, assist in problem-solving as needed, and discuss how to continue to use the Bright IDEAS framework to resolve future issues with CINV or symptom management more broadly.
- interventionNames
- Behavioral: Bright Ideas - CIN Training
Primary outcomes (1)
- measure
- Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months
- timeFrame
- 24 months from study activation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.