Tests problem-solving training for nausea during oral chemotherapy in children

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 4 to 18 with acute lymphoblastic leukemia (ALL) in maintenance therapy who take 6-mercaptopurine by mouth. It tests a skills training for controlling nausea caused by chemotherapy.

Age

4 to 18 years

Sex

All sexes can join.

Disease stage

First diagnosis of ALL (not relapsed), now in maintenance therapy.

Earlier treatment

Planned to receive 6-mercaptopurine by mouth. Not planned to receive chemotherapy by IV, IM, SC or IT, or corticosteroids by mouth or IV, during the 7-day study period.

Main reasons for not taking part

• Physical or cognitive impairments that prevent use of the PeNAT
• Not English, French or Spanish-speaking, or no guardian who speaks one of these languages
• Planned chemotherapy by IV, IM, SC or IT during the 7-day study period
• Planned corticosteroids by mouth or IV during the 7-day study period

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 4 and 18 years old?YesNo

What the trial wants to find out

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.

The group in the trial

• Bright Ideas- CIN TrainingOther group

  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.