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Bright Ideas - CIN Feasibility Study

Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
4 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks whether a future trial of problem-solving skills training is possible. The future trial would test whether this training helps control nausea from chemotherapy in children with acute lymphoblastic leukemia (ALL), a blood cancer, who take 6-mercaptopurine by mouth.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 4 or older.
  • Have ALL diagnosed for the first time, not cancer that has come back.
  • Be in maintenance treatment, which helps keep the cancer from coming back.
  • Speak English, French, or Spanish, and have a guardian who speaks one of these languages.
  • Be able to use PeNAT, a tool for rating nausea, without physical or thinking problems that prevent its use.
  • Plan to take 6-mercaptopurine, a chemotherapy drug, by mouth.
  • Have no planned chemotherapy through a vein, into a muscle, under the skin, or into spinal fluid during the 7-day study.
  • Have no planned steroid medicines by mouth or through a vein during the 7-day study.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    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

    Study sites (3)

    CA

    NJ

    VA