Bright Ideas - CIN Feasibility Study

  • STATUS
    Recruiting
  • End date
    Dec 12, 2023
  • participants needed
    75
  • sponsor
    The Hospital for Sick Children
Updated on 12 August 2022

Summary

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.

Description

This study will evaluate a novel approach to controlling a treatment-related symptom that detracts significantly from the quality of life of many patients. It will preserve and enhance the patient's and family's autonomy with respect to self-care. If found to be effective, this approach may be generalizable to pediatric patients receiving chemotherapy other than 6-mercaptopurine and thus has the potential to improve the quality of life of many children receiving cancer therapy.

This study will evaluate the efficacy of Bright IDEAS-CIN, adapted from the validated Bright IDEAS framework to improve CIN control in children with ALL who experience nausea while receiving 6-mercaptopurine. Bright IDEAS is an 8-session face-to-face intervention with a caregiver. In this first session, the caregiver is taught the problem-solving framework and begins working on their first self-selected problem. Sessions 2-7 involve working through relevant problems, with most caregivers working through 3-4 different problems. The final session summarizes the skills and discusses how to continue to use these new skills for new problems instead of lapsing into old ineffective strategies. Investigators adapted Bright IDEAS to meet the specific problem of CINV by adapting it to 3 sessions focused specifically on CINV, including the child in the conversation when developmentally appropriate and allowing the latter sessions to be conducted by phone or video-chat.

Details
Condition Acute Lymphoblastic Leukemia (ALL)
Treatment Bright Ideas - CIN Training
Clinical Study IdentifierNCT04929899
SponsorThe Hospital for Sick Children
Last Modified on12 August 2022

Eligibility

Yes No Not Sure

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
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