Bright Ideas - CIN Feasibility Study

Last updated: January 28, 2025
Sponsor: The Hospital for Sick Children
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia (Pediatric)

Treatment

Bright Ideas - CIN Training

Clinical Study ID

NCT04929899
1000073003
  • Ages 4-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: Bright Ideas - CIN Training
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Rutgers Cancer Institute

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Inova Children's Hospital

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

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