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Spots Global Cancer Trial Database for Bright Ideas - CIN Feasibility Study

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Trial Identification

Brief Title: Bright Ideas - CIN Feasibility Study

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

Study ID: NCT04929899

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 4 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Children's Hospital Los Angeles, Los Angeles, California, United States

Rutgers Cancer Institute, New Brunswick, New Jersey, United States

Inova Children's Hospital, Falls Church, Virginia, United States

Hospital for Sick Children, Toronto, Ontario, Canada

Contact Details

Name: Lee Dupuis, PhD

Affiliation: SickKids Research Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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