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Recruiting

Bright Ideas - CIN Feasibility Study

NCT04929899 · The Hospital for Sick Children
In plain English

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Official title
Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy
About this study
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.
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 design
Enrollment target: 75 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2022-03-01
Estimated completion: 2025-06
Last updated: 2025-01-31
Interventions
Behavioral: Bright Ideas - CIN Training
Primary outcomes
  • Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months (24 months from study activation)
Sponsor
The Hospital for Sick Children · other
With: Rutgers Cancer Institute of New Jersey, Inova Fairfax Hospital, Children's Hospital Los Angeles
Contacts & investigators
ContactLee Dupuis, PhD · contact · lee.dupuis@sickkids.ca · 416-813-7762
ContactTadi Hondonga · contact · Tadi.hondonga@sickkids.ca · 416-813-7654
InvestigatorLee Dupuis, PhD · principal_investigator, SickKids Research Institute
All locations (4)
Children's Hospital Los AngelesRecruiting
Los Angeles, California, United States
Rutgers Cancer InstituteRecruiting
New Brunswick, New Jersey, United States
Inova Children's HospitalRecruiting
Falls Church, Virginia, United States
Hospital for Sick ChildrenRecruiting
Toronto, Ontario, Canada
Bright Ideas - CIN Feasibility Study · TrialPath