Clinical trial NCT04929899: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia (ALL)
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Rutgers Cancer Institute of New Jersey
name: Inova Fairfax Hospital
name: Children's Hospital Los Angeles
First posted: 2021-06-18
Enrollment: 75
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months
timeFrame: 24 months from study activation
Secondary outcomes:
measure: CIN and CIV incidence
timeFrame: 24 months from study activation
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute
state: New Jersey
city: Falls Church
country: United States
facility: Inova Children's Hospital
state: Virginia
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: SickKids Research Institute
name: Lee Dupuis, PhD
role: PRINCIPAL_INVESTIGATOR
References: