Bright Ideas - CIN Feasibility Study

Acute Lymphoblastic Leukemia (ALL) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04929899
• Other study ID #: 1000073003
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: Lee Dupuis, PhD
• Phone: 416-813-7654
• Email: lee.dupuis[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia (ALL)
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Behavioral:
• Bright Ideas - CIN Training
Bright IDEAS is a validated problem-solving skill training intervention.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	Inova Children's Hospital	Falls Church	Virginia
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Rutgers Cancer Institute	New Brunswick	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Children's Hospital Los Angeles, Inova Fairfax Hospital, Rutgers Cancer Institute of New Jersey

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months	A future trial will be feasible if; 50% of patients deemed to be eligible to participate in Phase 1 consent/assent to participate; the recruitment into Phase 2 of 20 evaluable patients across all participating centers within 24 months of study activation of whom 80% return a completed CINV diary for at least 5 days of each 7-day data collection period. A completed CINV diary contains at least one PeNAT score and a record of the time of each vomiting episode or noting the presence/absence of vomiting daily. Evaluable patients are defined as those who have completed at least one cycle of PSST.	24 months from study activation
Secondary	CIN and CIV incidence	Proportion of children who report CIN and chemotherapy-induced vomiting (CIV) in Phase 1 and Phase 2	24 months from study activation