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Bright Ideas- CIN Training for Acute Lymphoblastic Leukemia

N/A
Recruiting
Led By Lee Dupuis, PhD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months from study activation
Awards & highlights

Study Summary

This trial will compare how well two different methods work in controlling nausea caused by chemotherapy in children with leukemia.

Who is the study for?
This trial is for children aged 4 years or older with newly diagnosed or recurrent Acute Lymphoblastic Leukemia (ALL) who speak English, French, or Spanish. They must be in maintenance therapy and not planned to receive certain types of chemotherapy or steroids during the study. Participants also need to be able to use a nausea assessment tool without cognitive impairments.Check my eligibility
What is being tested?
The study tests if teaching problem-solving skills can help control nausea in children with ALL taking oral 6-mercaptopurine. It's a preliminary step to see if it's possible to do a larger trial on this approach for managing treatment-related nausea.See study design
What are the potential side effects?
Since the intervention involves training in problem-solving skills rather than medication, traditional side effects are not expected. However, there may be indirect effects related to stress or anxiety from participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 4 years old or older.
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I am in maintenance therapy for my first diagnosis of ALL without relapse.
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I am scheduled to take 6-mercaptopurine pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months from study activation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months from study activation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months
Secondary outcome measures
CIN and CIV incidence

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bright Ideas- CIN TrainingExperimental Treatment1 Intervention
The PSST will be delivered by a "trainer" in a minimum of three 30-minute to 1-hour sessions with a parent and patient (if developmentally appropriate). During the first session, the study team member will build rapport by understanding relevant personal background and medical information; introduce PSST and the Bright IDEAS paradigm; review the patients experience with nausea as reported in Phase 1 and at other times during treatment; promote problem-solving strategies and skills; and develop an anti-nausea action plan. During the second session, the trainer will discuss how well the prior action plan worked and reinforce successful outcomes or, if unsuccessful, return to the problem-solving steps to generate a new action plan. The third session will review progress on CINV control, assist in problem-solving as needed, and discuss how to continue to use the Bright IDEAS framework to resolve future issues with CINV or symptom management more broadly.

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
690 Previous Clinical Trials
6,945,403 Total Patients Enrolled
Rutgers Cancer Institute of New JerseyOTHER
70 Previous Clinical Trials
18,682 Total Patients Enrolled
Inova Fairfax HospitalOTHER
10 Previous Clinical Trials
7,604 Total Patients Enrolled

Media Library

Bright Ideas- CIN Training Clinical Trial Eligibility Overview. Trial Name: NCT04929899 — N/A
Acute Lymphoblastic Leukemia Clinical Trial 2023: Bright Ideas- CIN Training Highlights & Side Effects. Trial Name: NCT04929899 — N/A
Bright Ideas- CIN Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929899 — N/A
Acute Lymphoblastic Leukemia Research Study Groups: Bright Ideas- CIN Training

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals excluded from this research trial?

"This trial necessitates that participants have not yet reached their 19th birthday and are at least four years old."

Answered by AI

How many participants are being accepted into this medical experiment?

"Affirmative. The information found on clinicaltrials.gov indicates that this experiment, first posted on March 1st 2022 and recently updated on July 30th 2022 is actively recruiting participants. A total of 75 patients need to be enrolled from two distinct medical sites."

Answered by AI

Are there still spots available for potential participants in this research?

"According to the clinicaltrials.gov website, this medical trial is still in its recruitment phase, with initial postings beginning March 1st 2022 and the latest update occuring on July 30th 2022."

Answered by AI

Is it possible for me to enrol in this research undertaking?

"Patients with acute lymphoblastic leukemia (ALL), aged 4-18, are invited to participate in this trial that is aiming to enroll around 75 people."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bright Ideas - CIN Feasibility Study
Lee Dupuis 2022. "Bright Ideas - CIN Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04929899.
~25 spots leftby Jun 2025
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