Storybook for Explaining Leukemia to Children

Overseen By Rosalia Soto

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Developmental delays, Cognitive delays, Chronic illnesses

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the storybook "Who is Luke Eemia?" can reduce stress for parents of children newly diagnosed with leukemia. It compares stress levels between parents using the storybook alongside standard support and those receiving only standard support. Ideal candidates are parents with a school-aged child (3-16 years old) recently diagnosed with leukemia or who have a sibling in this age range. Participants will complete surveys over several months to assess stress and comfort levels. The goal is to discover if the storybook helps parents feel more at ease and enhances their child's understanding of the condition. As an unphased trial, this study provides a unique opportunity for parents to explore new ways to support their family's emotional well-being.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants need to stop taking their current medications.

What prior data suggests that this storybook is safe for use with parents and children?

A previous study used the storybook "Who is Luke Eemia?" to help explain leukemia to children. As a storybook, not a medicine or medical device, it poses no safety concerns like those in drug trials. The storybook aims to provide emotional support and assist parents in discussing leukemia with their children. Designed as a helpful tool, it has no reported negative effects. Parents and children have found it useful for making conversations about leukemia easier and less stressful. ¹

Why are researchers excited about this trial?

The "Who is Luke Eemia?" storybook is unique because it offers a novel way for parents to explain leukemia to children. Unlike standard care options, which rely on verbal explanations and general child life support, this storybook serves as a tangible, interactive tool. Researchers are excited about this approach because it could make the process of explaining a complex medical condition more relatable and less stressful for both parents and children. By turning a serious diagnosis into a story, this method could improve understanding and emotional comfort, potentially reducing parental stress.

What evidence suggests that the storybook is effective for reducing parental stress in leukemia cases?

Research has shown that storybooks can reduce stress by helping parents explain complex medical conditions to their children. Studies on similar educational tools have demonstrated positive results in helping families understand and feel more comfortable with illness. In this trial, some parents will receive the "Who is Luke Eemia?" storybook. Early findings suggest that this book can lower parental stress by providing a clear and relatable way to discuss leukemia. This method might also help children better understand their situation, fostering a more supportive home environment. Using the storybook alongside standard support may help parents feel more prepared to handle their child's leukemia diagnosis. ¹

Who Is on the Research Team?

Erin Shields, MA

Principal Investigator

Children's Hospital Los Angeles

Kaitlin Bennett

Principal Investigator

Children's Hospital Los Angeles

Mandy Flores

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for parents or legal guardians of children aged 6-11 who have been newly diagnosed with leukemia. Participants will be involved in child life interventions and must be willing to complete surveys at three different times: when starting, at discharge, and about 3.5 months later.

Inclusion Criteria

I am the parent or guardian of a child aged 6-11 with a new leukemia diagnosis.

Parent/legal guardian is able to speak, read, and write English or Spanish, and give informed consent

I am the parent/guardian of a child under 6 or over 11, who has a sibling with new leukemia.

Exclusion Criteria

Their school-aged child does not give assent to participate

Their school-aged children have developmental or cognitive delays, and/or other chronic illnesses

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline Assessment

Parents complete the Parenting Stress Index Short Form and Comfort Survey prior to child life intervention

1 week

1 visit (in-person)

Child Life Intervention

Parents receive standard child life care or the storybook intervention, and complete the Discharge Survey and Storybook Assessment (Intervention Group only)

1 week

1 visit (in-person)

Follow-up

Parents complete the Parenting Stress Index Short Form about 3.5 months after baseline to assess long-term effects

3.5 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Who is Luke Eemia?

Trial Overview

The study is testing the impact of a storybook called 'Who is Luke Eemia?' on reducing parental stress compared to standard child life support alone. It also looks at whether the storybook helps improve understanding of leukemia for both parents and their children.

How Is the Trial Designed?

Group I: Intervention (Storybook) Group Experimental Treatment 1 Intervention

Parents in this group will receive the "Who is Luke Eemia?" storybook, and will receive guidance from the child life specialist on how to utilize the storybook with their school-aged child. Parents in this study will complete surveys at three timepoints, these surveys include: (1) Comfort Survey (prior to child life intervention), (2) Discharge Survey and (3) Storybook Assessment survey to review the parent's impression of the storybook intervention tool (about 1 week following the child life intervention), and the (4) Parenting Stress Index -4-Short Form (at baseline, at the time of the discharge survey, and about 3.5 months later).

Group II: Control Active Control 1 Intervention

Parents in this group will receive the standard child life interventional support for explaining the leukemia diagnosis to the school-aged patient/sibling. Parents in this study will complete surveys at three timepoints, these surveys include: (1) Comfort Survey (prior to child life intervention), (2) Discharge Survey (about 1 week following the child life intervention), and the (3) Parenting Stress Index-4-Short Form (at baseline, at the time of the discharge survey, and about 3.5 months later).

Who is Luke Eemia? is already approved in United States, European Union for the following indications:

Approved in United States as Gleevec for:

• Chronic myeloid leukemia (CML)
• Gastrointestinal stromal tumors (GISTs)
• Acute lymphoblastic leukemia (ALL)

Approved in European Union as Glivec for:

• Chronic myeloid leukemia (CML)
• Gastrointestinal stromal tumors (GISTs)
• Acute lymphoblastic leukemia (ALL)

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

A population pharmacokinetic (PPK) model for imatinib and its active metabolite in children and young adults was developed using data from 41 subjects, revealing that total body weight significantly influences drug clearance and volume of distribution.

The findings suggest that while current pediatric dosing guidelines are based on adult data, this new model can help optimize dosing and manage toxicities in children, ensuring safer and more effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics of imatinib mesylate and its metabolite in children and young adults. Menon-Andersen, D., Mondick, JT., Jayaraman, B., et al.[2015]

Adherence to oral chemotherapy regimens is crucial for achieving a cure in children with acute lymphoblastic leukemia (ALL), highlighting the importance of following treatment plans.

The study identifies race-specific factors that influence adherence to these regimens, suggesting that tailored support may be necessary to improve treatment outcomes across different racial groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It takes a village. Winick, N.[2021]

In a study of 92 children and adolescents with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), the addition of imatinib to intensive chemotherapy significantly improved 3-year event-free survival (EFS) to 80%, compared to historical controls at 35%.

The study found that adding imatinib did not increase toxicity compared to chemotherapy alone, and that the combination treatment was as effective as blood and marrow transplantation (BMT) in terms of EFS, suggesting a potential alternative to BMT for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: a children's oncology group study. Schultz, KR., Bowman, WP., Aledo, A., et al.[2022]

Imatinib mesylate, a tyrosine kinase inhibitor used for treating chronic myeloid leukemia and gastrointestinal stromal tumors, is generally well-tolerated, with most patients experiencing only mild side effects (grade 1 or 2).

Approximately 30% of patients on imatinib develop skin toxicity, with 5% experiencing high-grade reactions, including cases of extensive skin hyperpigmentation, which is linked to the drug's effect on melanocytes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpigmentation due to imatinib: A rare case of cutaneous involvement. Rehman, H., Hakim, N., Sugarman, R., et al.[2020]

In a review of 9 pediatric patients treated with imatinib mesylate for chronic myelogenous leukemia over 8 years, 88.9% experienced musculoskeletal pain, indicating a significant nonhematologic toxicity profile in children.

One-third of the patients had to discontinue therapy due to severe musculoskeletal pain, which is notably higher than the rates observed in adults, suggesting that pediatric patients may experience different and more severe side effects from imatinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonhematologic toxicity of imatinib mesylate in pediatric patients with chronic myelogenous leukemia: a predominance of musculoskeletal pain. Heym, KM., Gressett Ussery, SM., Trinkman, H., et al.[2015]

Imatinib mesylate (Gleevec) is recognized as the gold standard treatment for chronic myeloid leukemia, but it can cause cutaneous reactions that may restrict its use in some patients.

The case study presented demonstrates a successful progressive challenge for a patient who experienced a drug-induced rash from imatinib, suggesting that some patients may tolerate the medication after careful management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful progressive challenge after a cutaneous reaction to imatinib mesylate (Gleevec): a case report and review of the literature. Park, MA., Volcheck, GW., Guarderas, JC.[2016]

A retrospective study involving 41 pediatric patients with Neurofibromatosis type 1 (NF-1) treated with the MEK inhibitor selumetinib highlights the issue of cutaneous toxicity, which may affect patient adherence to treatment.

The authors propose a treatment algorithm to manage the skin-related side effects of selumetinib, aiming to improve adherence and overall treatment outcomes for these young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MEK inhibitor-induced paronychia in a paediatric population: A tertiary centre experience. Palmeiro, AG., Silva, L., Pimentel, B., et al.[2023]

Leukemia is the most common type of cancer in children in both Britain and the USA, highlighting its significant impact on pediatric health.

The report provides essential information for dentists on how to manage the dental care of children with leukemia, emphasizing the importance of understanding the medical aspects of the disease and its treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood leukemia and dental considerations. Williams, MC., Lee, GT.[2005]

Imatinib mesylate is an effective treatment for pediatric patients with chronic myeloid leukemia, but none of the patients achieved complete molecular remission with this therapy alone, indicating that it may not be sufficient for a cure.

Stem cell transplantation appears to be necessary for a potential cure, as 3 out of 6 patients who underwent the procedure achieved undetectable BCR-ABL levels, and the relapse-free survival rate at four years was 65.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical characteristics and treatment outcome of pediatric patients with chronic myeloid leukemia. Belgaumi, AF., Al-Shehri, A., Ayas, M., et al.[2021]

Imatinib mesylate (Glivec) is the standard first-line treatment for chronic myeloid leukemia (CML) due to its high response rates and favorable safety profile, but switching to a copy version of the drug may lead to treatment failure, as seen in two case studies.

In one case, a patient relapsed after switching to the copy drug, while another patient experienced severe complications and died shortly after the switch, highlighting the need for caution and further research on the safety and efficacy of copy versions of imatinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing therapy from Glivecto a "copy" imatinib results in a worsening of chronic myeloid leukemia disease status: two case reports. Asfour, IA., Elshazly, SA.[2023]

Citations

1.

withpower.com

withpower.com/trial/phase-leukemia-1-2024-d0639

Storybook for Explaining Leukemia to Children

Who is Luke Eemia? (Gleevec, Imatinib mesylate) is unique because it is a targeted therapy specifically designed to treat certain types of leukemia, like ...