MedSupport Intervention for Acute Lymphoblastic Leukemia

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must be taking: Oral chemotherapy

Disqualifiers: Unwilling to follow protocol

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help families of children with acute lymphoblastic leukemia (ALL) manage the challenges of administering oral chemotherapy at home. Researchers seek to determine if the MedSupport intervention, a support and education program, can improve medication adherence, which is crucial because missed doses can lead to cancer recurrence. The trial includes two groups: one receiving usual care and the other receiving the MedSupport program, which provides personalized support and education. Families with children currently on oral 6-mercaptopurine (6-MP) treatment for ALL might be well-suited for this study. As an unphased trial, this study offers families an opportunity to contribute to research that could enhance support for managing ALL treatment at home.

Will I have to stop taking my current medications?

The trial does not specify whether participants must stop taking their current medications. However, since the study focuses on medication adherence for children with acute lymphoblastic leukemia, it is likely that participants will need to continue their current leukemia treatment, including 6-mercaptopurine (6-MP).

What prior data suggests that the MedSupport intervention is safe for pediatric patients with acute lymphoblastic leukemia?

Research has shown that the MedSupport program assists families in managing the challenges of administering oral chemotherapy to children with acute lymphoblastic leukemia. This program is not a drug or physical treatment; it is designed to help families adhere to medication schedules more effectively. Consequently, it poses no direct safety risks like those associated with new drugs.

The program involves identifying obstacles to medication adherence, providing personalized education, and enhancing communication with healthcare teams. Therefore, "safety" in this context means there are no harmful side effects to consider, as it is not a medical treatment. Instead, it serves as a supportive tool to help families maintain medication plans, offering only benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MedSupport Intervention for acute lymphoblastic leukemia (ALL) because it takes a unique approach by focusing on patient support and adherence to treatment. Unlike standard care, which typically involves regular medical consultations and supportive care, MedSupport offers a comprehensive strategy that includes universal screening to identify barriers to medication adherence, tailored virtual education to enhance understanding, and communication of these barriers to activate a multidisciplinary healthcare team. This method aims to improve patient outcomes by addressing the often-overlooked challenges of maintaining consistent treatment, potentially leading to better adherence and improved effectiveness of oral chemotherapy.

What evidence suggests that the MedSupport intervention is effective for improving medication adherence in pediatric acute lymphoblastic leukemia?

Research has shown that children with acute lymphoblastic leukemia (ALL) who do not follow their medication schedule face a much higher risk of cancer recurrence after treatment. Missing just 5% of their 6-mercaptopurine doses can increase this risk by 2.7 times. In this trial, participants in Arm A will receive the MedSupport intervention, a new program designed to help families manage the challenges of administering oral chemotherapy at home. The program focuses on identifying obstacles to medication adherence and providing personalized support to families and healthcare teams. Although specific data on MedSupport's effectiveness is not yet available, overcoming these barriers is crucial because better medication adherence is linked to improved outcomes for children with ALL. ^{2 5 6 7 8}

Who Is on the Research Team?

Kara M. Kelly

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for families of children with acute lymphoblastic leukemia. It aims to help those struggling with giving their child oral chemotherapy at home. Participants should be willing to undergo surveys, interviews, and use medical devices as part of the study.

Inclusion Criteria

Parent has a smartphone or access to a computer with an Internet connection

Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

My child is currently receiving their first treatment for ALL at a study site.

Exclusion Criteria

I, as a parent, cannot or will not follow the study rules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the MedSupport intervention or usual care for 12 months, including the use of MEMS device to track oral chemotherapy adherence and blood sample collection.

12 months

Follow-up

Participants are monitored for medication adherence and health outcomes at 1 year and 2 years post-intervention.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• MedSupport Intervention

Trial Overview The MedSupport intervention is being tested to see if it can identify and tackle the reasons why some kids don't take their medication properly. The study includes using electronic health records, collecting biospecimens, and evaluating how well a medical device works.

How Is the Trial Designed?

Group I: Arm A (MedSupport) Experimental Treatment 5 Interventions

Participants receive the MedSupport intervention consisting of three components: universal screening for adherence barriers, tailored virtual education enhancement, and communication of barriers to activate multidisciplinary healthcare teams for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.

Group II: Arm B (usual care) Active Control 6 Interventions

Participants receive usual care consisting of medical consultations and supportive care for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A survey of 49 parents and 15 adolescents with pediatric acute lymphoblastic leukemia (ALL) showed that all participants had access to mobile technology, indicating a strong potential for mobile health (mHealth) interventions to improve medication adherence.

Both parents and adolescents expressed a high interest in specific mHealth app features, such as medication lists, refill reminders, and reminders to take 6-mercaptopurine (6-MP), highlighting the need for tailored digital tools to support adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to Technology and Preferences for an mHealth Intervention to Promote Medication Adherence in Pediatric Acute Lymphoblastic Leukemia: Approach Leveraging Behavior Change Techniques. Heneghan, MB., Hussain, T., Barrera, L., et al.[2021]

Intensive chemotherapy has significantly improved survival rates for children with acute lymphoblastic leukemia, allowing for extended life expectancy.

In addition to medical treatment, providing attentive support for patients and their families is crucial for their overall well-being during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood leukemia: perspectives 1978. Komp, DM., Fortunato, RP.[2007]

Induction failure in pediatric acute lymphoblastic leukemia (ALL) occurs in 2.4% of cases and is linked to high-risk features such as older age, high leukocyte count, and specific genetic markers, leading to a low 10-year survival rate of only 32%.

Allogeneic stem-cell transplantation improves outcomes for T-cell leukemia patients, while children under 6 years with precursor B-cell leukemia and no adverse genetic features have a favorable 10-year survival rate of 72% when treated with chemotherapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after induction failure in childhood acute lymphoblastic leukemia. Schrappe, M., Hunger, SP., Pui, CH., et al.[2022]

In a study of 129 children with acute lymphoblastic leukemia (ALL) in Egypt, approximately 56% were found to be nonadherent to their oral maintenance chemotherapy with 6-mercaptopurine (6-MP), as assessed by questionnaires, and about 50% based on serum 6-MP levels.

Nonadherence was significantly linked to factors such as low socioeconomic status, lack of education, and larger family size, highlighting the need for targeted interventions to improve adherence in pediatric patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute lymphoblastic leukemia: are Egyptian children adherent to maintenance therapy? Khalek, ER., Sherif, LM., Kamal, NM., et al.[2015]

In a study of 109 children diagnosed with Acute Lymphoblastic Leukemia (ALL) in Brazil, the overall survival rate after 5 years was 71.5%, and the event-free survival rate was 65%, indicating a significant improvement in outcomes compared to previous years.

The study highlighted that a lack of prognostic testing for minimal residual disease and chromosomal abnormalities may have negatively impacted treatment outcomes, as many patients with unfavorable results did not undergo these critical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of the clinical profile and overall survival of pediatric patients with acute lymphoblastic leukemia. Correa, BT., Silva, GSS., Mendes, WJS., et al.[2023]

The study highlights the importance of accurately reporting infectious adverse events (AEs) in children with acute lymphoblastic leukemia (ALL) to better manage safety and toxicity during clinical trials.

Key processes implemented in two phase III trials included targeted toxicity identification, specific case report forms for infections, and real-time physician review, which have shown preliminary improvements in the reporting of infectious AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving infectious adverse event reporting for children and adolescents enrolled in clinical trials for acute lymphoblastic leukemia: A report from the Children's Oncology Group. Elgarten, CW., Thompson, JC., Angiolillo, A., et al.[2023]

Children with acute lymphoblastic leukemia in low- and middle-income countries (LMIC) have made progress in treatment, but their survival rates are still much lower than those in high-income countries due to inadequate supportive care.

The article provides essential supportive care recommendations for healthcare providers in LMIC, focusing on oncology nursing, management of complications like tumor lysis syndrome, nutritional support, and palliative care to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive medical care for children with acute lymphoblastic leukemia in low- and middle-income countries. Ceppi, F., Antillon, F., Pacheco, C., et al.[2015]

The long-term disease-free survival rate for childhood acute lymphoblastic leukemia has dramatically improved from less than 1% to 60% over the past 20 years, highlighting the effectiveness of current treatment strategies.

Key strategies for controlling the disease include intensive multiagent induction therapy, restoration of normal blood cell production, and tailored treatment based on individual relapse risk, emphasizing the importance of personalized medicine in improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute lymphoblastic leukemia of childhood. Steinherz, PG.[2007]

The AALL1131 trial found that substituting cyclophosphamide/etoposide for standard treatment in very high-risk B-cell acute lymphoblastic leukemia did not improve 4-year disease-free survival rates, which were 85.5% for the control group compared to 72.3% for the experimental group.

There were no significant differences in severe adverse events between the two treatment arms, indicating that the new regimen was not more harmful but also not more effective in improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replacing cyclophosphamide/cytarabine/mercaptopurine with cyclophosphamide/etoposide during consolidation/delayed intensification does not improve outcome for pediatric B-cell acute lymphoblastic leukemia: a report from the COG. Burke, MJ., Salzer, WL., Devidas, M., et al.[2020]

The mHealth supportive care intervention significantly reduced anxiety and uncertainty in illness among parents of children with acute lymphoblastic leukemia (ALL), with notable improvements in social function and knowledge about ALL and caregiving.

In a study involving 101 parents, those using the mHealth intervention reported greater satisfaction and a decreased need for additional knowledge compared to those receiving standard health education alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Supportive Care Intervention for Parents of Children With Acute Lymphoblastic Leukemia: Quasi-Experimental Pre- and Postdesign Study. Wang, J., Howell, D., Shen, N., et al.[2020]

Survival rates for childhood acute lymphoblastic leukemia have improved significantly due to advancements in treatment, including the introduction of targeted immune and molecular therapies, especially for relapsed cases.

Effective supportive care is crucial for the success of leukemia treatment, as inadequate support can lead to treatment failure and poor long-term outcomes; thus, updated guidelines are necessary to navigate the evolving landscape of supportive therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive methods for childhood acute lymphoblastic leukemia then and now: A compilation for clinical practice. Podpeskar, A., Crazzolara, R., Kropshofer, G., et al.[2022]

In a study of 827 children with acute lymphoblastic leukemia (ALL) who completed treatment, 16.9% experienced major adverse events within 10 years, including leukemic relapses and second malignancies.

The study identified that male sex is a significant predictor of leukemic relapse, highlighting the need for treatment strategies that not only reduce relapse rates but also minimize the risk of secondary cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of adverse events after completion of therapy for childhood acute lymphoblastic leukemia. Pui, CH., Pei, D., Sandlund, JT., et al.[2022]

Citations

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Clinical Characteristics and Outcomes of Acute ... Of the 15 patients who initiated treatment, 11 (73%) achieved remission after induction, one (7%) died during induction, two (13%) had ...

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The evolution of acute lymphoblastic leukemia research and ... The CALGB trial showed a 3-year survival rate of 73%. Hyper-CVAD-based therapy (also a pediatric-inspired regimen developed in 1992, and which ...

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Clinical Outcomes of Patients with Newly Diagnosed Acute ... Five-year EFS and OS rates were 22% and 38% for patients with pre-B ALL, 24% and 44% for patients with T ALL, and 13% and 27% for patients with Ph+ ALL. Median ...

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Improved outcome for children with acute lymphoblastic ... The 5-year event-free survival (EFS) improved from 30.6% in Era 1 to 64.2% in Era 2 (P<.001). Improvement in outcome was achieved without any significant ...

6. withpower.com withpower.com/trial/phase-precursor-cell-lymphoblastic-leukemia-lymphoma-2-2024-f68ef

MedSupport Intervention for Acute Lymphoblastic Leukemia This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia.

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Acute lymphoblastic leukemia: a comprehensive review ... The median response duration and the overall survival were 9 and 6 months, respectively. Based on these results, blinatumomab was approved by ...

8. ascopubs.org ascopubs.org/doi/10.1200/EDBK_280175

Recent Advances in Managing Acute Lymphoblastic ... The median survival was 7.4 months. These results led to a randomized trial comparing inotuzumab with physician's choice of chemotherapy in R-R ...