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

Trial Summary

What is the purpose of this trial?

This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Pediatric acute lymphoblastic leukemia (ALL) patients who miss 5% of 6-mercaptopurine (6-MP) doses within the 2-year 6-MP regimen have a 2.7-fold risk of cancer that comes back after a period of improvement (relapse). To address these families' needs, researchers have developed MedSupport, a theory-based multilevel intervention with targets at the organizational, healthcare team, and caregiver levels that is designed to address root barriers to medication adherence. This study is being done to better understand families' experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication.

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 data supports the effectiveness of the MedSupport Intervention treatment for acute lymphoblastic leukemia?

The research highlights the importance of supportive care in improving outcomes for children with acute lymphoblastic leukemia, especially in low- and middle-income countries. Effective supportive care, which is a key component of the MedSupport Intervention, can help manage treatment side effects and improve survival rates. ^{1 2 3 4 5}

What safety data exists for MedSupport Intervention in humans?

The research highlights the importance of supportive care in managing treatment-related toxicity and infections in children with acute lymphoblastic leukemia, which are critical for safety. Improved reporting of infectious adverse events in clinical trials helps in managing safety and toxicity effectively. ^{1 6 7 8 9}

How is the MedSupport Intervention treatment different from other treatments for acute lymphoblastic leukemia?

The MedSupport Intervention is unique because it focuses on providing supportive care, which is crucial for managing side effects and improving the quality of life for children with acute lymphoblastic leukemia, especially in low- and middle-income countries where supportive care is often inadequate. ^{1 2 10 11 12}

Research Team

Kara M. Kelly

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Supportive medical care for children with acute lymphoblastic leukemia in low- and middle-income countries. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Acute lymphoblastic leukemia of childhood. [2007]

3. Canada 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. [2021]

4. India pubmed.ncbi.nlm.nih.gov

Acute lymphoblastic leukemia: are Egyptian children adherent to maintenance therapy? [2015]

5. Italy 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. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Association of the clinical profile and overall survival of pediatric patients with acute lymphoblastic leukemia. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes after induction failure in childhood acute lymphoblastic leukemia. [2022]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Risk of adverse events after completion of therapy for childhood acute lymphoblastic leukemia. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Childhood leukemia: perspectives 1978. [2007]

11. Canada pubmed.ncbi.nlm.nih.gov

mHealth Supportive Care Intervention for Parents of Children With Acute Lymphoblastic Leukemia: Quasi-Experimental Pre- and Postdesign Study. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Supportive methods for childhood acute lymphoblastic leukemia then and now: A compilation for clinical practice. [2022]