Behavioral Parenting Skills for Improving Pediatric Medication Adherence in Leukemia

Overseen By Elizabeth Bouchard, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must be taking: Oral anti-cancer

Disqualifiers: Non-ALL, No medication responsibility, others

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

Compensation: Varies

Number of Visits: 6

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the CareMeds intervention can help parents manage their child's leukemia medication more effectively. Researchers will compare usual care, which includes regular medical consultations, with the CareMeds program that provides special parent training sessions. The program targets parents of children aged 3-9 with acute lymphoblastic leukemia, who are responsible for administering their child's medication at home. The trial is open to parents fluent in either English or Spanish. As an unphased trial, it offers parents the chance to contribute to innovative approaches in managing their child's medication.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It seems focused on children already taking oral anti-cancer medication at home.

What prior data suggests that the CareMeds intervention is safe for improving pediatric medication adherence in leukemia?

Research has shown that the CareMeds program has been tested for acceptance and ease of use. In earlier studies, caregivers of children with cancer found the CareMeds sessions practical and well-received, indicating that families generally appreciate the program. However, these studies did not specifically address safety issues, likely because CareMeds is a skill-teaching program, not a medication.

Programs like CareMeds typically do not carry the same safety risks as drugs. They focus on teaching skills or changing behavior rather than using medications that might cause side effects, resulting in fewer safety concerns.

For those considering joining this trial, it's important to know that past participants have not reported any major safety issues with the CareMeds sessions. However, discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CareMeds Intervention because it offers a fresh approach to improving medication adherence in children with leukemia. Unlike standard treatment options that primarily focus on medical consultations and supportive care, CareMeds involves behavioral parent training sessions early in the treatment process. This method empowers parents with skills to better manage and support their child's medication routine, potentially leading to improved treatment outcomes. By targeting the behavioral aspects of medication adherence, CareMeds aims to address a critical component often overlooked in traditional care.

What evidence suggests that the CareMeds Intervention is effective for improving pediatric medication adherence in leukemia?

Research has shown that only about 54.55% of children with acute leukemia adhere to their medication schedule, highlighting the challenge of ensuring treatment at home. In this trial, one group of participants will receive the CareMeds Intervention, a program designed to help parents manage their children's medication schedules more effectively. Early results suggest that CareMeds is both acceptable and practical for caregivers of children with cancer. Although specific evidence of improved medication adherence is not yet available, the program addresses important caregiver needs, which is promising for helping children take their medicine properly. ^{1 3 6 7 8}

Who Is on the Research Team?

Elizabeth Bouchard, MD

Principal Investigator

Roswell Park Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for parents of children aged 3-9 with acute lymphoblastic leukemia (ALL), who are fluent in English or Spanish, understand the study's nature, and have signed consent. The child must be on home-based oral anti-cancer medication like 6-MP.

Inclusion Criteria

Parent has primary medication responsibility

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 taking cancer medication like 6-MP at home.

Exclusion Criteria

Parent does not have primary medication responsibility

My child does not have acute lymphoblastic leukemia nor is being treated for it.

My child is not currently taking any oral cancer medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CareMeds Intervention

Participants complete the CareMeds parent training sessions

3 weeks

3 visits (in-person)

Usual Care

Usual care group receives parent training sessions

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CareMeds Intervention

Trial Overview The CareMeds Intervention is being tested against usual care to see if it helps improve how well parents manage their child’s medication for ALL. This larger study involves multiple sites and aims to evaluate its acceptability and feasibility.

How Is the Trial Designed?

Group I: CareMeds Intervention Experimental Treatment 1 Intervention

Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.

Group II: Usual Care Active Control 2 Interventions

Usual care consists of medical consultations and supportive care, The usual care group will serve as a delayed intervention/wait list group for which 3 parent training sessions will be offered during weeks 13 through 15.

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

About half of the adolescents with cancer in the study reported perfect adherence to their medication regimens, with the most common reason for nonadherence being simply forgetting to take their medication.

Adolescents who had perfect adherence were more likely to have future-oriented goals and greater family social support, suggesting that interventions focusing on these areas could help improve adherence to cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical and psychosocial associates of nonadherence in adolescents with cancer. Hullmann, SE., Brumley, LD., Schwartz, LA.[2021]

In a study involving 40 parents of children with cancer, 42 pediatric oncology nurses, and 34 parents of healthy children, behavioral interventions like positive reinforcement and reprimands were generally viewed as moderately acceptable for addressing noncompliance.

Parents of children with cancer rated punitive strategies, such as response cost and time-out, as significantly less acceptable compared to nurses and parents of healthy children, highlighting the need for clinicians to consider treatment acceptability before implementing interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report: acceptance of behavioral interventions for children with cancer: perceptions of parents, nurses, and community controls. Miller, DL., Manne, S., Palevsky, S.[2019]

In a study of 77 children undergoing cancer treatment, adherence problems were linked to the child's age, with younger children struggling more with procedure-related tasks, and to the family's socioeconomic status, where lower SES families faced more issues with appointment timeliness and reporting treatment reactions.

Children with caregivers who practiced a more supportive parenting style experienced fewer cancellations and delays for appointments, suggesting that nurturing and responsive parenting can positively influence treatment adherence in pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment adherence difficulties among children with cancer: the role of parenting style. Manne, SL., Jacobsen, PB., Gorfinkle, K., et al.[2019]

The CareMeds intervention, designed to help caregivers of young pediatric cancer patients (ages 2-10) improve medication adherence, showed a 75% enrollment rate and a 100% retention rate, indicating strong feasibility.

Caregivers found the intervention sessions and materials acceptable, frequently using the skills taught, suggesting that this approach could effectively support medication adherence in young children and merits further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral parenting skills as a novel target for improving medication adherence in young children: Feasibility and acceptability of the CareMeds intervention. Bouchard, EG., Epstein, LH., Patel, H., et al.[2023]

In a study of pediatric patients with acute lymphoblastic leukemia, adherence rates to oral medications were found to be 85% for 6-mercaptopurine and 81% for methotrexate, indicating that many patients are not fully adhering to their treatment.

Adherence was particularly lower among patients aged 12 years and older, suggesting that targeted interventions are needed for this age group to improve medication adherence during maintenance therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Oral Medications During Maintenance Therapy Among Children and Adolescents With Acute Lymphoblastic Leukemia: A Medication Refill Analysis. Wu, YP., Stenehjem, DD., Linder, LA., et al.[2021]

In a study involving 64 interviews with patients and parents, it was found that nonadherence to leukemia maintenance therapy was primarily due to forgetfulness (15%) and poor tolerance, rather than intentional refusal, which was rare (8%).

Nonadherence was more common in older patients and was linked to factors such as the timing of therapy administration, lack of monitoring, socioeconomic status, and side effects, highlighting the need for regular screening for adherence issues during follow-up consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to leukemia maintenance therapy: a comparative study among children, adolescents, and adults. Mancini, J., Simeoni, MC., Parola, N., et al.[2015]

Nonadherence to oral chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL) can be as high as one third, highlighting a critical issue in treatment effectiveness.

A study involving 38 interviews and focus groups identified three key stages in the adherence process: recognizing the threat of leukemia, taking control of treatment, and managing medication over time, with parental responsibility being crucial for ensuring adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A grounded theory of the process of adherence to oral chemotherapy in Hispanic and caucasian children and adolescents with acute lymphoblastic leukemia. Landier, W., Hughes, CB., Calvillo, ER., et al.[2022]

Only 54.55% of children with acute leukemia demonstrated good medication adherence, indicating a significant challenge in home-based treatment management.

Factors influencing adherence included the child's age, caregiver occupation, and self-efficacy scores, suggesting that improving caregiver support and patient confidence could enhance adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication adherence in leukemia children receiving home-based treatment and its related factors. Zhong, D., Xiang, Q., Liu, Y., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10994065

Behavioral Parenting Skills as a Novel Target for Improving ... Despite decades of research we do not have effective strategies to meaningfully increase pediatric medication adherence.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9363525/

Feasibility and Acceptability of the CareMeds Intervention Overall, our findings show that the CareMeds intervention is an acceptable and feasible strategy for caregivers of pediatric cancer patients ...

3. withpower.com withpower.com/trial/behavioral-parenting-skills-for-improving-pediatric-medication-adherence-in-leukemia-27205

Behavioral Parenting Skills for Improving Pediatric ... Only 54.55% of children with acute leukemia demonstrated good medication adherence, indicating a significant challenge in home-based treatment management.

4. trialx.com trialx.com/clinical-trials/listings/291039/behavioral-parenting-skills-as-a-novel-target-for-improving-pediatric-medication-adherence-study-3/?&radius=10&place=A&user_country=Concord%20N

Behavioral Parenting Skills as a Novel Target for Improving ... Overview. The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/27527530241300056

Caregiver Medication Information Needs and ... This systematic review underscores the critical medication information needs of caregivers managing chemotherapy for children with cancer.

6. researchgate.net researchgate.net/publication/358510295_Behavioral_parenting_skills_as_a_novel_target_for_improving_medication_adherence_in_young_children_Feasibility_and_acceptability_of_the_CareMeds_intervention

Feasibility and acceptability of the CareMeds intervention The goal of this preliminary study was to assess the acceptability and feasibility of the CareMeds intervention. Caregivers of pediatric cancer patients (ages 2 ...

7. ahrq.gov ahrq.gov/news/newsletters/e-newsletter/848.html

Outpatient Medication Errors Prevalent Among Pediatric ... An AHRQ-supported study published in the journal Cancer found that 10 percent of children with leukemia or lymphoma experienced adverse drug ...

8. childlife.scholasticahq.com childlife.scholasticahq.com/article/127276-the-efficacy-of-procedural-support-interventions-on-coping-and-distress-for-children-with-newly-diagnosed-leukemia-a-prospective-pilot-study

The Efficacy of Procedural Support Interventions on Coping ... This study provides preliminary evidence that serial procedural support interventions provided by CCLS may be associated with reduced distress behaviors and ...