Helps families give children with leukemia their daily medicines at home

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for parents of children with acute lymphoblastic leukemia (ALL) who take 6-mercaptopurine (6-MP). It studies how to help families give the medicine at home.

Age

The child must be 365 days to under 19 years old at study entry.

Sex

Parents of children of any sex can join.

Disease stage

The child has acute lymphoblastic leukemia (ALL).

Earlier treatment

The child's treatment must include 6-mercaptopurine (6-MP), given by mouth or by nasogastric (NG) tube.

Main reasons for not taking part

• Parent is unwilling or unable to follow the trial requirements

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• Arm A (MedSupport)Treatment being tested

  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.

  Treatment: Biospecimen Collection, Electronic Health Record Review, Interview, Medical Device Usage and Evaluation, and Survey Administration

• Arm B (usual care)Existing treatment, for comparison

  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.

  Treatment: Best Practice, Biospecimen Collection, Electronic Health Record Review, Interview, Medical Device Usage and Evaluation, and Survey Administration