Acute Lymphoblastic LeukemiaNCT06323044
MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence
A study testing Best Practice, Biospecimen Collection and Electronic Health Record Review in people with Acute Lymphoblastic Leukemia, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Best Practice, Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent of a child diagnosed with acute lymphoblastic leukemia (ALL)
- Child patient age 365 days to < 19 years at time of study entry.
- Parent's child patient's therapy must include 6-mercaptopurine (6-MP) administered orally or by nasogastric (NG) tube.
- Verbal fluency in English, or Spanish
- Parent has a smartphone or computer access 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.
Who cannot join
- Parent is unwilling or unable to follow protocol requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Kara M. Kelly, 716-845-2333, Kara.Kelly@RoswellPark.org
Kara M. Kelly
About this study
Official title: MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication Adherence
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the mean change in 6-mercaptopurine chemotherapy adherence as assessed by the MEMS from baseline (T1) to 6 months (T2) between pediatric patients with ALL randomized to MedSupport intervention versus usual care
- To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 12 months (T3) between pediatric patients with ALL randomized to MedSupport intervention versus usual care
SECONDARY OBJECTIVES;
- To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 6 months (T2) within pediatric patients with ALL randomized to MedSupport intervention versus usual care
- To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 12 months (T3) within pediatric patients with ALL randomized to MedSupport intervention versus usual care
EXPLORATORY OBJECTIVES:
- To compare the proportion of pediatric acute lymphoblastic leukemia (ALL) patients with 6-mercaptopurine chemotherapy adherence based on 6-MP metabolite analysis of peripheral blood biospecimens collected during the Consolidation II and Continuation phases of treatment in patients randomized to either MedSupport intervention or usual care. (PATIENT) II. To use statistical modeling to examine potential mechanisms/mediators (medication barriers verse [vs.] social support, medication beliefs) of intervention efficacy in patients randomized to either MedSupport intervention or usual care. (PATIENT) III. To use statistical modeling to explore potential moderators of intervention efficacy including child age, caregiver socioeconomic status, race, ethnicity, and household structure in patients randomized to either MedSupport intervention or usual care. (PATIENT) IV. To determine parent intervention uptake by examining engagement with the screening questionnaire among parents from the intervention arm as a percentage based upon the ratio of the number of screening questionnaires completed to the number of questionnaires the participant was eligible to complete. (CAREGIVER) V. To assess whether parents from the intervention arm engaged with the educational videos as a percentage based upon the ratio of the number of minutes of videos watched compared to the number of minutes of educational videos the participant was prompted to view. (CAREGIVER) VI. To examine the strategies that may hinder or support implementation within routine care by assessing how parents from the intervention arm rated the acceptability, appropriateness, and feasibility of the MedSupport intervention. (CAREGIVER) VII. To explore barriers and facilitators to adoption, feasibility, and sustainability of the MedSupport intervention by examining the responses of a sample of 20 parent participants from the intervention arm who participate in semi-structured qualitative interviews. (CAREGIVER) VIII. To determine healthcare provider uptake by examining documentation of 4 weeks of adherence/medication-related consultations from intervention arm patient's Electronic Health Record (EHR) following a medication barrier alert. (INSTITUTIONAL) IX. To examine strategies that may hinder or support implementation within routine care by assessing healthcare provider ratings of the acceptability, appropriateness, and feasibility of the MedSupport intervention. (INSTITUTIONAL) X. To explore barriers and facilitators to adoption, feasibility, implementation, organizational/contextual factors that support maintenance and cost of the MedSupport intervention by examining the responses of a sample of 20 healthcare providers who participated in semi-structured qualitative interviews. (INSTITUTIONAL)
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: 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 B: 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.
After completion of study intervention, participants are followed up at 1 year and 2 years.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Best Practice, Biospecimen Collection, Electronic Health Record Review, Interview, Medical Device Usage and Evaluation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Electronic Health Record ReviewOther
Ancillary studies
InterviewOther
Ancillary studies
Medical Device Usage and EvaluationOther
Receive MedSupport intervention
Medical Device Usage and EvaluationOther
Use MEMS device
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (MedSupport) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Survey Administration |
| Arm B (usual care) | Active comparator | 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. Receives: Other: Best Practice; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Will be summarized by timepoint (baseline, 6-months, and 1-year) and condition using descriptive statistics and graphical summaries. The primary analysis will model log adherence as a function of condition, timepoint, their two-way interaction, and random family (accounting for the longitudinal measures within a family unit) and site (accounting for between cancer center variability) effects using a linear mixed model (LMM). Bonferroni adjusted tests about the appropriate contrasts of model estimates will be used to compare: 1) the mean change in adherence within each condition, 2) retention of effect at 12-months within each condition, and 3) the mean change in adherence between conditions.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start11 Feb 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kara M Kelly, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323044
- Sponsor's protocol ID
- I-3920723
- Other IDs
- NCI-2024-01734, I-3920723, R01CA283501
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication Adherence
- ClinicalTrials.gov ID
- NCT06323044
- Acronym / sponsor ID
- I-3920723
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To compare the mean change in 6-mercaptopurine chemotherapy adherence as assessed by the MEMS from baseline (T1) to 6 months (T2) between pediatric patients with ALL randomized to MedSupport intervention versus usual care
- To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 12 months (T3) between pediatric patients with ALL randomized to MedSupport intervention versus usual care
SECONDARY OBJECTIVES;
- To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 6 months (T2) within pediatric patients with ALL randomized to MedSupport intervention versus usual care
- To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 12 months (T3) within pediatric patients with ALL randomized to MedSupport intervention versus usual care
EXPLORATORY OBJECTIVES:
- To compare the proportion of pediatric acute lymphoblastic leukemia (ALL) patients with 6-mercaptopurine chemotherapy adherence based on 6-MP metabolite analysis of peripheral blood biospecimens collected during the Consolidation II and Continuation phases of treatment in patients randomized to either MedSupport intervention or usual care. (PATIENT) II. To use statistical modeling to examine potential mechanisms/mediators (medication barriers verse [vs.] social support, medication beliefs) of intervention efficacy in patients randomized to either MedSupport intervention or usual care. (PATIENT) III. To use statistical modeling to explore potential moderators of intervention efficacy including child age, caregiver socioeconomic status, race, ethnicity, and household structure in patients randomized to either MedSupport intervention or usual care. (PATIENT) IV. To determine parent intervention uptake by examining engagement with the screening questionnaire among parents from the intervention arm as a percentage based upon the ratio of the number of screening questionnaires completed to the number of questionnaires the participant was eligible to complete. (CAREGIVER) V. To assess whether parents from the intervention arm engaged with the educational videos as a percentage based upon the ratio of the number of minutes of videos watched compared to the number of minutes of educational videos the participant was prompted to view. (CAREGIVER) VI. To examine the strategies that may hinder or support implementation within routine care by assessing how parents from the intervention arm rated the acceptability, appropriateness, and feasibility of the MedSupport intervention. (CAREGIVER) VII. To explore barriers and facilitators to adoption, feasibility, and sustainability of the MedSupport intervention by examining the responses of a sample of 20 parent participants from the intervention arm who participate in semi-structured qualitative interviews. (CAREGIVER) VIII. To determine healthcare provider uptake by examining documentation of 4 weeks of adherence/medication-related consultations from intervention arm patient's Electronic Health Record (EHR) following a medication barrier alert. (INSTITUTIONAL) IX. To examine strategies that may hinder or support implementation within routine care by assessing healthcare provider ratings of the acceptability, appropriateness, and feasibility of the MedSupport intervention. (INSTITUTIONAL) X. To explore barriers and facilitators to adoption, feasibility, implementation, organizational/contextual factors that support maintenance and cost of the MedSupport intervention by examining the responses of a sample of 20 healthcare providers who participated in semi-structured qualitative interviews. (INSTITUTIONAL)
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: 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 B: 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.
After completion of study intervention, participants are followed up at 1 year and 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (MedSupport) | Experimental | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Interview, Other: Medical Device Usage and Evaluation, Other: Survey AdministrationParticipants 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. |
| Arm B (usual care) | Active comparator | Other: Best Practice, Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Interview, Other: Medical Device Usage and Evaluation, Other: Survey AdministrationParticipants 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 may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Parent of a child diagnosed with acute lymphoblastic leukemia (ALL)
- Child patient age 365 days to < 19 years at time of study entry.
- Parent's child patient's therapy must include 6-mercaptopurine (6-MP) administered orally or by nasogastric (NG) tube.
- Verbal fluency in English, or Spanish
- Parent has a smartphone or computer access with an Internet connection.
Key exclusion criteria (1 listed)
- Parent is unwilling or unable to follow protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm B (usual care) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm A (MedSupport), Arm B (usual care) |
| Electronic Health Record ReviewAncillary studies | Other | Arm A (MedSupport), Arm B (usual care) |
| InterviewAncillary studies | Other | Arm A (MedSupport), Arm B (usual care) |
| Medical Device Usage and EvaluationReceive MedSupport intervention | Other | Arm A (MedSupport) |
| Medical Device Usage and EvaluationUse MEMS device | Other | Arm A (MedSupport), Arm B (usual care) |
| Survey AdministrationAncillary studies | Other | Arm A (MedSupport), Arm B (usual care) |
Primary outcome
Medication adherence
Time frame: Up to 1 year
Will be summarized by timepoint (baseline, 6-months, and 1-year) and condition using descriptive statistics and graphical summaries. The primary analysis will model log adherence as a function of condition, timepoint, their two-way interaction, and random family (accounting for the longitudinal measures within a family unit) and site (accounting for between cancer center variability) effects using a linear mixed model (LMM). Bonferroni adjusted tests about the appropriate contrasts of model estimates will be used to compare: 1) the mean change in adherence within each condition, 2) retention of effect at 12-months within each condition, and 3) the mean change in adherence between conditions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kara M Kelly principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Biospecimen Collection and Electronic Health Record Review in people with Acute Lymphoblastic Leukemia, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.