A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Children's Oncology Group
- Enrollment
- 570
- Locations
- 181
- Primary Endpoint
- Proportion of patients with adherence rate greater than or equal to 95% to mercaptopurine as measured by MEMS®
Study Overview
Brief Summary
This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia that has had a decrease in or disappearance of signs and symptoms of cancer (remission). Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the impact of interventions proposed in intervention program (IP) versus (vs.) education alone (EDU) on adherence to oral 6MP (mercaptopurine) in children with acute lymphoblastic leukemia (ALL). Adherence will be measured by: i) Medication Event Monitoring Systems (MEMS) (primary measure of adherence to oral 6MP, providing real-time data; ii) red cell thioguanine nucleotide (TGN) levels (providing data on chronic, systemic 6MP exposure).
SECONDARY OBJECTIVES:
I. Examine the modifying effect of sociodemographic and psychosocial variables, and the mediating effect of health beliefs/ knowledge on change in adherence with intervention.
II. Determine impact of IP vs. EDU on risk of relapse of ALL.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of ALL, in first remission; enrollment on a Children Oncology Group (COG) therapeutic study for ALL is not required
- •At the time of enrollment, patient must have completed at least 24 weeks of maintenance chemotherapy, and is scheduled to receive at least 24 more weeks of maintenance chemotherapy
- •Receiving continuous oral 6MP during the maintenance phase of therapy for ALL (held only for toxicity or illness), and will be returning to the clinic every 4 weeks for scheduled appointments while enrolled on COG ACCL1033 (between days 1 and 141)
- •Has a designated parent or caregiver who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine
- •Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)
- •Parent/caregiver and patient (if 12 years and older) must be willing to use a cellular telephone to receive medication reminders via text messaging during study period
- •Patient and parent/caregiver must speak English or Spanish
- •All patients and/or their parents or legal guardians must sign a written informed consent
- •All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria
- •Patients with Down syndrome
- •Patients who previously participated in or are currently participating in another intervention clinical trial designed to improve adherence
Arms & Interventions
Arm I (intervention program and mercaptopurine)
See detailed description.
Intervention: Compliance Monitoring (Behavioral)
Arm I (intervention program and mercaptopurine)
See detailed description.
Intervention: Laboratory Biomarker Analysis (Other)
Arm I (intervention program and mercaptopurine)
See detailed description.
Intervention: Questionnaire Administration (Other)
Arm I (intervention program and mercaptopurine)
See detailed description.
Intervention: Behavioral Intervention (Behavioral)
Arm II (standard of care and mercaptopurine)
Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I. Patients and caregivers also view an interactive multimedia educational program on day 29.
Intervention: Compliance Monitoring (Behavioral)
Arm II (standard of care and mercaptopurine)
Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I. Patients and caregivers also view an interactive multimedia educational program on day 29.
Intervention: Laboratory Biomarker Analysis (Other)
Arm II (standard of care and mercaptopurine)
Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I. Patients and caregivers also view an interactive multimedia educational program on day 29.
Intervention: Mercaptopurine (Drug)
Arm II (standard of care and mercaptopurine)
Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I. Patients and caregivers also view an interactive multimedia educational program on day 29.
Intervention: Questionnaire Administration (Other)
Arm II (standard of care and mercaptopurine)
Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I. Patients and caregivers also view an interactive multimedia educational program on day 29.
Intervention: Standard Follow-Up Care (Procedure)
Arm I (intervention program and mercaptopurine)
See detailed description.
Intervention: Mercaptopurine (Drug)
Outcomes
Primary Outcomes
Proportion of patients with adherence rate greater than or equal to 95% to mercaptopurine as measured by MEMS®
Time Frame: 4 months
Compared between the IP and EDU groups using logistic regression. Mercaptopurine levels will be modeled as a function of time to examine longitudinal changes to 6TGN levels between the treatment groups using the generalized estimating equation (GEE) method for longitudinal normally distributed data.
Proportion of patients with adherence rate greater than or equal to 95% to mercaptopurine as measured by red cell TGN levels
Time Frame: 4 months
Compared between the IP and EDU groups using logistic regression. Mercaptopurine levels will be modeled as a function of time to examine longitudinal changes to 6TGN levels between the treatment groups using the GEE method for longitudinal normally distributed data.
Secondary Outcomes
- Proportion of adherence patients by sociodemographic and psychosocial variables(4 months)
- Mediating effect of health beliefs/ knowledge on change in adherence with intervention(4 months)
- Impact of IP vs. EDU on risk of relapse in children with ALL(Up to 10 years)