Clinical Trial: Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL

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 in 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 Summary:

PRIMARY OBJECTIVES:

I. Determine the impact of interventions proposed in intervention program (IP) 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.

OUTLINE: Patients are randomized to 1 of 2 intervention arms.

ARM I: Patients receive the Patients Supply Kit containing an electronic pill monitoring system, a MEMS® medication bottle with TrackCap™ with standard resistant cap, and written instructions for the patient and pharmacist. Parents and/or caregivers are also trained to supervise patients' intake of the medication. Beginning on day 1, patients start using the MEMS® medication bottle with TrackCap™. Clinical research assistants contact patients and parents by telephone the next day to confirm that TrackCap™ is being used, to identify any obstacles, and to determine solutions. Beginning on day 29, patients and caregivers view an interactive multimedia educational program on-line or via DVD. Patients also receive a customized electronic mercaptopurine schedule and automated customized text message reminders delivered via cellular
Sponsor: Children's Oncology Group

Current Primary Outcome:

  • 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.


Original Primary Outcome: Adherence rate to 6MP defined as the ratio of MEMS pill container openings to the number of days that 6MP doses were prescribed during each study month

Current Secondary Outcome:

  • Proportion of adherence patients by sociodemographic and psychosocial variables [ Time Frame: 4 months ]
    Evaluated analytically by logistic regression methods.
  • Mediating effect of health beliefs/ knowledge on change in adherence with intervention [ Time Frame: 4 months ]
    Evaluated analytically by logistic regression methods.
  • Impact of IP vs. EDU on risk of relapse in children with ALL [ Time Frame: Up to 10 years ]
    An intention-to-treat analysis will be used to compare the effectiveness of EDU and IP interventions in decreasing the risk of relapse. Cox proportional hazards regression models will be used to examine the impact of intervention on relapse. Covariates in the analysis will include clinical and sociodemographic predictors, and the intervention arm (IP vs. EDU).


Original Secondary Outcome: Effect of socio-demographic and clinical characteristics as well as health beliefs/knowledge on changes in adherence with the IP

Information By: Children's Oncology Group

Dates:
Date Received: January 3, 2012
Date Started: February 2012
Date Completion:
Last Updated: September 23, 2016
Last Verified: September 2016