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Effect of a Daily Text Messaging and Directly Supervised Therapy Intervention on Oral Mercaptopurine Adherence in
Smita Bhatia1, Lindsey Hageman1, Yanjun Chen1
1Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham.
Insights
This study found that a multicomponent intervention did not significantly improve mercaptopurine adherence in children with acute lymphoblastic leukemia (ALL). However, it showed promise for adolescents with low baseline adherence.
Area of Science:
- Pediatric Oncology
- Pharmacology
- Clinical Trials
Background:
- Suboptimal adherence to oral mercaptopurine in children with acute lymphoblastic leukemia (ALL) is linked to increased relapse risk.
- Forgetfulness is a common barrier to adherence, often managed by parental oversight.
Purpose of the Study:
- To compare a multicomponent intervention against education alone for improving mercaptopurine adherence rates (≥95%) in pediatric ALL patients.
- To analyze adherence differences based on age groups (younger than 12 vs. 12 years and older).
Main Methods:
- A multi-institutional, randomized clinical trial involving 444 pediatric ALL patients receiving mercaptopurine maintenance.
- Patients were randomized to receive either education alone or a package including education and daily text message reminders.
- Adherence was monitored for 4 weeks at baseline and then during a 16-week intervention period.
Main Results:
- The multicomponent intervention did not significantly increase the proportion of patients achieving ≥95% adherence compared to education alone (65% vs. 59%, P=.08).
- Exploratory analyses revealed higher mean adherence rates in older adolescents (≥12 years) within the intervention group (93.1% vs. 90.0%, P=.04).
- Specifically, older adolescents with baseline adherence <90% showed significantly improved adherence with the intervention (83.4% vs. 74.6%, P=.008).
Conclusions:
- The tested multicomponent intervention did not achieve the primary endpoint of improving overall mercaptopurine adherence in pediatric ALL.
- The study identified adolescents with low baseline adherence as a key subpopulation for targeted future interventions.
- No safety concerns were identified during the trial.
Importance:
Suboptimal adherence to oral mercaptopurine treatment in children with acute lymphoblastic leukemia (ALL) increases the risk of relapse. A frequently expressed barrier to adherence is forgetfulness, which is often overcome by parental vigilance.
Objective:
To determine whether a multicomponent intervention, compared with education alone, will result in a higher proportion of patients with ALL who have mercaptopurine adherence rates 95% or higher, for all study participants and among patients younger than 12 years and vs those aged 12 years and older.
Design, Setting, And Participants:
The adherence intervention trial was an investigator-initiated, multi-institutional, parallel-group, unblinded, randomized clinical trial conducted between July 16, 2012, and August 8, 2018, at 59 Children's Oncology Group institutions in the US, enrolling patients with ALL diagnosed through age 21 years and receiving mercaptopurine for maintenance. The date of final follow-up was January 2, 2019. Data analysis was performed from February to October 2019.
Interventions:
Patients were randomized 1:1 to education alone or the intervention package, which consisted of education and personalized text message reminders daily to prompt directly supervised therapy. Four weeks of baseline adherence monitoring were followed with a 16-week intervention.
Main Outcomes And Measures:
The primary end point was the proportion of patients with adherence rates 95% or higher over the duration of the intervention for all study participants, and for those younger than 12 years vs those aged 12 years and older.
Results:
There were 444 evaluable patients (median age, 8.1 years; interquartile range, 5.3-14.3 years), including 230 in the intervention group and 214 in the education group. Three hundred two patients (68.0%) were boys, 180 (40.5%) were non-Hispanic White, 170 (38.3%) were Hispanic, 43 (9.7%) were African American, and 51 (11.5%) were Asian or of mixed race/ethnicity. The proportion of patients with adherence rates 95% or higher did not differ between the intervention vs education groups (65% vs 59%; odds ratio, 1.33; 95% CI, 1.0-2.0; P = .08). Exploratory analyses showed that among patients aged 12 years and older, those in the intervention group had higher mean (SE) adherence rates than those in the education group (93.1% [1.1%] vs 90.0% [1.3%]; difference, 3.1%; 95% CI, 0.1%-6.0%; P = .04). In particular, among patients aged 12 years and older with baseline adherence less than 90%, those in the intervention group had higher mean (SE) adherence rates than those in the education group (83.4% [2.5%] vs 74.6% [3.4%]; difference, 8.8%; 95% CI, 2.2%-15.4%; P = .008). No safety concerns were identified.
Conclusions And Relevance:
Although this multicomponent intervention did not result in an increase in the proportion of patients with ALL who had mercaptopurine adherence rates 95% or higher, it did identify a high-risk subpopulation to target for future adherence intervention strategies: adolescents with low baseline adherence.
Trial Registration:
ClinicalTrials.gov Identifier: NCT01503632.
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