IRB Study Number 21-876
Status Recruiting
Institutes Taussig Cancer Institute, Pediatric Institute
Description
2.1 Examine the role of factors in the patient domain (6MP adherence) and healthcare domain (6MP DI) associated with systemic exposure to 6MP (leukocyte DNA-TG levels).
2.1.1 Examine the association between 6MP adherence (patient domain) and DNA-TG levels. Hypothesis: 6MP adherence will correlate with leukocyte DNA-TG levels, after adjusting for 6MP DI and pharmacogenetics.
2.1.2 Examine the association between provider-prescribed 6MP DI (healthcare domain) and DNA-TG levels. Hypothesis: 6MP DI will correlate with leukocyte DNA-TG levels, after adjusting for 6MP adherence and pharmacogenetics.
2.2 In the patient domain, identify barriers/ facilitators to 6MP adherence among AYA with ALL using a mixed methods convergent parallel study design.
2.2.1 Quantitatively determine predictors of 6MP adherence. Hypothesis: Patient factors associated with 6MP adherence will include sociodemographics, psychosocial factors, health beliefs, relationships, and social support.
2.2.2 Qualitatively describe AYA patients’ perspectives regarding barriers/ facilitators to 6MP adherence. Hypothesis: Patient interviews will augment quantitative findings with in-depth understanding of barriers/ facilitators to 6MP adherence from an AYA perspective.
2.3 In the healthcare domain, identify barriers/ facilitators to disease management (provider-prescribed 6MP DI) among AYA with ALL, using a mixed methods convergent parallel study design.
2.3.1 Quantitatively identify healthcare factors associated with prescribed 6MP DI. Hypothesis: Factors associated with both healthcare structure (facility model and size, oncology practice model and size) and process (services, diagnostics, treatments) will be associated with disease management (prescribed 6MP DI).
2.3.2 Qualitatively describe healthcare providers’ perspectives regarding barriers/facilitators to disease management (6MP DI). Hypothesis: Provider interviews will augment quantitative findings with an understanding of healthcare barriers/ facilitators to disease management (6MP DI) in AYA ALL from the perspective of healthcare providers.
Inclusion Criteria
i) Diagnosis of ALL and in CR1 (first clinical remission) at entry into Maintenance
ii) ≥15 year and ≤39 years at study entry
iii) Ability to independently complete the study Adherence Questionnaires
iv) Receiving maintenance therapy with oral 6MP and MTX
v) At the time of study enrollment, received ≥24 weeks of maintenance and has ≥24 weeks remaining before end of maintenance
vi) English or Spanish-speaking
vii) Eligible diagnoses include Ph- precursor B-cell ALL, lymphoblastic lymphoma, T-cell ALL and Ph+ ALL
viii) Willing and able to use MEMS Track Cap for 6MP and MTX
Exclusion Criteria
i) Mature B-ALL (Burkitt leukemia)
ii) Patients presenting at consortium site for only a second opinion, second malignancy, or relapsed disease with previous treatment at another institution
iii) Down Syndrome; Fanconi Anemia
iv) Patients previously enrolled on a research study to measure or improve medication adherence
