Risk-Based 6MP Adherence Enhancement Strategies in Children, Adolescent and Young Adults With ALL - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 64
- 试验地点
- 27
- 主要终点
- Participation
研究概览
简要总结
This clinical trial tests different programs to help patients with acute lymphoblastic leukemia (ALL) remember to take their medications during maintenance therapy at home. One problem with ALL maintenance treatment is remembering to take medicines at home like patients are supposed to. In maintenance, a medicine called 6-mercaptopurine or "6MP" is taken by mouth every day at home. In this study, 6MP prescriptions are filled into a special medication bottle called MEMS® which is fitted with a special cap called TrackCap™ that electronically records when the medication bottle is opened. Researchers are trying a new program to help patients be better at taking their 6MP like they're supposed to. This new program may help patients to remember to take their 6MP medication.
详细描述
PRIMARY OBJECTIVES:
I. Collect data on the feasibility of a phase 3 adherence-enhancing 2 parallel 2-arm randomized clinical trial.
Ia. Estimate participation rates, refusal reasons, and attrition rates. Ib. Evaluate rates of completeness of all aspects of the study (surveys [rates of missing elements]; MEMS® TrackCap™ return rates; maintenance form return rates from site clinical research assistants [CRAs]; blood samples for pharmacogenetics and deoxyribonucleic acid [DNA]-incorporated thioguanine nucleotide [DNA-TG] levels).
SECONDARY OBJECTIVES:
I. Among baseline non-adherers, estimate the impact of ultra-intensified intervention package (U-iIP) versus (vs.) intervention package (IP) on 6MP adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: >= 10 years and =< 25 years
- •Previously enrolled onto AALL1732
- •Consented to the AALL1732 mercaptopurine adherence correlative study
- •Maintenance therapy has not yet begun
- •English or Spanish-speaking (patient and parent/other adult)
- •Planning to receive 6MP (as tablets) during maintenance phase of therapy
- •Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)
- •Has a designated parent/other adult who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine
- •Patient/parent/other adult must be willing to use a smartphone to receive medication reminders
- •Receiving treatment at a Children's Oncology Group (COG) institution in the United States
排除标准
- •Patients who have previously participated in or are currently participating in another intervention clinical trial designed to improve adherence
- •Regulatory requirements
- •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
研究组 & 干预措施
Non-adherers arm I (IP)
See Detailed Description.
干预措施: Informational Intervention (Other)
Non-adherers arm I (IP)
See Detailed Description.
干预措施: Media Intervention (Other)
Non-adherers arm I (IP)
See Detailed Description.
干预措施: Medical Device Usage and Evaluation (Other)
Adherers arm III (EDU)
Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study.
干预措施: Informational Intervention (Other)
Adherers arm III (EDU)
Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study.
干预措施: Biospecimen Collection (Procedure)
Adherers arm III (EDU)
Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study.
干预措施: Media Intervention (Other)
Adherers arm III (EDU)
Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study.
干预措施: Medical Device Usage and Evaluation (Other)
Adherers arm III (EDU)
Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study.
干预措施: Questionnaire Administration (Other)
Adherers arm III (EDU)
Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study.
干预措施: Training and Education (Behavioral)
Adherers arm IV (pIP)
See Detailed Description.
干预措施: Biospecimen Collection (Procedure)
Adherers arm IV (pIP)
See Detailed Description.
干预措施: Compliance Monitoring (Behavioral)
Adherers arm IV (pIP)
See Detailed Description.
干预措施: Informational Intervention (Other)
Adherers arm IV (pIP)
See Detailed Description.
干预措施: Media Intervention (Other)
Adherers arm IV (pIP)
See Detailed Description.
干预措施: Medical Device Usage and Evaluation (Other)
Adherers arm IV (pIP)
See Detailed Description.
干预措施: Mercaptopurine (Drug)
Adherers arm IV (pIP)
See Detailed Description.
干预措施: Questionnaire Administration (Other)
Adherers arm IV (pIP)
See Detailed Description.
干预措施: Telephone-Based Intervention (Behavioral)
Adherers arm IV (pIP)
See Detailed Description.
干预措施: Training and Education (Behavioral)
Non-adherers arm I (IP)
See Detailed Description.
干预措施: Biospecimen Collection (Procedure)
Non-adherers arm I (IP)
See Detailed Description.
干预措施: Compliance Monitoring (Behavioral)
Non-adherers arm I (IP)
See Detailed Description.
干预措施: Health Promotion and Education (Other)
Non-adherers arm I (IP)
See Detailed Description.
干预措施: Mercaptopurine (Drug)
Non-adherers arm I (IP)
See Detailed Description.
干预措施: Questionnaire Administration (Other)
Non-adherers arm I (IP)
See Detailed Description.
干预措施: Telephone-Based Intervention (Behavioral)
Non-adherers arm I (IP)
See Detailed Description.
干预措施: Training and Education (Behavioral)
Non-adherers arm II (U-iIP)
See Detailed Description.
干预措施: Biospecimen Collection (Procedure)
Non-adherers arm II (U-iIP)
See Detailed Description.
干预措施: Compliance Monitoring (Behavioral)
Non-adherers arm II (U-iIP)
See Detailed Description.
干预措施: Health Promotion and Education (Other)
Non-adherers arm II (U-iIP)
See Detailed Description.
干预措施: Informational Intervention (Other)
Non-adherers arm II (U-iIP)
See Detailed Description.
干预措施: Media Intervention (Other)
Non-adherers arm II (U-iIP)
See Detailed Description.
干预措施: Medical Device Usage and Evaluation (Other)
Non-adherers arm II (U-iIP)
See Detailed Description.
干预措施: Mercaptopurine (Drug)
Non-adherers arm II (U-iIP)
See Detailed Description.
干预措施: Questionnaire Administration (Other)
Non-adherers arm II (U-iIP)
See Detailed Description.
干预措施: Telephone-Based Intervention (Behavioral)
Non-adherers arm II (U-iIP)
See Detailed Description.
干预措施: Training and Education (Behavioral)
结局指标
主要结局
Participation
时间窗: At baseline (by day 1 of maintenance chemotherapy)
Will calculate and report the proportion of patients eligible for the study who participate and will report a corresponding 95% confidence interval.
Refusal reasons
时间窗: At baseline (by day 1 of maintenance chemotherapy)
A single question in a study case report form prompts refusal reason. For each available reason, will calculate and report the proportion of patients reporting that refusal reason as well as corresponding 95% confidence intervals.
Attrition
时间窗: By 60 weeks from day 1 of maintenance chemotherapy
Will calculate and report the proportion of patients who drop out of the study prior to completion among those eligible and enrolled and will report the corresponding 95% confidence interval.
Completion of study measures
时间窗: By 60 weeks from day 1 of maintenance chemotherapy
Will calculate and report the proportion of patients who complete the following measures by the end of the study follow-up period: study survey submission, MEMS® TrackCap™ return, maintenance form return, and blood sample submission. Will also report the corresponding 95% confidence intervals.
次要结局
- 6-mercaptopurine (6MP) adherence (baseline non-adherers)(By 60 weeks from day 1 of maintenance chemotherapy)
- 6MP adherence (baseline adherers)(By 60 weeks from day 1 of maintenance chemotherapy)