Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Adults With Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma Using Text Messages
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To compare adherence to oral chemotherapy between study groups for first treatment cycle (Efficacy Phase)
研究概览
简要总结
This is a single center 2-phase study to assess effects of using text messages on adherence to oral chemotherapy for patients with acute lymphoblastic leukemia (ALL) or T-cell lymphoblastic lymphoma.
详细描述
The study will begin with a 28-day pilot phase where participants will be asked to complete questionnaires to determine if the text message intervention is acceptable to participants.
In the efficacy phase, the study will compare adherence to oral mercaptopurine and methotrexate between those who receive the high intensity text message intervention and those who receive standard-of-care. It is believed that high-intensity text messages will increase patient adherence within cycle 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 39 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 15 years or older at time of enrollment
- •Diagnosed with ALL or T-cell lymphoblastic lymphoma
- •Currently receiving treatment with pediatric-based regimen that includes maintenance with mercaptopurine and methotrexate (e.g., CALGB 10403). Study participation begins with the start of maintenance, so enrollment occurs prior to the start of maintenance. Patients in the pilot phase may have already started maintenance as long as the end of their maintenance therapy is scheduled to occur after the end of the 28-day pilot intervention.
排除标准
- •Patient or caregiver who would receive text message reminders does not have a cell phone that receives text messages
- •Patient does not wish to participate
- •Text messages will be crafted in the patient's preferred language for medical communication, so English fluency is not an enrollment requirement.
结局指标
主要结局
To compare adherence to oral chemotherapy between study groups for first treatment cycle (Efficacy Phase)
时间窗: 84 days after completion of enrollment to efficacy phase of study
Adherence to chemotherapy regimen will be measured based on combined data from 8.1 Medication Event Monitoring System (MEMS) TrackCap devices which measure the number of times pill bottles are opened, responses to Medication Adherence Report Scale (MARS-5) questionnaire, number of pharmacy fills, and mean corpuscular volume (MCV) .
Feasibility of text message interventions to improve adherence to oral chemotherapy (Pilot Phase)
时间窗: 28 days after completion of enrollment to pilot phase of study
Feasibility will be measured based on participant responses to validated questionnaires - Feasibility of intervention measure (FIM) and Acceptability of intervention measure (AIM). Both forms are 4 items scored on a 5 point Likert scale. Scores greater than or equal to 16 will determine whether the intervention is feasible.
To compare adherence to oral chemotherapy with mercaptopurine and methotrexate
时间窗: 84 days
To compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for patients with ALL on pediatric-based regimens between those who receive the high intensity text message intervention and those who receive standard of care.
次要结局
- To compare adherence to oral chemotherapy between study groups for second treatment cycle (Efficacy Phase)(168 days after completion of enrollment to efficacy phase of study)
- To describe the relationship between oral chemotherapy adherence and patient factors(1 year)