A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- Medication Adherence
研究概览
简要总结
The goal of this clinical trial is to learn if a tailored intervention can help make it easier for adolescents and young adults with cancer to take their medications. The main questions the researchers are trying to answer are:
- Does the tailored intervention increase adherence?
- Does the tailored intervention improve quality of life?
- Does the tailored intervention reduce health care utilization?
The researchers will compare the tailored intervention to a uniform standard of care intervention (an intervention designed to be similar to what is currently happening in clinical care) to see if the tailored intervention works to improve adherence.
Participants will:
- Use an electronic pill bottle or box to store their medication
- Participate in intervention sessions
- Complete surveys before the intervention, after the intervention, and 6-months later
详细描述
The proposed research includes a randomized clinical trial of a tailored adherence-promotion intervention (Tailored Program) as compared to uniform standard of care (Feedback Program) for adolescents and young adults with cancer. As part of this study, up to 160 adolescents and young adults (AYAs) with cancer will be randomized to one of these groups. Participants who enroll in this trial will be given an electronic pill bottle or box with a computer chip to store their medication. After using the electronic monitor for a few weeks to assess baseline adherence, participants who demonstrate non-adherence and have used the electronic monitor without difficulty will be asked to complete pre-treatment questionnaires. Next, participants will be randomly assigned to one of the two groups and complete their assigned program. Adolescents and young adults will continue to use the electronic monitor to store their medication until approximately a month after their program ends. After their program ends, participants will complete questionnaires at post-treatment and again about 6 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 15.00 to 24.99 years of age
- •Patient is diagnosed with cancer
- •Patient is prescribed an oral anticancer/antitumor agent or prophylaxis
排除标准
- •Patient is not fluent in English
- •Patient evidences significant cognitive deficits
- •Patient's medical status or treatment precludes participation
- •Patient enrolled on a medical trial requiring medication storage in a trial-provided container
- •Patient demonstrates greater than or equal to 95% adherence during run-in period
- •Patient declines to use or has difficulty using electronic adherence monitoring device during run-in
研究组 & 干预措施
Tailored Program
8-week program including 4 coach visits and 4 text check-ins
干预措施: Tailored Program (Behavioral)
Feedback Program (Uniform Standard of Care)
8-week feedback program including weekly texts
干预措施: Feedback Program (Uniform Standard of Care) (Behavioral)
结局指标
主要结局
Medication Adherence
时间窗: The 1-month period following the completion of one of the study programs.
Each participant will be given an electronic adherence monitoring device to store their medication. An electronic adherence monitoring device is a pill bottle or box with an embedded computer chip. The computer chip records each time the device is opened. These device openings, or actuations, will be compared with the patient's prescribed medication regimen to compute their adherence (defined as the percentage of doses taken as prescribed).
次要结局
- Quality of Life (Mental Health)(Approximately 1 month after completing one of the study programs)
- Quality of Life (Physical Health)(Approximately 1 month after completing one of the study programs)
- Healthcare Utilization(6 months post-treatment)