针对青少年和年轻成人癌症患者的定制化用药依从性促进干预方案
针对青少年和青年癌症患者的个性化用药依从性促进干预方案
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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Meghan E. McGrady, PhD
- 电话号码：513-803-8044
- 邮箱：Meghan.McGrady@cchmc.org
学习地点
-
-
Kansas
-
Kansas City、Kansas、美国、66160
- 尚未招聘
- The University of Kansas Medical Center
-
接触：
- Carolyn Bates, PhD
- 邮箱：cbates4@kumc.edu
-
-
New York
-
New York、New York、美国、1003230702
- 尚未招聘
- Columbia University Irving Medical Center
-
接触：
- Melissa Beauchemin, PhD
- 邮箱：mmp2123@cumc.columbia.edu
-
-
Ohio
-
Cincinnati、Ohio、美国、45229
- 招聘中
- Cincinnati Children's Hospital Medical Center
-
接触：
- Meghan E McGrady, PhD
- 电话号码：513-803-8044
- 邮箱：Meghan.McGrady@cchmc.org
-
-
Washington
-
Seattle、Washington、美国、98105
- 招聘中
- Seattle Children's Hospital
-
接触：
- Tyler Ketterl, MD
- 邮箱：Tyler.Ketterl@seattlechildrens.org
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Tailored Program
8-week program including 4 coach visits and 4 text check-ins |
Participants will participate in 4 sessions with a coach, 1 every other week. During these sessions, the participant will work with their coach to identify a barrier to adherence they would like to target. Then, they will work with their coach to create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text reminder about the plan. |
|
其他：Feedback Program (Uniform Standard of Care)
8-week feedback program including weekly texts |
Participants will receive weekly text messages with feedback about their adherence and guidance for requesting additional support if desired |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Medication Adherence
大体时间：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). |
The 1-month period following the completion of one of the study programs.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Life (Mental Health)
大体时间：Approximately 1 month after completing one of the study programs
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Mental Health 2a. Raw score range = 2-10. Higher scores = better quality of life. |
Approximately 1 month after completing one of the study programs
|
|
Quality of Life (Physical Health)
大体时间：Approximately 1 month after completing one of the study programs
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Physical Health 2a. Raw score range = 2-10. Higher scores = better quality of life. |
Approximately 1 month after completing one of the study programs
|
|
Healthcare Utilization
大体时间：6 months post-treatment
|
Number of oncology visits, lab draws, ED visits, and hospitalizations |
6 months post-treatment
|
合作者和调查者
合作者
调查人员
- 首席研究员：Meghan E. McGrady, PhD、Children's Hospital Medical Center, Cincinnati
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.