A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Enrollment Rate
研究概览
简要总结
A pilot feasibility randomized clinical trial comparing a tailored intervention to uniform standard of care will be conducted. A total of 40 AYAs with cancer will be randomized to one of the two programs. Data will be collected to explore the hypotheses that the intervention meets pre-established enrollment, retention, fidelity, and data completion feasibility criteria and that AYAs will rate the intervention as easy to use and acceptable.
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. Up to 40 adolescents and young adults (AYAs) with cancer will be enrolled in this study. Participants who enroll in this trial will be given an eCAP electronic monitor, a pill bottle with a computer chip in the cap, to store their medication. After using the electronic monitor for 4 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 either the tailored adherence-promotion intervention group (Tailored Program) or the uniform standard of care group (Feedback Program). Participants will be assigned in a 1:1 ratio so that, at the end of the study, an equal number of participants will have been randomized to each group.
Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and 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 including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired.
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 post-treatment questionnaires regarding program usability and acceptability as well as their adherence.
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
- None
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 between 15 and 24 years of age
- •Patient diagnosis of cancer
- •Patient prescribed oral chemotherapy or prophylactic medication
排除标准
- •Patient is not fluent in English
- •Patient evidences significant cognitive deficits per medical team
- •Patient's medical status or treatment precludes participation per medical team, patient, or caregiver
- •Patient demonstrates greater than or equal to 95% adherence during run-in period
- •Patient declines to use electronic monitoring device
结局指标
主要结局
Enrollment Rate
时间窗: End of study enrollment period, approximately 12 months after enrollment initiation
Percent of approached eligible participants enrolling in the study
次要结局
- Retention Rate(From enrollment to study completion (approximately 4 weeks for patients deemed ineligible after run-in and approximately 16 weeks for patients deemed eligible after run-in))
- Intervention Fidelity: Contact(From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks))
- Intervention Fidelity: Length(From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks))
- Intervention Fidelity: Duration(From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks))
- Intervention Fidelity: Content(From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks))
- Assessment Completion(From enrollment to the completion of post-intervention assessment which occurred approximately 4 weeks after program completion (total time frame = approximately 16 weeks))
- System Usability Scale(Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment)
- "Adjective Rating Scale" (Measure of Usability)(Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment)
- Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater(Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment)
- Medical Adherence Measure(Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment)
- Electronically Monitored Medication Adherence(Starting 4 weeks prior to treatment initiation (approximately weeks 1-4) and continuing until 4 weeks after program completion (approximately weeks 12-16))