The AYA Oncology Self-care Movement: An Influencer-driven Social Media Intervention for Oral Chemotherapy Adherence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Electronically-monitored Medication Adherence
研究概览
简要总结
This trial will test the impact of a social media intervention for improving oral chemotherapy adherence among adolescents and young adults (AYAs) with acute lymphoblastic leukemia.
详细描述
For adolescents and young adults (AYAs) who meet inclusion criteria, trained staff will introduce the study and confirm eligibility using a standardized checklist. For AYAs <18 years old, we will conduct enrollment with AYAs and their parent/legal guardian together, as we have successfully done before.
After study procedures are thoroughly explained and questions are answered, informed written eConsent and eAssent (AYAs <18) will be obtained. Across aims, AYAs will then complete a baseline questionnaire (assessing demographics, cancer information, and perceived medication adherence and self-management abilities). Electronic health record (EHR) review will also occur, with release forms obtained for AYAs outside our centers.
Trial data collection will occur over 6-months. All enrolled AYAs will complete baseline (T1) measures (~20 minutes) online via REDCap. All enrolled participants will be provided with and receive a tutorial on a validated electronic adherence monitor, which they will be instructed to use to monitor daily 6-MP adherence for the entire 6-month study period. For 28-days (i.e., the typical time between follow-up visits), all enrolled AYAs (both groups) will complete a run-in period involving electronic monitoring of 6-MP adherence only (no intervention) to calculate baseline adherence rates. On day 29, AYAs will complete a checklist about their usage of the electronic pill bottle (to problem-solve any barriers prior to randomization) and then be randomized to the #AYAOSM social media intervention or no message control.
Participants in both groups will be asked to continue using the electronic pill bottle to passively monitor 6-MP adherence over the next five months. Participants in both groups will also be provided with an educational website describing basic information about 6-MP.
#AYAOSM Intervention Group. For AYAs randomized to the social media condition, the intervention will begin on day 29 and last for 12 weeks. Across the 12-week intervention period, AYAs will receive ~2-3 distinct social media messages per week. Messages will be delivered using direct messaging to the participant's own social media account (e.g., TikTok or Instagram), from a study-created social media account.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15-25 years old
- •Diagnosed with acute lymphoblastic leukemia (ALL)
- •Taking 6-mercpatopurine (6-MP) as part of their maintenance treatment with at least 6-months remaining
- •Be able to speak and read English
- •Have at least one active social media account (e.g., Instagram, TikTok) or be willing to download a platform for the study
- •Endorse missing a 6-MP dose in the prior month and/or at least one adherence barrier.
排除标准
- •Cognitive impairments that would limit ability to complete measures, determined by the medical team
- •Absence of inclusion criteria above.
结局指标
主要结局
Electronically-monitored Medication Adherence
时间窗: 6-months
6-mercaptopurine (6-MP) adherence will be assessed using a Medication Event Monitoring System (MEMS), an electronic pill bottle cap that records bottle openings with date and time stamps. Adherence will be calculated as the percentage of prescribed days with a recorded bottle opening (number of days with openings/number of prescribed days × 100). The primary analysis will evaluate the proportion of participants achieving the clinically meaningful threshold of ≥95% adherent.
次要结局
- Medication Adherence Measure (4 items)(6-months)
- PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment - Short Form (8 items)(6-months)
- Theory of Planned Behavior Questionnaire (3 items)(6-months)
- PROMIS Emotional Support and Information Support - Short Forms (8 items each)(6-months)
- Objective engagement with social media intervention(12-week intervention period)
- Implementation barriers and facilitators(6-months)
研究者
Alex Psihogios
Assistant Professor
Northwestern University