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Набор скоро начнётся NCT07724652

The AYA Oncology Self-care Movement

Без фазы С лечением Acute Lymphobkastic Leukemia Medication Adherence

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Educational Website, #AYAOSM.
Кому может быть актуально
Состояния в реестре: Acute Lymphobkastic Leukemia, Medication Adherence. Базовые параметры: 15 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The AYA Oncology Self-care Movement: An Influencer-driven Social Media Intervention for Oral Chemotherapy Adherence

Обзор

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.

Подробное описание

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.

Control Condition. AYAs who are randomized to the control will only receive the educational website and continue to monitor their 6-MP adherence electronically. They will not receive any of the social media messages during the 6-month period.

Following the intervention period, all participants will be asked to complete follow-up REDCap surveys of self-management variables at 4-months (T2) and 6-months (T3). In addition to self-management indices, AYAs from the social media group will complete a questionnaire measure of intervention acceptability at T2. Some AYAs will also be asked to complete an interview about their experiences with the intervention. Electronic pill bottles will be returned to the study team to download data at T3.

Вмешательства

  • Поведенческое Educational Website
    Website providing basic information about 6-mercaptopurine (e.g., type, what it is used for, strategies for remembering to take it)
  • Поведенческое #AYAOSM
    Social media messages (videos/images) that target medication self-management skills/knowledge, self-efficacy, and social support. Messages were created in collaboration with young adult cancer survivors who are also prominent content creators or "influencers".

Первичные конечные точки

  • Electronically-monitored Medication Adherence [Срок оценки: 6-months]
Вторичные конечные точки (6)
  • Medication Adherence Measure (4 items) [Срок оценки: 6-months]
  • PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment - Short Form (8 items) [Срок оценки: 6-months]
  • Theory of Planned Behavior Questionnaire (3 items) [Срок оценки: 6-months]
  • PROMIS Emotional Support and Information Support - Short Forms (8 items each) [Срок оценки: 6-months]
  • Objective engagement with social media intervention [Срок оценки: 12-week intervention period]
  • Implementation barriers and facilitators [Срок оценки: 6-months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • Cognitive impairments that would limit ability to complete measures, determined by the medical team
  • Absence of inclusion criteria above.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 4 центра
  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
  • Northwestern University — Chicago
  • The Children's Hospital of Philadelphia — Philadelphia
  • MD Anderson Cancer Center — Houston

Публикации

  • McGrady ME, Ketterl TG, Norris RE, Perentesis JP, Pettee D, Mara CA, Breen G, Pai ALH. Barriers to medication adherence among adolescents and young adults with cancer. Pediatr Blood Cancer. 2023 Mar;70(3):e30186. doi: 10.1002/pbc.30186. Epub 2023 Jan 5. PMID 36602026
  • Psihogios AM, El-Khatib A, Matos K, Rabbi M, Rossoff J, Dinner S, Zeng K, Picos R, Ahmed A, Patel EM, Fleisher L, Hunger SP, Pai A, Laurenceau JP, Rini C, Barakat LP, Schwartz LA, Murphy S, Yanez B. Human-Centered Design of a Personalized Digital Health Intervention to Improve Oral Chemotherapy Adherence in Adolescents and Young Adults With Hematologic Cancers. Pediatr Blood Cancer. 2025 Aug;72(8) PMID 40346736
  • Bhatia S, Landier W, Shangguan M, Hageman L, Schaible AN, Carter AR, Hanby CL, Leisenring W, Yasui Y, Kornegay NM, Mascarenhas L, Ritchey AK, Casillas JN, Dickens DS, Meza J, Carroll WL, Relling MV, Wong FL. Nonadherence to oral mercaptopurine and risk of relapse in Hispanic and non-Hispanic white children with acute lymphoblastic leukemia: a report from the children's oncology group. J Clin Oncol PMID 22564992
  • Psihogios AM, Roth M, Gomez C, Hekimian-Brogan E, McQueen C, Yanez B. Partnering With Social Media Influencers to Equitably Improve Adolescent and Young Adult Cancer Outcomes: A Novel Strategy to Support Cancer Care Delivery. JCO Oncol Pract. 2024 Jun;20(6):755-760. doi: 10.1200/OP.23.00449. Epub 2024 Feb 26. No abstract available. PMID 38408282

Идентификаторы

NCT: NCT07724652 · STU00224160 · R37CA299904

Первоисточники (государственные реестры)

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