A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Tailored Program
  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.
• Поведенческое Feedback Program (Uniform Standard of Care)
  Participants will receive weekly text messages with feedback about their adherence and guidance for requesting additional support if desired

Первичные конечные точки

• Medication Adherence [Срок оценки: The 1-month period following the completion of one of the study programs.]

Вторичные конечные точки (3)

• Quality of Life (Mental Health) [Срок оценки: Approximately 1 month after completing one of the study programs]
• Quality of Life (Physical Health) [Срок оценки: Approximately 1 month after completing one of the study programs]
• Healthcare Utilization [Срок оценки: 6 months post-treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Лечение

Центры проведения

США · 4 центра

• The University of Kansas Medical Center — Kansas City
• Columbia University Irving Medical Center — New York
• Cincinnati Children's Hospital Medical Center — Cincinnati
• Seattle Children's Hospital — Seattle

Идентификаторы

NCT: NCT07223463 · R37CA302422 · R37CA302422

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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