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Идёт набор NCT06989489

Implementation of an Oral Chemotherapy Adherence Intervention

Без фазы С лечением Solid Tumor Hematologic Malignancy

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: Multilevel Adherence Intervention.
Кому может быть актуально
Состояния в реестре: Solid Tumor, Hematologic Malignancy. Базовые параметры: от 21 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 →

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Официальное название

Design and Implementation of a Social Cognitive Theory-based Medication Adherence Intervention

Обзор

The goal of this study is to evaluate the effectiveness and usability of a newly developed oral anticancer agent adherence program implemented across 6 cancer clinics (two academic, two urban, and two rural). The study will include 160 adult participants with either solid tumors or hematologic malignancies who have been taking oral anticancer agents for at least six months. This study will have two groups of participants, a pre- and post-implementation group. In the pre-implementation of the program group, investigators will administer a survey to the 80 participants and gather information about their medication prior to their enrollment of the program. Similarly, 80 participants who have been enrolled into this program for at least 6 months will serve as the post-implementation group. These patients will be administered the same survey. The results from both groups will be analyzed to see how effective the medication adherence program is.

Подробное описание

Participants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent. The pharmacists will review with all their patients, information including proper administration, side effects, symptom management, and treatment plans. Participants will continue to have these counseling sessions with their pharmacists, until the patient becomes stable on the oral anticancer agent.

Once stable, the participant will be placed into one of three monitoring risk categories (low risk, medium risk, high risk), by the pharmacist, based on several factors. Each of the three monitor categories will have different monitoring intervals where patients will interact with the pharmacists differently. Additionally, each patient will have follow-up appointments and will have access to further education and will be reassessed each time. Furthermore, additional help will be provided to each patient based on their needs. Depending on the monitoring category, participants may meet with their pharmacist more and communicate either through electronic surveys or in-person visits.

Вмешательства

  • Поведенческое Multilevel Adherence Intervention
    Participants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent based on their risk-stratified monitoring category. Participants will be followed longitudinally and will receive tailored support.

Первичные конечные точки

  • Oral Medication Adherence [Срок оценки: Baseline and week 4]
  • Acceptability [Срок оценки: After 6 months]
  • Appropriateness [Срок оценки: After 6 months]
  • Everyday use [Срок оценки: After 6 months]
Вторичные конечные точки (5)
  • Medication knowledge [Срок оценки: Baseline and 4 weeks]
  • Patient perception [Срок оценки: Baseline and 4 weeks]
  • Health literacy [Срок оценки: Baseline and 4 weeks]
  • Self-efficacy [Срок оценки: Baseline and 4 weeks]
  • Patient satisfaction [Срок оценки: Baseline and 4 weeks]

Критерии участия

Критерии включения

  • Adult (age ≥21 years-old) patients
  • Diagnosed with a solid or hematologic malignancy
  • Monotherapy on oral anticancer agent on treatment for at least 6 months

Критерии исключения

  • Patients on time-limited or intermittent therapy (non-continuous)
  • Patients on comfort (end-of-life) care
  • Patients enrolled on hospice

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

Здоровые добровольцы: Нет

Дизайн исследования

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

Центры проведения

США · 1 центр
  • UNC Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT06989489 · LCCC2125-AIM3 · K08CA279500

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗