Digital Patient Support Program for Self-efficacy and Medication Adherence in Women on Adjuvant Endocrine Treatment for Breast Cancer
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: Sidekick digital patient support program for patients with breast cancer, Standard of care for breast cancer patients.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Cancer. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Iceland
- 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
Digital Patient Support Program for Self-Efficacy and Medication Adherence Amongst Women on Adjuvant Endocrine Treatment for Breast Cancer: A Randomized Controlled Trial
Обзор
This is a randomized, controlled study to assess the effect of Sidekick Health's digital program on self-efficacy and medication adherence in breast cancer patients prescribed adjuvant anti-hormonal treatment. Participants will be treated with the digital program in addition to standard of care (SoC), or SoC only.
Подробное описание
Sidekick Health has developed a digital patient support tool delivered via mobile application (app), to support people who have been diagnosed with breast cancer with self-efficacy in managing their symptoms and with medication adherence and holistic lifestyle modification. The Sidekick platform includes a medication center, including behavioral change material and tools aimed at improving adherence.
The study will be a 2-arm, parallel-group, randomized (1:1) controlled trial to evaluate the performance of Sidekick's digital patient support program for patients with breast cancer on patients' self-efficacy and medication adherence in women undergoing adjuvant endocrine treatment. 140 participants will be included, and eligible participants will be randomized to receive the Sidekick digital support program plus standard of care, or standard of care only.
Вмешательства
- Устройство Sidekick digital patient support program for patients with breast cancer
A digital health program delivered through an app that provides holistic lifestyle intervention and medication adherence support. - Другое Standard of care for breast cancer patients
Standard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation
Первичные конечные точки
- Self-efficacy and health education impact [Срок оценки: 12 weeks from baseline]
Вторичные конечные точки (12)
- Medication adherence according to MARS-5 questionnaire [Срок оценки: 12 weeks from baseline]
- Self-efficacy and health-education impact after 24 weeks and 1 year [Срок оценки: 24 weeks and 1 year]
- Medication adherence after 24 weeks and 1 year according to MARS-5 [Срок оценки: 24 weeks and 1 year]
- Adherence (PDC) to adjuvant endocrine treatment over 1 year [Срок оценки: 1 year]
- Medication persistence [Срок оценки: 1, 2, 3 and 5 years]
- BMI [Срок оценки: 12, 24 weeks and 1 year]
- Physical activity from IPAQ-SF [Срок оценки: 12, 24 weeks and 1 year]
- Endocrine treatment symptom management [Срок оценки: 12, 24 weeks and 1 year]
- Work status questionnaire [Срок оценки: 12, 24 weeks and 1 year]
- In app PRO on sleep, energy, stress, quality of life [Срок оценки: 12 and 24 weeks]
- User satisfaction in intervention group by MAUQ [Срок оценки: 12 weeks]
- Engagement, retention and overall activity in the digital intervention [Срок оценки: 12 and 24 weeks]
Критерии участия
Критерии включения
- Adult patient (18 years or older) diagnosed with breast cancer of stage I, II or III from 1st September 2023 or later
- Have been prescribed adjuvant endocrine therapy for breast cancer.
- Understands written and spoken Icelandic or English.
- Owns a smart-phone compatible with the Sidekick app and capable to use it
- Willing to download the Sidekick app on the smart-phone and to comply with the study measures and visits according to the protocol.
- Capable of providing informed consent for participating in the study.
Критерии исключения
- Having other concurrent conditions that in the opinion of the oncologist may compromise patient safety or study objectives.
- Concurrent participation in another clinical study in which the study treatment may confound the evaluation of the investigational program.
- Metastatic breast cancer (stage IV)
- Previous experience with Sidekick breast cancer program
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
Iceland · 1 центр
- Landspitali University Hospital — Reykjavik
Идентификаторы
NCT: NCT06989450 · BC-99-IS-002 · VSN24-126