Идёт набор NCT06703567

IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4

Без фазы С лечением 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: Standard Policy, Standard Policy + GEP Information Film.
Кому может быть актуально: Состояния в реестре: Breast Cancer. Базовые параметры: от 18 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: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The primary aim of the study is to determine if provision of a patient information film about Oncotype DX improves patients' knowledge and understanding about Gene Expression Profiling (GEP) test and risk of recurrence results in early breast cancer (EBC) patients, identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.

Подробное описание

Advances made in our understanding of the molecular biology of breast cancer have improved diagnostic testing and therapeutic options available to patients. Importantly results from genomic testing provide more accurate tailoring of treatments potentially enhancing the benefit to harm ratio by only offering adjuvant chemotherapy to those patients at highest risk of recurrence, and sparing those at lower risk the unwanted side effects of cytotoxic treatment. Conversations about risks and optimal treatments can be complex.

To aid understanding about GEP tests many clinical teams provide patients with information leaflets about GEP testing. Unfortunately these are often written by either academic or commercial sponsors and designed to meet certain ethical and regulatory guidelines rather than effectively educate the end-user.

There is some evidence that user-friendly patient information films might enhance patient knowledge and understanding and are more accessible to certain individuals, especially those with low literacy.

IMPARTER project has developed eight-minute film explaining why Oncotype DX GEP tests is used in EBC, what it is, and how the results help determine whether or not chemotherapy is recommended as a useful treatment option.

This study wish to examine the utility of the information film in the clinic setting with EBC patients identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.

Вмешательства

Поведенческое Standard Policy
Patients will receive information about the GEP test by clinical teams
Поведенческое Standard Policy + GEP Information Film
Patients will receive information about the GEP test by clinical teams and, after consultation with physician, they will be sent a link to view the film regarding OncotypeDX

Первичные конечные точки

GEP Knowledge Evaluation [Срок оценки: 1 week]

Вторичные конечные точки (4)

Anxiety assessment [Срок оценки: 1 week]
Decision making assessment [Срок оценки: 1 week]
Reaction to uncertain situations assessment [Срок оценки: 1 week]
Physician confidence/satisfaction assessment [Срок оценки: 1 week]

Критерии участия

Критерии включения

First presentation of early stage breast cancer with all known disease surgically removed
Estrogen Receptor (ER) positive and Human Epidermal growth factor Receptor 2 (HER-2) negative
No clear decision on whether chemotherapy should be given as adjunct based on current prognostic criteria
Consented to GEP testing
Able to give full informed consent to IMPARTER study
Good comprehension of the Italian language
Access to internet connection and devices (e.g. smart phone, tablet, laptop or desktop computer)