Идёт набор NCT07354165

Financial Toxicity in Patients With Early-stage Breast Cancer

— Наблюдательное 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: Questionnaires.
Кому может быть актуально: Состояния в реестре: Breast Cancer. Базовые параметры: Без ограничений · 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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Официальное название

Assessing Prevalence of Financial Burden and Impact of Cancer on Financial toxicIty in Patients With Early-stage Breast Cancer

Обзор

Non-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for early-stage breast cancer patients does produce tangible changes of financial distress over the time and whether the determinants of financial distress change their relative weight over the time.

Подробное описание

PROFFIT questionnaire is an Italian instrument for evaluating FT in cancer patients in the Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT financial score) and 9 measuring possible determinants of FT. Primary aim of this study is to describe the rate of patients with early breast cancer experiencing financial toxicity (defined as a change of ≥18 points in the PROFFIT-score \[items 1-7\]) one year after the beginning of the first oncological treatment. In addition, among secondary aims of this study, we aim to verify whether FT is associated with quality of life response , and with disease free survival and overall survival.

Вмешательства

Другое Questionnaires
The PROFFIT questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where FT can be expressed and is formed by two type of items: (1) outcome (items 1-7) and (2) determinants (items 8-16). EORTC QLQ-C30, EORTC QLQ-BR42 and HADS questionnaires are currently used in clinical practice

Первичные конечные точки

Financial Toxicity at one year [Срок оценки: baseline visit (before surgery or chemotherapy/endocrine therapy depending on the cohort), at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires]

Вторичные конечные точки (4)

Changes in PROFFIT scores [Срок оценки: baseline, at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires, then every 6 months during endocrine therapy/other treatments/follow-up until 5 yrs from baseline]
Financial toxicity "Determinants" [Срок оценки: baseline, at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires, then every 6 months during endocrine therapy/other treatments/follow-up until 5 yrs from baseline]
PROFFIT score and survival [Срок оценки: baseline, at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires, then every 6 months during endocrine therapy/other treatments/follow-up until 5 yrs from baseline]
Quality of Life (EORTC QLQ-C30, EORTC-BR42) [Срок оценки: baseline, at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires, then every 6 months during endocrine therapy/other treatments/follow-up until 5 yrs from baseline]

Критерии участия

Критерии включения

Signed informed consent form
Age > 18 years at the time of study entry
Histologically confirmed stage I-III invasive breast carcinoma before starting any systemic treatment.