Идёт набор NCT03265379

Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection

— 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: FACT-B and Brief Pain Inventory.
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: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Although chest wall recurrence of breast cancer is uncommon, it represents a difficult clinical scenario. The role of full thickness chest wall resection (FTCWR) for breast cancer recurrence in the chest wall is controversial and is complicated by the fact that no prospective evidence exists evaluating the utility of FTCWR in prolonging survival or improving health related quality of life (HRQOL) and thus, there is a lack of evidence to guide treatment decisions. Gathering HRQOL, local-regional recurrence (LRR) and survival data in a prospective fashion is thus critical in this population. Therefore, we designed a prospective trial to evaluate the outcomes for FTCWR in terms of LRC and HRQOL, and short-term morbidity and mortality, with secondary focus on potential long-term overall survival benefit.

Подробное описание

This study is a prospective, non-randomized cohort study for patients with chest wall-recurrent/invasive breast cancer treated with full thickness chest wall resection (FTCWR), chemotherapy and/or radiation. The design of this study was created using the framework for surgical trials set out by the IDEAL collaboration (Idea, Development, Exploration, Assessment, Long-Term follow up), 14 after a systematic evaluation of the current literature had been completed. Given that no prospective evidence exists in this patient population and based on the IDEAL framework, this study is designed to create a prospective registry.

Data on the efficacy of the standard interventions (surgery, chemotherapy, radiation) will be evaluated using 'global criteria', that is, the data that will be collected via the scores on the FACT-B, the Brief Pain Inventory, and the specific cancer outcomes as outlined previously (local regional recurrence (LRC), overall survival, short term morbidity and mortality as well as disease-free survival).

The primary objective is to measure the differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores from baseline to 6 month evaluation.

In addition to measuring health related quality of life (HRQOL) at 6 months, differences in the FACT-B scale at 1-month, 3-months and 1-year postoperatively will be examined. Rates of LRC, defined as local recurrence in the ipsilateral chest wall, axilla, infra- or supraclavicular region at 1, 2, 3 and 5-years postoperatively will be measured, as well as thirty and ninety-day morbidity and mortality (to be classified using the Thoracic Morbidity and Mortality (TM and M) classification system). As well, data will be collected on overall survival, measured as the proportion of patients surviving to at 1-year, 2-years, 3-years and 5 years postoperatively. Lastly, data will be collected on disease-free survival, defined as any evidence of systemic recurrence plus LRR at 1-year, 2-years, 3-years and 5-years postoperatively.

Вмешательства

Другое FACT-B and Brief Pain Inventory
Quality of Life Questionnaires

Первичные конечные точки

differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores [Срок оценки: from baseline to 6 month evaluation]

Вторичные конечные точки (6)

FACT-B scale [Срок оценки: 1-month, 3-months and 1-year postoperatively]
Local Recurrence [Срок оценки: 1, 2, 3 and 5-years postoperatively]
Morbidity and mortality [Срок оценки: 90 days post op]
Overall Survival [Срок оценки: 1-year, 2-years, 3-years and 5 years postoperatively]
Disease Free Survival [Срок оценки: 1-year, 2-years, 3-years and 5 years postoperatively]
Brief Pain Inventory [Срок оценки: 1 month, 3 months, 6 months and 1 year postoperatively.]

Критерии участия

Критерии включения

>18 years of age
Breast cancer with invasion of the chest wall (ribs, para-costal soft tissue, intercostal muscle or soft-tissue) that is:

Radiologically proven on cross-sectional imaging
Histologically proven
Medically fit for surgery
>1 year disease-free interval (between initial treatment and recurrence) for patients with local recurrence