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Идёт набор NCT07357311

Screening and Care for Fear of Cancer Recurrence in Patients With Cancer at Institut Curie

Наблюдательное Lung Cancer 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Lung Cancer, 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Fear of Cancer Recurrence: Prevalence, Lived Experience and Satisfaction of Supportive Care Needs in the Hospital Care Pathway. A Mixed Method Study.

Обзор

The goals of this study is to establish the prevalence of severe forms of FCR in the oncology hospital setting, which will require a specific psychotherapeutic response. Two cancer sites are targeted: breast and pulmonary cancers. Secondary objectives include: 1) Determining threshold scores for the FCRI's 9-item severity scale for each type of cancer; 3) To identify a simple item from the FCRI for early detection of FCR in everyday clinical practice, especially using a digital format.

Подробное описание

Context and scientific background Fear of cancer recurrence (FCR) is a common concern among cancer patients. It has a significant impact on patients' quality of life and can lead to inappropriate health behaviours, which can hinder treatment management and patient survival. A Delphi survey identified the steps needed to pursue research in the field of FCR, in particular understanding its manifestations in specific populations. It also involves perfecting and culturally validating screening tools for FCR to ensure accurate detection and equitable access to appropriate care when needed. The Fear of Recurrence Inventory (FCRI) is, to date, the most widely validated tool for measuring FCR. However, its clinical use is limited due to its length and the absence of established cut-off scores, particularly for French-speaking populations.

Progresses in oncology mean that patients with advanced cancer can live longer. They differ from patients in remission and from terminally ill patients with an estimated life expectancy of less than a year. Therefore, their fears do not concern recurrence, but rather the progression of the disease. Their psychological state also differs from the concerns of end-of-life patients. Fear of progression is included in the definition of FCR (i.e. 'fear of worry that the cancer will return or progress. Yet fear of recurrence is seldom studied in patients with metastatic cancer. The aim is therefore to explore the specific features of the metastatic stage of the disease compared with the non-metastatic stage.

Methodology / Questionnaires / Hypothesis This is a mixed-method study. 200 patients will be identified consecutively, three months after a breast or lung cancer treatment completion or three months after the start of a first line of treatment for a metastatic progression. Both these cancer types have been selected in order to ensure recruitment feasibility in this study, as they are the most frequently treated at the Institut Curie. Study will include 100 patients per cancer type. Semi-structured clinical interviews will be conducted with these patients after they have completed the FCRI. These interviews' analyses will enable us to classify patients according to their FCR levels. Based on this classification, threshold scores for high FCR will be assessed for their sensitivity and specificity for both the 9-item scale and a single item. More in-depths qualitative interviews will be carried out with a random sample of 40 of these patients, stratified by cancer type and stage, in order to explore their perceptions of the disease, the risk of recurrence, their cognitive, emotional and behavioural responses to this risk, and their internal and external psychological resources. Satisfaction will also be assessed with the psychological resources currently available to cope with FCR.

Первичные конечные точки

  • Proportion of patients scoring above a cut-off on the 9-item Fear of cancer recurrence inventory (FRCI) severity scale [Срок оценки: Within 1 month after inclusion]
Вторичные конечные точки (1)
  • Emergent themes related to perceptions of cancer, fear of recurrence, psychological responses, and satisfaction with support resources. [Срок оценки: Within 1 month after inclusion]

Критерии участия

Критерии включения

  • Aged 18 or over
  • Clinical or pathological diagnosis of primary or recurrence of a localized/loco-regional or metastatic breast cancer, or a stage 1 or 2, or stage 3 or 4 lung cancer; or a breast or lung cancer metastatic progression
  • Three months after completing treatment or three months after the start of a first treatment line for metastatic progression
  • Able to comply with the scheduled assessment and interviews
  • Able to read and understand the questionnaires' language (i.e. French)

Критерии исключения

  • Participating in another patient-reported outcome study interfering with the present study
  • Any social, medical or psychological condition hindering questionnaire completion
  • Being deprived of personal liberty or under guardianship

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Institut Curie — Paris

Идентификаторы

NCT: NCT07357311 · IC 2025-08

Первоисточники (государственные реестры)

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