Assessment and Prevention of Caregiver Burden in Oncology

Обзор

The goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life. Participants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month. Researchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support. The specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.

Вмешательства

• Другое Specific nursing support
  * 3 mandatory on-site nursing consultations with the patient's caregiver at inclusion, 6 months and 12 months post-randomisation.The caregivers will complete the questionnaires (Zarit scale, Hospital Anxiety and Depression scale, Medical Outcome Study Short Form - 36, Caregiver's satisfaction). * interviews once a month with a nurse either by phone, on-site consultation or teleconsultation. Nurses assess the general health of the caregiver and Identify the socio-professional situation of the ca
• Другое Non-specific nursing support
  Caregivers will only have to complete on site Health indicators, Zarit scale, Hospital Anxiety and Depression scale, Medical Outcome Study Short Form - 36 at inclusion, 6 months and 12 months post-randomisation.

Первичные конечные точки

• Caregiver burden [Срок оценки: at 6 months post-randomisation]

Вторичные конечные точки (3)

• The level of anxiety/depression of the caregiver [Срок оценки: at month 6 (M6) and month 12 (M12) post-randomisation.]
• Caregiver's quality of life [Срок оценки: at month 6 (M6) and month 12 (M12) post-randomisation.]
• Caregiver's satisfaction [Срок оценки: at month 6 (M6) and month 12 (M12) post-randomisation.]

Критерии участия

Критерии включения

• Caregiver designated by the patient;
• Caregiver of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month;
• Caregiver of patient already cared for by a nurse before inclusion or going to start a nursing follow-up;
• Caregiver of a patient with a score ≥2 of social fragility and/or psychological fragility and/or nutritional fragility and/or complexity;

Критерии исключения

• Patient whose life expectancy is assumed to be < 6 months;
• Patient living in an institution (EHPAD, MAS, SSR, MCO, USLD) at inclusion;
• Caregiver declared as having a pathology that could alter his/her capacity to support (psychiatric history, dementia…) or under guardianship.

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 5 центров

• CH Cholet — Cholet
• Centre Antoine Lacassagne — Nice
• Centre Henri Bequerel — Rouen
• Institut de Cancérologie de l'Ouest — Saint-Herblain
• CH Mémorial de Saint Lo — Saint-Lô

Идентификаторы

NCT: NCT05750836 · ICO-2022-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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