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Набор скоро начнётся NCT07671586

Enhancing Patient Experience in Geriatric Oncology

Без фазы С лечением Confort Older Adults With 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: Comfort menu and cart implemented.
Кому может быть актуально
Состояния в реестре: Confort, Older Adults With Cancer. Базовые параметры: от 60 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
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Enhancing the Experience of Older Adults With Cancer Through a Comfort Menu and Cart for: Protocol of a Quasi-experimental, Before-and-after Study in a Tertiary Oncology Center

Обзор

Approximately 60% of new cancer diagnoses and 70% of cancer-related deaths occur in adults aged 65 years and older, a population frequently affected by multimorbidity, frailty, sensory impairment, and treatment-related symptom burden. Outpatient oncology centers, although designed for efficient antineoplastic therapy delivery, are rarely adapted to the specific needs of older adults, and pragmatic, low-cost interventions to enhance patient experience and the clinical care journey remain scarce. The "comfort menu and cart," a non-pharmacological strategy initially developed for the emergency department, has shown promising effects on patient and staff experience, but has not been evaluated in the geriatric oncology setting. Methods: This protocol describes a quasi-experimental, before-and-after, single-center study evaluating the implementation of a comfort menu and cart at the Oncology Center of Hospital Sírio-Libanês, a tertiary philanthropic hospital in São Paulo, Brazil. Patients aged 65 years and older receiving intravenous chemotherapy, supportive therapy, or evaluation of intercurrent symptoms during oncological treatment will be recruited over 12 months: six months pre-intervention and six months post-intervention, with 132 participants per phase and a total sample of 264 participants. All participants will undergo a comprehensive geriatric assessment, including G8, Charlson Comorbidity Index, Clinical Frailty Scale, Geriatric Depression Scale - 15-item version, Katz Index of Independence in Activities of Daily Living, Barthel Index of Activities of Daily Living, Lawton-Brody Instrumental Activities of Daily Living Scale, 10-point Cognitive Screener, and EuroQol 5-Dimension questionnaire. This assessment will be complemented by oncology-specific patient-reported outcomes, including the Edmonton Symptom Assessment System, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information 25, and a structured adherence questionnaire. Caregiver anxiety, depression, and burden will be assessed using the Hospital Anxiety and Depression Scale and the Zarit Burden Interview short version. The primary outcome will be patient experience, measured using Likert-scale instruments adapted from previously published comfort care and emergency department experience instruments. Secondary outcomes include staff experience, length of stay, satisfaction indicators, oncological treatment adherence, symptom control, patient understanding of disease-related information, functionality, need for re-evaluation, hospital admissions, and caregiver outcomes at 30 days. Expected Results: The study is expected to demonstrate that a low-cost, non-pharmacological intervention can enhance the experience of older adults with cancer and multidisciplinary teams, with favorable effects on symptom control, information comprehension, treatment adherence, and 30-day clinical outcomes.

Вмешательства

  • Другое Comfort menu and cart implemented
    The comfort menu and cart will be implemented after the pre-intervention data collection phase.The cart will be positioned in an easily accessible area of the infusion floor, and the menu will be presented to eligible patients in printed or digital format (tablet). A one-month rollout period will precede post-intervention enrolment, dedicated to staff training and resolution of logistic challenges, in order to optimize fidelity. Comfort cart contents: Hot and cold packs; Extra blankets and pill

Первичные конечные точки

  • Experience of older patients treated in the tertiary oncology center [Срок оценки: Baseline assessment during oncologic center stay]
Вторичные конечные точки (5)
  • Experience of medical and multidisciplinary staff involved in caring for older patients treated in the oncologic Center [Срок оценки: 6 months pre and post intervention, cuncurrent with patients inclusion]
  • Transactional Net Promoter Score [Срок оценки: 30 days]
  • Number of Ombudsman Manifestations Classified by Type [Срок оценки: 30 days]
  • Caregiver anxiety and depression symptoms [Срок оценки: Baselina assessment during Oncologic Center stay]
  • Caregiver burden [Срок оценки: Baseline assessement using oncologic center stay]

Критерии участия

Критерии включения

  • Age 60 years or older.
  • Receiving care at the Oncology Center in the context of active cancer treatment: intravenous chemotherapy, supportive therapy, or clinical evaluation.
  • Capacity to provide informed consent and respond to the interview, or presence of a legal representative or companion able to do so.

Exclusion criteria.

  • Refusal to participate in the study or to use the comfort menu and cart items.
  • Decreased level of consciousness or acute clinical instability (hemodynamic instability, acute respiratory failure).
  • Absence of a companion able to consent and provide information when the patient presents cognitive impairment.
  • Inability to be contacted by telephone for the follow-up interview.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

Бразилия · 1 центр
  • Hospital Sírio Libanês — São Paulo

Идентификаторы

NCT: NCT07671586 · AVAP-NG 3776-B

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗