SupporTive Care At Home Research for Patients With Advanced Cancer (STAHR-cancer)

Официальное название

SupporTive Care At Home Research (STAHR): a Cluster Non-randomized Controlled Trial for Patients With Advanced Cancer

Обзор

To test the effects of home-based care on unplanned hospitalization within 6 months among advanced cancer patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-ups.

Подробное описание

This study is a cluster, non-randomized controlled trial to test the effects of home-based care on unplanned hospitalization in 6 months among advanced cancer patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-up. We are recruiting the study participants from 6 institutions, aiming for 396 cancer patients.

Participants for the intervention group will be recruited from Seoul National University Hospital, Chung-ang University Hospital, and Dongguk University Ilsan Hospital. Participants for the control group will be recruited from Kyung Hee University Medical Center, CHA Bundang Medical Center, and Seoul National University Bundang Hospital.

Вмешательства

• Другое Home-based care
  Home-based medical care is based on a specialized home-based medical team approach, including following: 1. Specialized Home-Based Medical Team Approach 2. Initial Assessment and Education 3. Initial Home Visits and Education 4. Multidisciplinary Team Meeting 5. Regular Assessment After the Initial Visit

Первичные конечные точки

• Unplanned hospitalization [Срок оценки: within 6 months following enrollment]

Вторичные конечные точки (12)

• Patient medical utilization [Срок оценки: within 6 months following enrollment]
• Hospitalization [Срок оценки: within 6 months following enrollment]
• ER visits [Срок оценки: within 6 months following enrollment]
• Healthcare use [Срок оценки: within 6 months following enrollment]
• Patient end-of-life care: ICU admission [Срок оценки: within 1 month before death]
• Patient end-of-life care: ventilator treatment [Срок оценки: within 1 month before death]
• Patient end-of-life care: an advance directive [Срок оценки: within 1 month before death]
• Quality of life of patient - ESAS [Срок оценки: within 6 months following enrollment]
• Quality of life of patient - EQ-5D [Срок оценки: within 6 months following enrollment]
• Depressive symptom of patient [Срок оценки: within 6 months following enrollment]
• Satisfaction with services (patient) [Срок оценки: within 6 months following enrollment]
• Quality of life of family caregiver [Срок оценки: within 6 months following enrollment]

Критерии участия

Критерии включения

Both the patient and their family caregiver must meet the criteria to be considered for this research.

• Patient

• A person who has an advanced-stage solid cancer diagnosis (ICD-10 code C00-C70); A person who is receiving or planning to receive cancer treatment
• A person who meets one of the following conditions

• Has been evaluated as having ECOG performance status 2
• Has been evaluated as having ECOG performance status 1 and is over 70 years of age
• A person who wishes to stay at home
• A person whose family caregiver resides at home
• A person who wishes to participate in the research
• Family Caregiver

• A family\* member of the patient

\* Family: refers to the patient's spouse (including a common-law partner), descendants and their spouses up to the second degree, siblings and their spouses, and relatives and their spouses up to the eighth degree.

• A person who meets one of the following conditions:

• Lives with the patient (patient's household member)
• Does not live with the patient, but visits the patient's home more than three times a week
• A person who wants the patient to stay at home
• A person who can communicate easily with medical staff
• A person who wishes to participate in the research

Критерии исключения

If either the patient or the family caregiver meets any one of these criteria, they are excluded from the study.

• Patient

• A person who cannot speak, hear, or read Korean
• A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health
• A person residing outside the range that can be visited by the respective medical institution (the conditions for distance are to be specified by each medical institution)\*

\* This condition is not applicable for the control group.

• A person who has used hospital- or home-type hospice and palliative care services
• A person who is under the age of 19
• Family Caregiver

• A person who cannot speak, hear, or read Korean
• A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health
• A person under the age of 19

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

South Korea · 6 центров

• Dongguk University Medical Center — Goyang-si
• Bundang CHA Hospital — Seongnam-si
• Seoul National University Bundang Hospital — Seongnam-si
• Seoul National University Hospital — Seoul
• Chung-Ang University Hosptial — Seoul
• Kyung Hee University Hospital — Seoul

Идентификаторы

NCT: NCT05636384 · HC21C0115-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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