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Идёт набор NCT06461780

Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy

— Наблюдательное Cancer Immunotherapy IrAE Distress, Emotional

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: Cancer, Immunotherapy, IrAE, Distress, Emotional. 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
Тайвань
Следующий шаг
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Официальное название

Exploring Physical and Psychological Distress, Financial Toxicity, Care Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy in One Year Follow-up: Psychometric Testing and Developing Prediction Models for Immune-related Adverse Events

Обзор

During the immune checkpoint inhibitor therapy (ICIT), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of life. Therefore, the aims of this program are to (1) explore the immune-related adverse event (irAE) severity, distress, financial toxicity, and quality of life and examine the psychometric testing of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM); (2) establish the LINE group for assessing irAE severity and change trajectory of quality of life in one-year follow-up and (3) combined retrospective chart review and the finding in aim (2) to develop the risk prediction model in order to identify the high risk population.

Подробное описание

To achieve aim 1, a cross-sectional design is conducted to explore irAE severity, distress, financial distress, and quality of life in mixed type of cancer patients receiving ICIT. A structural questionnaire will be used including Common Terminology Criteria for adverse events (CTCAE) 33 items, Distress Thermometer (DT), the Comprehensive Score for financial Toxicity (COST), FACT-ICM, and EORTC-QLQ C30. Correlation analysis and exploratory factor analysis will be used to examine the psychometric testing of FACT-ICM.

To achieve aim 2 and 3, a prospective cohort study will be conducted to recruit 200 patients in first course receiving ICIT and follow for 1 year using LINE to report symptoms in weekly reporting within 3 months and once in 3-4 weeks in 4th -12th months during treatment. Data will be collected at five times (Before treatment for baseline, the 3th, 6th 9th 12th months) using a set of questionnaires including CTCAE 33 items, DT, COST, Supportive Care Needs Scale-short form34, and FACT-ICM.

Первичные конечные точки

  • Patient-Report Outcome-- Common Terminology Criteria for adverse events (PRO-CTCAE) [Срок оценки: The data will be collected once a week within 3 months and once in 3-4 weeks in 4th-12th months during treatment.]
  • Symptom Severity Scale (SSS) [Срок оценки: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
  • Distress Thermometer (DT) [Срок оценки: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
  • The COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) [Срок оценки: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
  • The Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) [Срок оценки: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
  • European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30) [Срок оценки: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
  • Supportive Care Needs Survey-Short Form 34 (SCNS-SF34) [Срок оценки: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]

Критерии участия

Критерии включения

  • (1) Patients diagnose cancer and are informed
  • (2) Aged ≥18 years old
  • (3) Conscious clear and able to communicate

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Тайвань · 1 центр
  • Taipei Veterans General Hospital — Taipei

Идентификаторы

NCT: NCT06461780 · 2023-03-005BC · NSTC 114-2314-B-A49 -008 - · NSTC 113-2314-B-A49 -013 - · NSTC 112-2314-B-A49 -077 -

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗