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Идёт набор NCT05663203

A Web-Based Dyadic Intervention for Colorectal Cancer

Без фазы С лечением Colorectal Carcinoma

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: Internet-Based Intervention, Interview, Survey Administration, Electronic Health Record Review.
Кому может быть актуально
Состояния в реестре: Colorectal Carcinoma. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Web-Based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients With Colorectal Cancer and Their Caregivers

Обзор

This clinical trial studies how well a web-based dyadic intervention works to manage psychoneurological symptoms for patients with colorectal cancer and their caregivers. Patients with colorectal cancer receiving chemotherapy experience severe and distressing psychoneurological symptoms that include fatigue, depression, sleep disturbance, pain, and cognitive dysfunction. When these co-occurring symptoms are undertreated, they negatively affect functional status, survival rates, and quality of life of patients as well as decrease health outcomes of their family caregiver. A critical need exists to develop an effective and novel intervention that focuses on patients with colorectal cancer receiving chemotherapy and their caregivers. A web-based dyadic intervention holds great promise to reduce psychoneurological symptoms burden and improve quality of life for patients with colorectal cancer receiving chemotherapy and advance intervention development and implementation in cancer supportive care and health equity.

Подробное описание

PRIMARY OBJECTIVES:

I. To develop a web-based dyadic intervention for patients with colorectal cancer receiving chemotherapy and their caregivers (CRCweb).

Ia. Determine tailored contents by identifying needs and supports for a web-based dyadic intervention using interviews with patient-caregiver dyads (n=8); Ib. Develop a prototype of a web-based dyadic intervention program (CRCweb); Ic. Test the usability (e.g., design, navigation, structure, language) of CRCweb prototype using interviews with 4 dyads (in Aim Ia).

II. Evaluate the feasibility and acceptability of CRCweb for patients with colorectal cancer receiving chemotherapy and their caregivers in 20 dyads in a pilot clinical trial.

III. Evaluate the preliminary effects of CRCweb on the primary outcome (i.e., attrition, adherence, acceptability, fatigue, depression, sleep disturbance, pain, and cognitive dysfunction) and secondary outcomes (i.e., quality of life) for patients with colorectal cancer receiving chemotherapy and their caregivers in 20 dyads in a pilot clinical trial.

OUTLINE:

Patients and caregivers attend a CRCweb intervention over 8 weeks. Patients and caregivers complete interviews and surveys throughout the trial.

Вмешательства

  • Другое Internet-Based Intervention
    Attend CRCWeb intervention
  • Другое Interview
    Complete interview
  • Другое Survey Administration
    Complete survey
  • Другое Electronic Health Record Review
    Medical records are reviewed

Первичные конечные точки

  • Attrition Rate [Срок оценки: Up to week 8]
  • Adherence Rate [Срок оценки: Up to week 8]
  • Acceptability Rate [Срок оценки: Up to week 8]
  • Multidimensional Fatigue Inventory [Срок оценки: Up to week 8]
  • Patient Health Questionnaire [Срок оценки: Up to week 8]
  • Pittsburgh Sleep Quality Index [Срок оценки: Up to week 8]
  • Brief Pain Inventory [Срок оценки: Up to week 8]
  • Attentional Function Index [Срок оценки: Up to week 8]
Вторичные конечные точки (1)
  • Short Form Health Survey [Срок оценки: Up to week 8]

Критерии участия

Критерии включения

Patients:

  • Age >= 18 years
  • Diagnosed with colorectal cancer
  • Life expectancy > 12 months
  • Receiving active chemotherapy
  • Self-reported at least two psychoneurological symptoms (based on the symptom measures' cutoff scores)
  • Identified primary caregiver (i.e., family members or significant others identified by the patients as their primary source of emotional and physical support)
  • Access to the Internet
  • Fluent in English

Caregivers:

  • Age >= 18 years
  • Primary caregiver
  • Access to the Internet
  • Fluent in English

Критерии исключения

Patients:

  • Karnofsky Performance Scale < 50

Caregivers:

  • Have severe diseases (e.g., cancer, heart disease)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Emory University/Winship Cancer Institute — Atlanta

Публикации

  • Lin Y, Porter LS, Chee W, Alese OB, Curseen KA, Higgins MK, Northouse L, Xiao C. A Web-Based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients With Colorectal Cancer and Their Caregivers: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2023 Jun 28;12:e48499. doi: 10.2196/48499. PMID 37379055

Идентификаторы

NCT: NCT05663203 · STUDY00004750 · EU5733-22 · 2022RE03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗