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Идёт набор NCT06524973

Telehealth Self-Management Coaching Sessions to Improve Quality of Life in Pancreatic Cancer Survivors and Their Family Care Givers

Без фазы С лечением Metastatic Pancreatic Adenocarcinoma

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: Telemedicine, Counseling, Best Practice, Questionnaire Administration.
Кому может быть актуально
Состояния в реестре: Metastatic Pancreatic Adenocarcinoma. 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

Impacting Quality of Life and Pancreatic Cancer Survivorship Through a Telehealth Intervention

Обзор

This clinical trial evaluates the impact of telehealth self-management coaching sessions on quality of life in pancreatic cancer survivors and their family care givers (FCGs). Patients with pancreatic cancer experience many symptoms because of the disease and treatment, which can have a negative impact on quality of life. Patients and their families have unmet needs during treatment, including a lack of quality of life programs that offer support to patients. Supporting patients and families on managing the physical symptoms, emotional well-being, social well-being and spiritual well-being with telehealth self-management coaching sessions may help improve quality of life, manage symptoms from treatment, and support families in their role as caregivers during treatment.

Вмешательства

  • Другое Telemedicine
    Attend telehealth self-management coaching sessions
  • Другое Counseling
    Attend telehealth self-management coaching sessions
  • Другое Best Practice
    Receive standard of care
  • Другое Questionnaire Administration
    Ancillary studies
  • Другое Inrweview
    Ancillary studies

Первичные конечные точки

  • Patient reported quality of life (QOL) [Срок оценки: At baseline and at 3 months post randomization]
Вторичные конечные точки (10)
  • Enrollment rate [Срок оценки: Up to 25 months]
  • Intervention completion rate [Срок оценки: Up to 6 months]
  • Rate of participants completing any follow-up assessments [Срок оценки: Up to 6 months]
  • Participant experience [Срок оценки: Up to 6 months]
  • Patient reported symptom severity [Срок оценки: At baseline and at 3 and 6 months post randomization]
  • Patient reported psychological distress [Срок оценки: At baseline and at 3 and 6 months post randomization]
  • Family care giver (FCG) psychological distress [Срок оценки: At baseline and at 3 and 6 months post randomization]
  • FCG caregiving burden [Срок оценки: At baseline and at 3 and 6 months post randomization]
  • FCG QOL [Срок оценки: At baseline and at 3 and 6 months post randomization]
  • Overall survival [Срок оценки: From initiation of intervention to death from any cause, up to 6 months]

Критерии участия

Критерии включения

  • • PATIENT: Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines
  • PATIENT: Age: ≥ 18 years
  • PATIENT: Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • PATIENT: Ability to read and understand English or Spanish for questionnaires
  • PATIENT: Subjects must have histologically or cytologically confirmed diagnosis of metastatic pancreatic adenocarcinoma who are within 8 weeks of initial diagnosis
  • FAMILY CARE GIVER: Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines
  • FAMILY CARE GIVER: Age: ≥ 18 years
  • FAMILY CARE GIVER: Ability to read and understand English or Spanish for questionnaires
  • FAMILY CARE GIVER: A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care

Критерии исключения

  • • An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager
  • A direct study team member

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 22 центра
  • City of Hope at Arcadia — Arcadia
  • City of Hope Corona — Corona
  • City of Hope at Duarte — Duarte
  • City of Hope Comprehensive Cancer Center — Duarte
  • City of Hope at Glendale — Glendale
  • City of Hope at Glendora — Glendora
  • City of Hope Seacliff — Huntington Beach
  • City of Hope at Irvine Lennar — Irvine
  • … и ещё 14 центров

Идентификаторы

NCT: NCT06524973 · 24172 · NCI-2024-06078

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗