Меню
Идёт набор NCT07124611

A Brief Psychological Intervention to Improve Emotional Well-Being During Neoadjuvant Therapy for Pancreatic Cancer

Без фазы С лечением Localized Pancreatic Ductal Adenocarcinoma Stage 0 Pancreatic Cancer AJCC v8 Stage I Pancreatic Cancer AJCC v8 Stage IIA Pancreatic Cancer AJCC v8

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: Interview, Nutritional Therapy, Physical Therapy, Psychosocial Care.
Кому может быть актуально
Состояния в реестре: Localized Pancreatic Ductal Adenocarcinoma, Stage 0 Pancreatic Cancer AJCC v8, Stage I Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8. 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Testing the Feasibility of Incorporating Psychosocial Oncology During Neoadjuvant Therapy for Patients With Pancreatic Cancer

Обзор

This clinical trial tests how well a psychosocial oncology intervention during neoadjuvant therapy works for patients with pancreatic cancer that has not spread to other parts of the body (localized). Chemotherapy and/or radiation therapy is often recommended prior to surgeryf or patients with pancreatic cancer; this is known as neoadjuvant therapy (NT). The primary advantages of NT include: reducing the size of the cancer mass and/or reducing the spread of cancer, to improve the likelihood of getting all the cancer during surgery, and because receiving chemotherapy after pancreas surgery can be challenging. Other research has shown that NT can lead to improved survival and a lower rate of the cancer returning. Despite these positive effects, NT can be associated with significant physical and emotional side effects. To prepare patients for future surgery and maintain health during chemotherapy and/or radiation, prehabilitation is often recommended. This can include nutritional and physical therapy to help with physical health. An oncology (cancer) psychosocial intervention during NT may be feasible and helpful to patients with localized pancreatic cancer.

Подробное описание

PRIMARY OBJECTIVES:

I. To test the feasibility and acceptability of incorporating a psychosocial oncology intervention for patients with pancreatic cancer undergoing neoadjuvant therapy prior to surgical resection.

II. To measure the preliminary efficacy of psychosocial oncology on quality of life and stress/anxiety.

OUTLINE:

Patients participate in a psychosocial oncology intervention consisting of meeting with a psychologist via telehealth sessions over 40 minutes once a week for 4 weeks on study. Patients also receive standard physical therapy and nutritional therapy referrals.

Вмешательства

  • Другое Interview
    Ancillary studies
  • Процедура Nutritional Therapy
    Attend nutritional appointments
  • Процедура Physical Therapy
    Attend physical therapy appointments
  • Поведенческое Psychosocial Care
    Receive psychosocial care
  • Другое Questionnaire Administration
    Ancillary studies

Первичные конечные точки

  • Feasibility and acceptability of the psychosocial oncology intervention [Срок оценки: Up to 1 year]
Вторичные конечные точки (4)
  • Changes in health-related quality of life for patients with hepatobiliary cancer [Срок оценки: Up to 1 year]
  • Changes in mood for patients with hepatobiliary cancer [Срок оценки: Up to 1 year]
  • Changes in worry for patients with hepatobiliary cancer [Срок оценки: Up to 1 year]
  • Changes in uncertainty for patients with hepatobiliary cancer [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

  • Adults ≥ 18 years of age
  • Patient:
  • Newly diagnosed patients with localized pancreatic ductal adenocarcinoma (PDAC) presenting to Ohio State University Wexner Medical Center-Comprehensive Cancer Center (OSUMC-CCC)
  • Plans to initiate neoadjuvant therapy prior to surgical resection
  • Neoadjuvant therapy (NT) and/or surgery may occur at another facility

Критерии исключения

  • Prisoners
  • Persons unable to provide consent
  • Patients unlikely to undergo surgical resection following NT based on anatomical or performance status considerations
  • Confirmed or presumed metastatic disease
  • Already received ≥ 2 cycles of chemotherapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Ohio State University Comprehensive Cancer Center — Columbus

Идентификаторы

NCT: NCT07124611 · OSU-24234 · NCI-2025-05461

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗