Study of PRO in Patients with Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay)

Официальное название

Study of Supportive Application with Integrated Patient-Reported Outcomes in Patients with Advanced Pancreatic or BiliaryTract Cancer (BetterEveryDay)

Обзор

Pancreatic and biliary tract cancer are ones of the leading causes of cancer-related deaths. During the course of illness, these patients often experience marked physical suffering, psychological distress and frequent unplanned resource-demanding hospitalized care. Patients with pancreatic and lung cancer have highest rates of unplanned hospitalizations. Investigator initiated prospective "Study of Supportive Application with Integrated Patient-Reported Outcomes in Patients with Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay)" is to be initiated based on the great need for optimizing treatment care, reducing hospitalizations and improving outcomes.

Подробное описание

The trial is designed as an investigator initiated prospective study of patients with advanced pancreatic or biliary tract cancer initiating systemic treatment to determine the feasibility and efficacy of supportive application with integrated weekly Patient-Reported Outcomes (PRO) on unplanned hospitalization, Quality of Life (QoL), survival, satisfaction with oncologist communication, and resource utilization.

This study will consist of Part A (Feasibility), as well as a possible Part B (Randomized controlled trial, RCT).

Initially, 30 patients with advanced lung (NSCLC) and pancreatic cancer initiating systemic therapy will be enrolled in the Part A to assess the feasibility of the supportive application with integrated weekly PRO. Patients included in feasibility Part A will be instructed in self-reporting via web-based supportive application with integrated weekly PRO.

In case of successfully completed Part A, the randomized Part B will be activated to determine the efficacy of the supportive application with integrated weekly PRO on unplanned hospitalization, QoL, survival, satisfaction and resource utilization for patients with advanced lung (NSCLC) and pancreatic cancer initiating systemic therapy. Format of that Part B will be adjusted if indicated based on the feasibility responses seen in the 30 patients in Part A. Patients will be randomized in Part B with a 1:1 ratio in a stratified manner according to cancer type (biliary tract cancer versus pancreatic cancer). If initiated, the data from Part B: RCT will be analyzed separately and will not be pooled with Part A for the purpose of statistical analysis.

Over the course of the study patients in both arms will be asked to complete questionnaires about QoL at baseline and week 12 and 24. Additionally, patients in both arms are asked to complete the modified Health Care Climate Questionnaire (HCCQ) at week 12 and 24.

Вмешательства

• Другое Supportive application with integrated weekly PRO
  Patients will fill in a web-based application PRO-CTCAE with integrated preparation questionnaire every week. If their weekly reported symptoms exceed a predefined threshold of severity, this results in a notification on the staff application interface and a nurse will contact a patient for verification of symptoms. Nurse will review patient recent treatment and PRO reports and advise patient according to the local practice for symptom management and reinforce reporting. Nurse will consult with

Первичные конечные точки

• Feasibility (Part A) [Срок оценки: 3 months]
• Hospitalization (Part B) [Срок оценки: 6 months]

Вторичные конечные точки (4)

• EORTC QLQ-C30 global health status/QoL scale [Срок оценки: 6 months]
• EORTC QLQ-C30 functional scales and symptom scales/items [Срок оценки: 6 months]
• Overall survival [Срок оценки: 1 year]
• Satisfaction with oncologist communication at 12 and 24 weeks as measured by the modified Health Care Climate Questionnaire (HCCQ) [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Adult (aged 18 and over)
• Confirmed by cytology or histology advanced lung (NSCLC) or pancreatic cancer
• Written informed consent before any study procedures
• Planning to receive 1st line systemic anticancer therapy within ≤2 weeks
• Performance status: ECOG 0-2
• Access to the internet
• Ability to read and respond to questions or able to complete questions with minimal assistance required from an interpreter or family member

Критерии исключения

• No mobile device
• Exhibiting signs of overt psychopathology or cognitive dysfunction
• Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of study assessments
• Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention. Participation in protocols related only to treatment will not preclude participation in the present study. Cases of doubt will be settled by the protocol responsible.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Дания · 1 центр

• Herlev & Gentofte University Hospital, Denmark — Herlev

Идентификаторы

NCT: NCT04611867 · AA2058

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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