NCT04611867

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 274 (estimated)
• Sponsor: Inna Chen, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer
• Lung Cancer, Nonsmall Cell

Interventions

Type	Name	Description
OTHER	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 or refers to (if possible) treating physician if patient will require medical intervention and/or physician assistance.

Timeline

• Start date: 2021-08-17
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2020-11-02
• Last updated: 2024-10-02

Locations

1 site across 1 country: Denmark