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

NCT04611867 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2024-10-02

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Inna Chen, MD

    lead OTHER

Principal Investigators

  • Inna M Chen, MD · Herlev and Gentofte Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2026-04-01
Completion
2027-04-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04611867 on ClinicalTrials.gov