RecruitingNot ApplicableNCT04611867

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)

Sponsor

Inna Chen, MD

Enrollment

274 participants

Start Date

Aug 17, 2021

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Lung Cancer, Nonsmall Cell

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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

Exclusion Criteria4

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.

Interventions

OTHERSupportive 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.