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

NCT ID: NCT04611867

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-17
• Study Completion Date: 2027-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Arm

The intervention will be comprised of providing patients with supportive application with integrated PRO consisting of:

• Weekly self-reporting of PRO-CTCAE with integrated preparation questionnaire available for staff
• Daily monitoring of self-reporting by study staff
• Intervention if required based on self-reporting
• Reports to oncologists (at consultation)
• Information module about treatment, side effects and contact information

Group Type: EXPERIMENTAL

Supportive application with integrated weekly PRO

Intervention Type: OTHER

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.

Standard Arm

Standard care for patients will be included in no-intervention arm will consist of the standard procedures at Herlev Hospital, Department of Oncology for monitoring and documenting symptoms, which will be typical of oncology practice. Symptoms will be discussed and documented in the medical record during clinical encounters between patients and their oncologists. Patients will be encouraged to initiate telephone contact between visits for concerning symptoms, i.e. "call early and often".

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Inna Chen, MD

OTHER

Sponsor Role: lead

Responsible Party

Inna Chen, MD

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Inna M Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev and Gentofte Hospital

Locations

Herlev & Gentofte University Hospital, Denmark

Herlev, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Inna M Chen, MD

Role: CONTACT

Inna.Chen@regionh.dk

+45 38682898

Facility Contacts

Inna Chen, MD

Role: primary

Inna.Chen@regionh.dk

+45 38682898

Dorte Nielsen, MD DMSc

Role: backup

Dorte.Nielsen.01@regionh.dk

+45 38682344

Other Identifiers

AA2058

Identifier Type: -

Identifier Source: org_study_id