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

September 21, 2023 updated by: Inna Chen, MD

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

274

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
No Intervention: 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (Part A)
Time Frame: 3 months
- Proportion of enrolled patients responding to at least two consecutive questionnaires by 12 weeks
3 months
Hospitalization (Part B)
Time Frame: 6 months
- Hospitalization with any unplanned admission to the hospital and/or emergency department within the 24 weeks beginning from the day of randomization.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-C30 global health status/QoL scale
Time Frame: 6 months
- Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 12 and 24 weeks
6 months
EORTC QLQ-C30 functional scales and symptom scales/items
Time Frame: 6 months
- Adjusted mean change from baseline in functional and symptom scales from the EORTC QLQ-C30 questionnaire at 6, 12 and 24 weeks.
6 months
Overall survival
Time Frame: 1 year
- Overall survival
1 year
Satisfaction with oncologist communication at 12 and 24 weeks as measured by the modified Health Care Climate Questionnaire (HCCQ)
Time Frame: 6 months
- Adjusted mean in score from the modified HCCQ at 12 and 24 weeks.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Out-of-patient care and resource utilization
Time Frame: 6 months
- Time to first ER visit and/or hospitalization
6 months
Out-of-patient care and resource utilization
Time Frame: 6 months
- Rates of hospital admissions
6 months
Out-of-patient care and resource utilization
Time Frame: 6 months
- Mean length of hospital stay
6 months
Out-of-patient care and resource utilization
Time Frame: 6 months
- Number of additional/unplanned nursing calls
6 months
Out-of-patient care and resource utilization
Time Frame: 6 months
- Number of additional/unplanned out-patient care visits
6 months
Tolerability of systemic therapy
Time Frame: 6 months
- Time receiving active cancer treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Inna M Chen, MD, Herlev and Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2021

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

October 30, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Supportive application with integrated weekly PRO

3
Subscribe