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

Pancreatic Cancer Clinical Trial

— BetterEveryDay  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611867
• Other study ID #: AA2058
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: April 1, 2027

Study information

• Verified date: September 2023
• Source: Herlev Hospital
• Contact: Inna M Chen, MD
• Phone: +45 38682898
• Email: Inna.Chen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Nonsmall Cell
• Pancreatic Cancer

Intervention

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.

Locations

Country	Name	City	State
Denmark	Herlev & Gentofte University Hospital, Denmark	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Inna Chen, MD	Roche Pharma AG

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Out-of-patient care and resource utilization	- Time to first ER visit and/or hospitalization	6 months
Other	Out-of-patient care and resource utilization	- Rates of hospital admissions	6 months
Other	Out-of-patient care and resource utilization	- Mean length of hospital stay	6 months
Other	Out-of-patient care and resource utilization	- Number of additional/unplanned nursing calls	6 months
Other	Out-of-patient care and resource utilization	- Number of additional/unplanned out-patient care visits	6 months
Other	Tolerability of systemic therapy	- Time receiving active cancer treatment	6 months
Primary	Feasibility (Part A)	- Proportion of enrolled patients responding to at least two consecutive questionnaires by 12 weeks	3 months
Primary	Hospitalization (Part B)	- 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	EORTC QLQ-C30 global health status/QoL scale	- Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 12 and 24 weeks	6 months
Secondary	EORTC QLQ-C30 functional scales and symptom scales/items	- Adjusted mean change from baseline in functional and symptom scales from the EORTC QLQ-C30 questionnaire at 6, 12 and 24 weeks.	6 months
Secondary	Overall survival	- Overall survival	1 year
Secondary	Satisfaction with oncologist communication at 12 and 24 weeks as measured by the modified Health Care Climate Questionnaire (HCCQ)	- Adjusted mean in score from the modified HCCQ at 12 and 24 weeks.	6 months