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

NCT04611867 | Recruiting

• 1 other identifier: AA2058
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Lung Cancer, Nonsmall Cell

Outcome Measures

Primary Outcomes (2)

• Feasibility (Part A)

  \- Proportion of enrolled patients responding to at least two consecutive questionnaires by 12 weeks

  3 months

• 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 Outcomes (4)

• EORTC QLQ-C30 global health status/QoL scale

  6 months

• EORTC QLQ-C30 functional scales and symptom scales/items

  6 months

• Overall survival

  1 year

• Satisfaction with oncologist communication at 12 and 24 weeks as measured by the modified Health Care Climate Questionnaire (HCCQ)

  6 months

Other Outcomes (6)

• Out-of-patient care and resource utilization

  6 months

• Out-of-patient care and resource utilization

  6 months

• Out-of-patient care and resource utilization

  6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Other: Supportive application with integrated weekly PRO

Standard Arm

NO INTERVENTION

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".

Interventions

Supportive application with integrated weekly PRO 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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inna Chen, MD: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Herlev & Gentofte University Hospital, Denmark

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Inna M Chen, MD

  Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inna M Chen, MD

CONTACT

+45 38682898; Inna.Chen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 2, 2020
• Study Start: August 17, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

DK (1)