Supportive application for patients with advanced pancreatic or biliary tract cancer
Study of Supportive Application with Integrated Patient-Reported Outcomes in Patients with Advanced Pancreatic or BiliaryTract Cancer (BetterEveryDay)
This study is testing a new web-based app that helps patients with advanced pancreatic or biliary tract cancer share their health updates to see if it improves their care and overall experience during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 274 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT04611867 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the care of patients with advanced pancreatic and biliary tract cancer by integrating weekly Patient-Reported Outcomes (PRO) into their treatment regimen. Initially, 30 patients will participate in a feasibility phase to assess the practicality of using a web-based application for self-reporting their health status. If successful, a randomized controlled trial will follow to evaluate the impact of this supportive application on unplanned hospitalizations, quality of life, survival rates, and overall satisfaction with oncologist communication. The study focuses on patients initiating systemic therapy for their cancer.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with confirmed advanced pancreatic or lung cancer who are about to start their first line of systemic therapy.
Not a fit: Patients with significant cognitive dysfunction or those participating in conflicting interventional studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce unplanned hospitalizations and improve the quality of life for patients with advanced cancer.
How similar studies have performed: While the integration of Patient-Reported Outcomes in cancer care is gaining traction, this specific approach is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Herlev
- Herlev & Gentofte University Hospital, Denmark — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Inna M Chen, MD — Herlev and Gentofte Hospital
- Study coordinator: Inna M Chen, MD
- Email: Inna.Chen@regionh.dk
- Phone: +45 38682898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.