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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Herlev & Gentofte University Hospital, Denmark
RECRUITING
Herlev
Contact Information
Primary
Inna M Chen, MD
Inna.Chen@regionh.dk
+45 38682898
Time Frame
Start Date: 2021-08-17
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 274
Treatments
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
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.
Related Therapeutic Areas
Sponsors
Leads: Inna Chen, MD
Collaborators: Roche Pharma AG

This content was sourced from clinicaltrials.gov