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Study of a Supportive App Using Weekly Patient-Reported Outcomes for Adults with Advanced Pancreatic or Biliary Tract Cancer
Led by Inna Chen, MD · Updated on 2024-10-02
274
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate a supportive application with integrated weekly Patient-Reported Outcomes PRO for patients with advanced pancreatic or biliary tract cancer who are starting systemic treatment. These cancers are among the leading causes of cancer-related deaths, often causing severe physical and psychological issues and frequent unplanned hospitalizations. The study includes an initial feasibility phase followed by a possible randomized controlled trial to improve treatment care, reduce hospitalizations, and enhance patient outcomes. The study has two parts Part A involves 30 patients using a web-based supportive application to report symptoms weekly, which staff monitor daily and use to guide interventions. If Part A shows feasibility, Part B will randomize patients to either the supportive application or standard care to assess the impact on hospitalizations, quality of life, survival, satisfaction with oncologist communication, and healthcare resource use. Standard care includes regular symptom monitoring during clinical visits and encouragement to report concerning symptoms by phone. Participants will complete quality of life questionnaires at the start and at 12 and 24 weeks, along with a survey measuring satisfaction with oncologist communication. The study measures feasibility over 3 months in Part A and hospitalization over 6 months in Part B, with overall survival tracked for one year. The trial runs until April 2027 and includes continuous monitoring and reporting of patient symptoms to guide care throughout the study.
CONDITIONS
Brief Title
Study of PRO in Patients with Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay)
Research Team
I
Inna M Chen, MD
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