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The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage III

Study acronym: POISE
StatusRecruiting
PhasePhase 3
Started2022-04-04
View on ClinicalTrials.gov ↗

Amendment history

2026-01-28
minor
Study Status v6
Re-verified, no change to tracked fields
2025-04-09
minor
Study Status, Contacts/Locations v5
Primary completion date2029-12-01→2028-12-01
Completion date2031-12-01→2029-12-01
Study sitesdetails revised at 1 of 2 sites
2024-09-19
minor
Study Identification, Study Status, Contacts/Locations v4
Primary completion date2024-12-01→2029-12-01
Completion date2025-12-01→2031-12-01
Study sites1→2
Study title+1 characters
The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage IIIII
2023-05-05
minor
Study Status v3
Primary completion date2024-05-01→2024-12-01
Completion date2025-05-01→2025-12-01
2022-04-08
notable
Not Yet Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-05-01→confirmed 2022-04-04
Enrollment target40→20
Study sitesdetails revised at 1 of 1 site
2022-03-14
minor
Study Status v1
Primary completion date2023-07-01→2024-05-01
Completion date2024-07-01→2025-05-01
Start date2021-07-01→2022-05-01
2021-04-29
minor
Original filing
Despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (\~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. These issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (HRQoL). On a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care. Too many clinical trials focus on single agent therapies, rather than broad multi-faceted individualized and integrative care interventions that are used in real world settings. The Thoracic POISE project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery.
Trial Details
NCT Number NCT04871412
Lead Sponsor Ottawa Hospital Research Institute
Collaborators: The Canadian College of Naturopathic Medicine, Lotte & John Hecht Memorial Foundation, The Centre for Health Innovation, University of Ottawa
Conditions Lung Cancer, Gastric Cancer, Esophageal Cancer
Enrollment 20 participants
Start Date 2022-04-04
Primary Completion 2028-12-01 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-30