The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage III
Recruiting · NCT04871412 · Interventional (participants receive a specific treatment) · Lead sponsor: Ottawa Hospital Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Adults eligible for complete resection of lung, gastric or esophageal cancer
Exclusion criteria
- Small cell, carcinoid, or gastrointestinal stromal (GIST) tumours
- Any wedge resections of lung cancer
- History of cancer with active treatment in the last 3 years (not including superficial bladder cancer or non-melanoma skin cancer)
- Patients currently receiving care guided by an ND or who have previously seen an ND in the last 3 months
- Pregnant or breastfeeding women\*
- Any reason which, in the opinion of the Principal Investigator (or delegate), would prevent the subject from participating in the study
- Use of an investigational drug or participation in an investigational study within 30 days prior to starting the study
Where it is running
2 locations listed.
- The Ottawa Hospital - Ottawa, Ontario, Canada
- Michael Garron Hospital - Toronto, Ontario, Canada