The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I

Titre officiel

Pioneering Pre- and Post-Operative Integrative Care to Improve Thoracic Cancer Quality of Care: The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I

Sommaire:

La première étape de l’étude Thoracic POISE (Thoracic Peri-Operative Integrative Surgical Care Evaluation) consistera à mettre à l’essai une intervention de soins intégratifs à base de plusieurs agents, à grande échelle, mise en œuvre par des naturopathes, en association avec des soins chirurgicaux et oncologiques classiques chez des personnes atteintes d’un cancer thoracique.

Description de l'essai

Primary Outcome:

  • Feasibility of study protocol
Secondary Outcome:
  • Compliance: supplemental intervention
  • Compliance: nutritional intervention
  • Compliance: physical intervention
  • Compliance: mental/emotional domain
  • Communication between practitioners
  • Qualitative experience of care and study protocol
  • Feasibility of recruitment
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. 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. This multi-stage project aims to design, pilot-test and evaluate a broad-based, multi-agent, evidence-based integrative care program to be delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care. It is hypothesized that this integrative care program will improve HRQoL as well as reduce surgical adverse events and improve cancer survival. Stage I of the project will pilot-test the intervention and outcomes collection in a single-arm, feasibility study.

Voir cet essai sur ClinicalTrials.gov

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