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

Last updated: September 18, 2024
Sponsor: The Canadian College of Naturopathic Medicine
Overall Status: Completed

Phase

3

Condition

Neoplasms

Esophageal Disorders

Digestive System Neoplasms

Treatment

Integrative Care

Clinical Study ID

NCT02845479
20150449-01H
  • Ages > 18
  • All Genders

Study Summary

Stage I of the Thoracic-POISE study will pilot-test a broad-based, multi-agent integrative care intervention delivered by naturopathic doctors in conjunction with standard surgical and oncologic care of people with thoracic cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults eligible and scheduled for major thoracic surgery for lung, gastric oresophageal cancer

  • Candidate for complete resection

  • Willingness to include an integrative component to their care

  • Availability for follow-up visits over the course of one year

  • Willingness to be interviewed regarding their experience of care

  • Ability to answer self- and interviewer- administered questions in English or French

  • Understand and sign a written informed consent form in English or French

Exclusion

Exclusion Criteria:

  • Small cell, carcinoid, or gastrointestinal stromal (GIST) tumours

  • History of cancer in the last 3 years

  • Already seeing a ND or involved in an integrative program of care in the last 3months that includes complementary medicine

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: Integrative Care
Phase: 3
Study Start date:
December 07, 2018
Estimated Completion Date:
December 07, 2020

Study Description

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.

Connect with a study center

  • Ottawa General Hospital

    Ottawa, Ontario K1Y 1J7
    Canada

    Site Not Available

  • Ottawa Integrative Cancer Centre

    Ottawa, Ontario K1Y2E5
    Canada

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.