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

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

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.

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasms; Lung Neoplasms; Esophageal Neoplasms
• Intervention / Treatment: Other: Integrative Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 1J7
      • Ottawa General Hospital
    • Ottawa, Ontario, Canada, K1Y2E5
      • Ottawa Integrative Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults eligible and scheduled for major thoracic surgery for lung, gastric or esophageal 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 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 3 months that includes complementary medicine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrative Care Intervention; Broad-based, multi-agent integrative care program delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care.	Other: Integrative Care; Standardized supplemental/natural health product, physical, nutritional and mental/emotional recommendations based on the phases of standard care (neo-adjuvant, perioperative, adjuvant and long-term maintenance).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of study protocol	Percentage of participants who complete all assessments and integrative care appointments	Enrollment - 1 year post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance: supplemental intervention	Count of missed doses assessed by patient diary.	Enrollment - 1 year post surgery
Compliance: nutritional intervention	Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery	Enrollment - 1 year post surgery
Compliance: physical intervention	Extent of adherence to physical activity recommendations assessed using a patient diary.	Enrollment - 1 year post surgery
Compliance: mental/emotional domain	Number of days audio-recordings were used assessed by patient diary.	Enrollment - 1 year post surgery
Communication between practitioners	Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant	Enrollment - 1 year post surgery
Qualitative experience of care and study protocol	Semi-structured interviews with thematic analysis	Enrollment - 1 year post surgery
Feasibility of recruitment	Percentage of participants recruited out of potentially eligible patients invited.	Enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Collection of adverse events related to surgery, adjuvant therapy, and the interventions	Enrollment - 1 year post surgery
Health Related Quality of Life	Functional Assessment of Cancer Therapy-General Score	Enrollment - 1 year post surgery
Cancer-related symptoms	Edmonton Symptom Assessment Scale	Enrollment - 1 year post surgery
Anxiety and Depression	Hospital Anxiety and Depression Scale	Enrollment - 1 year post surgery
Fatigue	Multidimensional Fatigue Inventory	Enrollment - 1 year post surgery
Functional exercise capacity	6 minute walk test	Enrollment - 1 year post surgery
Inflammation: Multi-analyte cytokine array.	Plasma concentrations of a panel of cytokines (IL2, IL10, TGF-beta, TNF-alpha, IFN-alpha, and IFN-gamma) will be measured in blood samples collected 4 weeks before surgery, 2-3 days before surgery, on post-operative day (POD) 1, POD 5 (+/-2), 3-4 weeks, 6 months and 1 year post-surgery	Enrollment - 1 year post surgery
Natural kill cell activation	NK cell activity will be measured by NKVue™ in blood samples collected 4 weeks before surgery, 2-3 days before surgery, on post-operative day (POD) 1, POD 5 (+/-2), 3-4 weeks, 6 months and 1 year post-surgery	Enrollment - 1 year post surgery

Collaborators and Investigators

• Sponsor: The Canadian College of Naturopathic Medicine
• Collaborators: Ottawa Hospital Research Institute; Lotte & John Hecht Memorial Foundation
• Investigators: Principal Investigator: Dugald MR Seely, ND, MSc, Canadian College of Naturopathic Medicine; Principal Investigator: Andrew JE Seely, MD, PhD, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2018
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 7, 2020

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimated): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms; Stomach Neoplasms; Lung Neoplasms; Esophageal Neoplasms
• Other Study ID Numbers: 20150449-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No