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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lung Neoplasms, Esophageal Neoplasms, Stomach Neoplasms

Intervention / Treatment
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* Other: Integrative Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Care Intervention<br>Broad-based, multi-agent integrative care program delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care. | Other: Integrative Care<br>* 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).<br>|

What is the study measuring?
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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 |