The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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).
|
Outcome Measures
Primary Outcome Measures
- Feasibility of study protocol [Enrollment - 1 year post surgery]
Percentage of participants who complete all assessments and integrative care appointments
Secondary Outcome Measures
- Compliance: supplemental intervention [Enrollment - 1 year post surgery]
Count of missed doses assessed by patient diary.
- Compliance: nutritional intervention [Enrollment - 1 year post surgery]
Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery
- Compliance: physical intervention [Enrollment - 1 year post surgery]
Extent of adherence to physical activity recommendations assessed using a patient diary.
- Compliance: mental/emotional domain [Enrollment - 1 year post surgery]
Number of days audio-recordings were used assessed by patient diary.
- Communication between practitioners [Enrollment - 1 year post surgery]
Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant
- Qualitative experience of care and study protocol [Enrollment - 1 year post surgery]
Semi-structured interviews with thematic analysis
- Feasibility of recruitment [Enrollment]
Percentage of participants recruited out of potentially eligible patients invited.
Other Outcome Measures
- Adverse events [Enrollment - 1 year post surgery]
Collection of adverse events related to surgery, adjuvant therapy, and the interventions
- Health Related Quality of Life [Enrollment - 1 year post surgery]
Functional Assessment of Cancer Therapy-General Score
- Cancer-related symptoms [Enrollment - 1 year post surgery]
Edmonton Symptom Assessment Scale
- Anxiety and Depression [Enrollment - 1 year post surgery]
Hospital Anxiety and Depression Scale
- Fatigue [Enrollment - 1 year post surgery]
Multidimensional Fatigue Inventory
- Functional exercise capacity [Enrollment - 1 year post surgery]
6 minute walk test
- Inflammation: Multi-analyte cytokine array. [Enrollment - 1 year post surgery]
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
- Natural kill cell activation [Enrollment - 1 year post surgery]
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
Eligibility Criteria
Criteria
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
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Understand and sign a written informed consent form in English or French
Exclusion Criteria:
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Small cell, carcinoid, or gastrointestinal stromal (GIST) tumours
-
History of cancer in the last 3 years
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Already seeing a ND or involved in an integrative program of care in the last 3 months that includes complementary medicine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ottawa General Hospital | Ottawa | Ontario | Canada | K1Y 1J7 |
| 2 | Ottawa Integrative Cancer Centre | Ottawa | Ontario | Canada | K1Y2E5 |
Sponsors and Collaborators
- The Canadian College of Naturopathic Medicine
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20150449-01H