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| Name | Class |
|---|---|
| Ottawa Hospital Research Institute | OTHER |
| Lotte & John Hecht Memorial Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrative Care Intervention | Experimental | Broad-based, multi-agent integrative care program delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative Care | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of study protocol | Percentage of participants who complete all assessments and integrative care appointments | Enrollment - 1 year post surgery |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dugald MR Seely, ND, MSc | Canadian College of Naturopathic Medicine | Principal Investigator |
| Andrew JE Seely, MD, PhD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa General Hospital | Ottawa | Ontario | K1Y 1J7 | Canada | ||
| Ottawa Integrative Cancer Centre |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| 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 |
| Ottawa |
| Ontario |
| K1Y2E5 |
| Canada |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |