The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I (POISE)
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|ClinicalTrials.gov Identifier: NCT02845479|
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : April 27, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms Esophageal Neoplasms Stomach Neoplasms||Other: Integrative Care||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 7, 2018|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||December 7, 2020|
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).
- Feasibility of study protocol [ Time Frame: Enrollment - 1 year post surgery ]Percentage of participants who complete all assessments and integrative care appointments
- Compliance: supplemental intervention [ Time Frame: Enrollment - 1 year post surgery ]Count of missed doses assessed by patient diary.
- Compliance: nutritional intervention [ Time Frame: Enrollment - 1 year post surgery ]Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery
- Compliance: physical intervention [ Time Frame: Enrollment - 1 year post surgery ]Extent of adherence to physical activity recommendations assessed using a patient diary.
- Compliance: mental/emotional domain [ Time Frame: Enrollment - 1 year post surgery ]Number of days audio-recordings were used assessed by patient diary.
- Communication between practitioners [ Time Frame: 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 [ Time Frame: Enrollment - 1 year post surgery ]Semi-structured interviews with thematic analysis
- Feasibility of recruitment [ Time Frame: Enrollment ]Percentage of participants recruited out of potentially eligible patients invited.
- Adverse events [ Time Frame: Enrollment - 1 year post surgery ]Collection of adverse events related to surgery, adjuvant therapy, and the interventions
- Health Related Quality of Life [ Time Frame: Enrollment - 1 year post surgery ]Functional Assessment of Cancer Therapy-General Score
- Cancer-related symptoms [ Time Frame: Enrollment - 1 year post surgery ]Edmonton Symptom Assessment Scale
- Anxiety and Depression [ Time Frame: Enrollment - 1 year post surgery ]Hospital Anxiety and Depression Scale
- Fatigue [ Time Frame: Enrollment - 1 year post surgery ]Multidimensional Fatigue Inventory
- Functional exercise capacity [ Time Frame: Enrollment - 1 year post surgery ]6 minute walk test
- Inflammation: Multi-analyte cytokine array. [ Time Frame: 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 [ Time Frame: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845479
|Ottawa General Hospital|
|Ottawa, Ontario, Canada, K1Y 1J7|
|Ottawa Integrative Cancer Centre|
|Ottawa, Ontario, Canada, K1Y2E5|
|Principal Investigator:||Dugald MR Seely, ND, MSc||Canadian College of Naturopathic Medicine|
|Principal Investigator:||Andrew JE Seely, MD, PhD||Ottawa Hospital Research Institute|
|Responsible Party:||The Canadian College of Naturopathic Medicine|
|Other Study ID Numbers:||
|First Posted:||July 27, 2016 Key Record Dates|
|Last Update Posted:||April 27, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Digestive System Neoplasms
Digestive System Diseases
Head and Neck Neoplasms