The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage II
- Conditions
- Esophageal CancerLung CancerGastric Cancer
- Interventions
- Dietary Supplement: Vitamin D3 DropsDietary Supplement: Coriolus VersicolorDietary Supplement: Probiotic Pro12Dietary Supplement: Provitalix Pure Whey ProteinDietary Supplement: Theracurmin 2XDietary Supplement: Green Tea ExtractOther: Nutrition RecommendationsOther: Physical Activity RecommendationsBehavioral: Psychological Recommendations
- Registration Number
- NCT04871412
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
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. Too many clinical trials focus on single agent therapies, rather than broad multi-faceted individualized and integrative care interventions that are used in real world settings.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Integrative Care (Treatment) Green Tea Extract Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation Integrative Care (Treatment) Physical Activity Recommendations Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation Integrative Care (Treatment) Psychological Recommendations Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation Integrative Care (Treatment) Vitamin D3 Drops Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation Integrative Care (Treatment) Coriolus Versicolor Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation Integrative Care (Treatment) Nutrition Recommendations Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation Integrative Care (Treatment) Probiotic Pro12 Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation Integrative Care (Treatment) Provitalix Pure Whey Protein Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation Integrative Care (Treatment) Theracurmin 2X Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
- Primary Outcome Measures
Name Time Method Participant Recruitment Rates At the end of recruitment (estimated 1 year) Measured by the number of people who are enrolled in the study compared to the total number screened.
Cross-over and contamination in the control arm - Supplement usage 1 Year Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Information on the number of supplements used and the length of use use will be collected at each standard of care visit.
Cross-over and contamination in the control arm - Mediterranean Diet Scores 1 year Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Mediterranean diet scores (scale of 0-9) will be calculated in the control group using the Harvard Food Frequency Questionnaire to assess for changes over the 1 year follow up period.
Cross-over and contamination in the control arm - Psychological Health Activities 1 Year Measured by the number of participants in the control arm who perform activities in which the goal of the activity was to improve mental and emotional health.
Participant Retention Rates 2 Years Measured by the number of people who enrol in the study but subsequently withdraw. These numbers will be compared between arms.
Cross-over and contamination in the control arm - Physical Activity levels 1 Year Changes in physical activity will be monitored using the International Physical Activity Questionnaire, which is used to calculate total metabolic equivalent task (MET) minutes.
- Secondary Outcome Measures
Name Time Method Qualitative Experience 2 years Evaluate the qualitative experience of care of participants in both arms through semi-structured interviews
Natural Killer Cell Function Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery Measured by serum Interferon Gamma Levels
Inflammatory Response Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery Measured by serum C-Reactive Protein Levels
Communication 2 years Assessing the type and frequency of communications between research staff at The Ottawa Hospital (TOH) and the Centre for Health Innovation (CHI), as well as within TOH and the CHI through number of emails, phone calls, meetings (in-person or virtual) or any other communication method.
Neutrophil to Lymphocyte Ratio Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery Measured by collecting a complete blood count with differential and comparing neutrophil and lymphocyte levels
Trial Locations
- Locations (2)
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Michael Garron Hospital
🇨🇦Toronto, Ontario, Canada