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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
1,000 - 10,000 units daily based on serum levels for the duration of the study
1.5g twice daily for the duration of the study
3g once daily for the duration of the study
12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)
1 scoop (22g) once daily during the peri-operative period (approximately 1 month pre and post-surgery) and during any adjuvant chemotherapy and radiation treatments
1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation
700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.
Based on the Mediterranean diet and lower glycemic index foods
150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days
Activities with the intention of actively improving the participant's mental and emotional health
The Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGMichael Garron Hospital
Toronto, Ontario, Canada
RECRUITINGParticipant Recruitment Rates
Measured by the number of people who are enrolled in the study compared to the total number screened.
Time frame: At the end of recruitment (estimated 1 year)
Participant Retention Rates
Measured by the number of people who enrol in the study but subsequently withdraw. These numbers will be compared between arms.
Time frame: 2 Years
Cross-over and contamination in the control arm - Supplement usage
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.
Time frame: 1 Year
Cross-over and contamination in the control arm - Mediterranean Diet Scores
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.
Time frame: 1 year
Cross-over and contamination in the control arm - Physical Activity levels
Changes in physical activity will be monitored using the International Physical Activity Questionnaire, which is used to calculate total metabolic equivalent task (MET) minutes.
Time frame: 1 Year
Cross-over and contamination in the control arm - Psychological Health Activities
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.
Time frame: 1 Year
Communication
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.
Time frame: 2 years
Natural Killer Cell Function
Measured by serum Interferon Gamma Levels
Time frame: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Qualitative Experience
Evaluate the qualitative experience of care of participants in both arms through semi-structured interviews
Time frame: 2 years
Inflammatory Response
Measured by serum C-Reactive Protein Levels
Time frame: Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery
Neutrophil to Lymphocyte Ratio
Measured by collecting a complete blood count with differential and comparing neutrophil and lymphocyte levels
Time frame: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
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