Clinical trial NCT04871412: The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage III
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 III
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lung Cancer
Gastric Cancer
Esophageal Cancer
Keywords: Natural Health Products
Thoracic Cancer
Surgery
Integrative Care
Nutrition
Physical Activity
Psychological Health
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Canadian College of Naturopathic Medicine
name: Lotte & John Hecht Memorial Foundation
name: The Centre for Health Innovation
name: University of Ottawa
First posted: 2021-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria

• Adults eligible for complete resection of lung, gastric or esophageal cancer

Exclusion criteria

* Small cell, carcinoid, or gastrointestinal stromal (GIST) tumours
* Any wedge resections of lung cancer
* History of cancer with active treatment in the last 3 years (not including superficial bladder cancer or non-melanoma skin cancer)
* Patients currently receiving care guided by an ND or who have previously seen an ND in the last 3 months
* Pregnant or breastfeeding women\*
* Any reason which, in the opinion of the Principal Investigator (or delegate), would prevent the subject from participating in the study
* Use of an investigational drug or participation in an investigational study within 30 days prior to starting the study

Primary outcomes:
measure: Participant Recruitment Rates
timeFrame: At the end of recruitment (estimated 1 year)
measure: Participant Retention Rates
timeFrame: 2 Years
measure: Cross-over and contamination in the control arm - Supplement usage
timeFrame: 1 Year
measure: Cross-over and contamination in the control arm - Mediterranean Diet Scores
timeFrame: 1 year
measure: Cross-over and contamination in the control arm - Physical Activity levels
timeFrame: 1 Year
measure: Cross-over and contamination in the control arm - Psychological Health Activities
timeFrame: 1 Year
Secondary outcomes:
measure: Communication
timeFrame: 2 years
measure: Natural Killer Cell Function
timeFrame: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
measure: Qualitative Experience
timeFrame: 2 years
measure: Inflammatory Response
timeFrame: Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery
measure: Neutrophil to Lymphocyte Ratio
timeFrame: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Michael Garron Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Andrew Seely, MD, PhD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: The Canadian College of Naturopathic Medicine
name: Dugald Seely, ND, MSc
role: PRINCIPAL_INVESTIGATOR
References: