The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage II

Phase 3

Recruiting

• Conditions: Esophageal Cancer; Lung Cancer; Gastric Cancer

• 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

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Study Start: 2022-04-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2028-12-01
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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.
Qualitative Experience	2 years	Evaluate the qualitative experience of care of participants in both arms through semi-structured interviews
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