Clinical trial NCT02845479: The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
name: Lotte & John Hecht Memorial Foundation
First posted: 2016-07-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stage I of the Thoracic-POISE study will pilot-test a broad-based, multi-agent integrative care intervention delivered by naturopathic doctors in conjunction with standard surgical and oncologic care of people with thoracic cancer.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of study protocol
timeFrame: Enrollment - 1 year post surgery
Secondary outcomes:
measure: Compliance: supplemental intervention
timeFrame: Enrollment - 1 year post surgery
measure: Compliance: nutritional intervention
timeFrame: Enrollment - 1 year post surgery
measure: Compliance: physical intervention
timeFrame: Enrollment - 1 year post surgery
measure: Compliance: mental/emotional domain
timeFrame: Enrollment - 1 year post surgery
measure: Communication between practitioners
timeFrame: Enrollment - 1 year post surgery
measure: Qualitative experience of care and study protocol
timeFrame: Enrollment - 1 year post surgery
measure: Feasibility of recruitment
timeFrame: Enrollment
Other outcomes:
measure: Adverse events
timeFrame: Enrollment - 1 year post surgery
measure: Health Related Quality of Life
timeFrame: Enrollment - 1 year post surgery
measure: Cancer-related symptoms
timeFrame: Enrollment - 1 year post surgery
measure: Anxiety and Depression
timeFrame: Enrollment - 1 year post surgery
measure: Fatigue
timeFrame: Enrollment - 1 year post surgery
measure: Functional exercise capacity
timeFrame: Enrollment - 1 year post surgery
measure: Inflammation: Multi-analyte cytokine array.
timeFrame: Enrollment - 1 year post surgery
measure: Natural kill cell activation
timeFrame: Enrollment - 1 year post surgery
Locations:
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Integrative Cancer Centre
state: Ontario
Study officials:
affiliation: Canadian College of Naturopathic Medicine
name: Dugald MR Seely, ND, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Andrew JE Seely, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: