The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I

The Canadian College of Naturopathic Medicine

Status and phase

Completed

Phase 3

Conditions

Lung Neoplasms

Stomach Neoplasms

Esophageal Neoplasms

Treatments

Other: Integrative Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02845479

20150449-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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