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

NCT ID: NCT02845479

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-07
• Study Completion Date: 2020-12-07

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.

Conditions

Lung Neoplasms; Esophageal Neoplasms; Stomach Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Integrative Care Intervention

Broad-based, multi-agent integrative care program delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care.

Group Type: EXPERIMENTAL

Integrative Care

Intervention Type: OTHER

Standardized supplemental/natural health product, physical, nutritional and mental/emotional recommendations based on the phases of standard care (neo-adjuvant, perioperative, adjuvant and long-term maintenance).

Interventions

Integrative Care

Standardized supplemental/natural health product, physical, nutritional and mental/emotional recommendations based on the phases of standard care (neo-adjuvant, perioperative, adjuvant and long-term maintenance).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

Lotte & John Hecht Memorial Foundation

OTHER

Sponsor Role: collaborator

The Canadian College of Naturopathic Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dugald MR Seely, ND, MSc

Role: PRINCIPAL_INVESTIGATOR

Canadian College of Naturopathic Medicine

Andrew JE Seely, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Ottawa General Hospital

Ottawa, Ontario, Canada

Ottawa Integrative Cancer Centre

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20150449-01H

Identifier Type: -

Identifier Source: org_study_id