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

NCT02845479 | Completed Phase 3 DMC

• 1 other identifier: 20150449-01H
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Neoplasms; Esophageal Neoplasms; Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• Feasibility of study protocol

  Percentage of participants who complete all assessments and integrative care appointments

  Enrollment - 1 year post surgery

Secondary Outcomes (7)

• Compliance: supplemental intervention

  Enrollment - 1 year post surgery

• Compliance: nutritional intervention

  Enrollment - 1 year post surgery

• Compliance: physical intervention

  Enrollment - 1 year post surgery

• Compliance: mental/emotional domain

  Enrollment - 1 year post surgery

• Communication between practitioners

  Enrollment - 1 year post surgery

Other Outcomes (8)

• Adverse events

  Enrollment - 1 year post surgery

• Health Related Quality of Life

  Enrollment - 1 year post surgery

• Cancer-related symptoms

  Enrollment - 1 year post surgery

Study Arms (1)

Integrative Care Intervention

EXPERIMENTAL

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

Other: Integrative Care

Interventions

Integrative Care 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).

Integrative Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead
• Ottawa Hospital Research Institute: collaborator
• Lotte & John Hecht Memorial Foundation: collaborator

Study Sites (2)

Ottawa General Hospital

Ottawa, Ontario, K1Y 1J7, Canada

Location

Ottawa Integrative Cancer Centre

Ottawa, Ontario, K1Y2E5, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Dugald MR Seely, ND, MSc

  Canadian College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

• Andrew JE Seely, MD, PhD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 27, 2016
• Study Start: December 7, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 7, 2020
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)