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

Phase 3

Completed

• Conditions: Esophageal Neoplasms; Lung Neoplasms; Stomach Neoplasms
• Interventions: Other: Integrative Care

• Registration Number: NCT02845479
• Lead Sponsor: The Canadian College of Naturopathic Medicine

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.

Study Timeline

• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Study Start: 2018-12-07
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Feasibility of study protocol	Enrollment - 1 year post surgery	Percentage of participants who complete all assessments and integrative care appointments

Secondary Outcome Measures

Name	Time	Method
Compliance: supplemental intervention	Enrollment - 1 year post surgery	Count of missed doses assessed by patient diary.
Compliance: mental/emotional domain	Enrollment - 1 year post surgery	Number of days audio-recordings were used assessed by patient diary.
Feasibility of recruitment	Enrollment	Percentage of participants recruited out of potentially eligible patients invited.
Compliance: nutritional intervention	Enrollment - 1 year post surgery	Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery
Communication between practitioners	Enrollment - 1 year post surgery	Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant
Compliance: physical intervention	Enrollment - 1 year post surgery	Extent of adherence to physical activity recommendations assessed using a patient diary.
Qualitative experience of care and study protocol	Enrollment - 1 year post surgery	Semi-structured interviews with thematic analysis

Trial Locations

Locations (2)

Ottawa General Hospital; 🇨🇦 Ottawa, Ontario, Canada

Ottawa Integrative Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada