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

Lung Neoplasms Clinical Trial

— POISE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845479
• Other study ID #: 20150449-01H
• Status: Completed
• Phase: Phase 3
• Start date: December 7, 2018
• Est. completion date: December 7, 2020

Study information

• Verified date: March 2024
• Source: The Canadian College of Naturopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 7, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Lung Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Ottawa Integrative Cancer Centre	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine	Lotte & John Hecht Memorial Foundation, Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Collection of adverse events related to surgery, adjuvant therapy, and the interventions	Enrollment - 1 year post surgery
Other	Health Related Quality of Life	Functional Assessment of Cancer Therapy-General Score	Enrollment - 1 year post surgery
Other	Cancer-related symptoms	Edmonton Symptom Assessment Scale	Enrollment - 1 year post surgery
Other	Anxiety and Depression	Hospital Anxiety and Depression Scale	Enrollment - 1 year post surgery
Other	Fatigue	Multidimensional Fatigue Inventory	Enrollment - 1 year post surgery
Other	Functional exercise capacity	6 minute walk test	Enrollment - 1 year post surgery
Other	Inflammation: Multi-analyte cytokine array.	Plasma concentrations of a panel of cytokines (IL2, IL10, TGF-beta, TNF-alpha, IFN-alpha, and IFN-gamma) will be measured in blood samples collected 4 weeks before surgery, 2-3 days before surgery, on post-operative day (POD) 1, POD 5 (+/-2), 3-4 weeks, 6 months and 1 year post-surgery	Enrollment - 1 year post surgery
Other	Natural kill cell activation	NK cell activity will be measured by NKVue™ in blood samples collected 4 weeks before surgery, 2-3 days before surgery, on post-operative day (POD) 1, POD 5 (+/-2), 3-4 weeks, 6 months and 1 year post-surgery	Enrollment - 1 year post surgery
Primary	Feasibility of study protocol	Percentage of participants who complete all assessments and integrative care appointments	Enrollment - 1 year post surgery
Secondary	Compliance: supplemental intervention	Count of missed doses assessed by patient diary.	Enrollment - 1 year post surgery
Secondary	Compliance: nutritional intervention	Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery	Enrollment - 1 year post surgery
Secondary	Compliance: physical intervention	Extent of adherence to physical activity recommendations assessed using a patient diary.	Enrollment - 1 year post surgery
Secondary	Compliance: mental/emotional domain	Number of days audio-recordings were used assessed by patient diary.	Enrollment - 1 year post surgery
Secondary	Communication between practitioners	Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant	Enrollment - 1 year post surgery
Secondary	Qualitative experience of care and study protocol	Semi-structured interviews with thematic analysis	Enrollment - 1 year post surgery
Secondary	Feasibility of recruitment	Percentage of participants recruited out of potentially eligible patients invited.	Enrollment