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Trial record 1 of 1 for:    NCT02845479
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The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I (POISE)

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ClinicalTrials.gov Identifier: NCT02845479
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : April 27, 2023
Sponsor:
Collaborators:
Ottawa Hospital Research Institute
Lotte & John Hecht Memorial Foundation
Information provided by (Responsible Party):
The Canadian College of Naturopathic Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Esophageal Neoplasms Stomach Neoplasms Other: Integrative Care Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 7, 2018
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Integrative Care Intervention
Broad-based, multi-agent integrative care program delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of study protocol [ Time Frame: Enrollment - 1 year post surgery ]
    Percentage of participants who complete all assessments and integrative care appointments


Secondary Outcome Measures :
  1. Compliance: supplemental intervention [ Time Frame: Enrollment - 1 year post surgery ]
    Count of missed doses assessed by patient diary.

  2. Compliance: nutritional intervention [ Time Frame: Enrollment - 1 year post surgery ]
    Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery

  3. Compliance: physical intervention [ Time Frame: Enrollment - 1 year post surgery ]
    Extent of adherence to physical activity recommendations assessed using a patient diary.

  4. Compliance: mental/emotional domain [ Time Frame: Enrollment - 1 year post surgery ]
    Number of days audio-recordings were used assessed by patient diary.

  5. Communication between practitioners [ Time Frame: Enrollment - 1 year post surgery ]
    Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant

  6. Qualitative experience of care and study protocol [ Time Frame: Enrollment - 1 year post surgery ]
    Semi-structured interviews with thematic analysis

  7. Feasibility of recruitment [ Time Frame: Enrollment ]
    Percentage of participants recruited out of potentially eligible patients invited.


Other Outcome Measures:
  1. Adverse events [ Time Frame: Enrollment - 1 year post surgery ]
    Collection of adverse events related to surgery, adjuvant therapy, and the interventions

  2. Health Related Quality of Life [ Time Frame: Enrollment - 1 year post surgery ]
    Functional Assessment of Cancer Therapy-General Score

  3. Cancer-related symptoms [ Time Frame: Enrollment - 1 year post surgery ]
    Edmonton Symptom Assessment Scale

  4. Anxiety and Depression [ Time Frame: Enrollment - 1 year post surgery ]
    Hospital Anxiety and Depression Scale

  5. Fatigue [ Time Frame: Enrollment - 1 year post surgery ]
    Multidimensional Fatigue Inventory

  6. Functional exercise capacity [ Time Frame: Enrollment - 1 year post surgery ]
    6 minute walk test

  7. Inflammation: Multi-analyte cytokine array. [ Time Frame: Enrollment - 1 year post surgery ]
    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

  8. Natural kill cell activation [ Time Frame: Enrollment - 1 year post surgery ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845479


Locations
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Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada, K1Y 1J7
Ottawa Integrative Cancer Centre
Ottawa, Ontario, Canada, K1Y2E5
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Ottawa Hospital Research Institute
Lotte & John Hecht Memorial Foundation
Investigators
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Principal Investigator: Dugald MR Seely, ND, MSc Canadian College of Naturopathic Medicine
Principal Investigator: Andrew JE Seely, MD, PhD Ottawa Hospital Research Institute
More Information
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Responsible Party: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT02845479    
Other Study ID Numbers: 20150449-01H
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Lung Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases