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Completed

NCT Number: NCT02845479

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ottawa General Hospital, Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Feasibility of study protocol

    Time frame: Enrollment - 1 year post surgery

    Percentage of participants who complete all assessments and integrative care appointments

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Canadian College of Naturopathic Medicine

Other

Collaborators

  • Lotte & John Hecht Memorial Foundation
  • Ottawa Hospital Research Institute

Registry information

Official study 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

Acronym: POISE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2016
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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