Lung NeoplasmsPhase 3POISENCT02845479
The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I
A Phase 3 study testing Integrative Care in people with Lung Neoplasms and Esophageal Neoplasms, run by The Canadian College of Naturopathic Medicine at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Esophageal Neoplasms, Stomach Neoplasms
- What is being tested?
- Integrative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesCanada
- Study dates
- 7 Dec 2018to 7 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Ottawa General Hospital
Ottawa, Ontario, K1Y 1J7
Ottawa Integrative Cancer Centre
Ottawa, Ontario, K1Y2E5
About this study
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
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.
Read the 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.
- Conditions
- Lung Neoplasms, Esophageal Neoplasms, Stomach Neoplasms
- Being tested
- Integrative Care
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative CareOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Integrative Care Intervention | Experimental | Broad-based, multi-agent integrative care program delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care. Receives: Other: Integrative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study protocol
Percentage of participants who complete all assessments and integrative care appointments
Measured: Enrollment - 1 year post surgery
Secondary outcomes (7)
Compliance: supplemental intervention
Count of missed doses assessed by patient diary.
Measured: Enrollment - 1 year post surgery
Compliance: nutritional intervention
Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery
Measured: Enrollment - 1 year post surgery
Compliance: physical intervention
Extent of adherence to physical activity recommendations assessed using a patient diary.
Measured: Enrollment - 1 year post surgery
Compliance: mental/emotional domain
Number of days audio-recordings were used assessed by patient diary.
Measured: Enrollment - 1 year post surgery
Communication between practitioners
Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant
Measured: Enrollment - 1 year post surgery
Qualitative experience of care and study protocol
Semi-structured interviews with thematic analysis
Measured: Enrollment - 1 year post surgery
Feasibility of recruitment
Percentage of participants recruited out of potentially eligible patients invited.
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start7 Dec 2018
- Primary completion1 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Canadian College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, Lotte & John Hecht Memorial Foundation
- Responsible party
- Sponsor
- Investigators
- Dugald MR Seely, ND, MSc, Principal investigator, Canadian College of Naturopathic MedicineAndrew JE Seely, MD, PhD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845479
- Sponsor's protocol ID
- 20150449-01H
- Acronym
- POISE
- Status last verified
- Sep 2024
- First submitted
- 13 Jul 2016
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02845479
- Acronym / sponsor ID
- POISE / 20150449-01H
- Conditions
- Lung Neoplasms, Esophageal Neoplasms, Stomach Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Canadian College of Naturopathic MedicineUniversity, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, Lotte & John Hecht Memorial Foundation
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrative Care Intervention | Experimental | Other: Integrative CareBroad-based, multi-agent integrative care program delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative CareStandardized 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). | Other | Integrative Care Intervention |
Primary outcome
Feasibility of study protocol
Time frame: Enrollment - 1 year post surgery
Percentage of participants who complete all assessments and integrative care appointments
7 secondary outcomes
Compliance: supplemental intervention
Time frame: Enrollment - 1 year post surgery
Compliance: nutritional intervention
Time frame: Enrollment - 1 year post surgery
Compliance: physical intervention
Time frame: Enrollment - 1 year post surgery
Compliance: mental/emotional domain
Time frame: Enrollment - 1 year post surgery
Communication between practitioners
Time frame: Enrollment - 1 year post surgery
Qualitative experience of care and study protocol
Time frame: Enrollment - 1 year post surgery
Feasibility of recruitment
Time frame: Enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dugald MR Seely, ND, MSc principal investigator
Canadian College of Naturopathic Medicine
Andrew JE Seely, MD, PhD principal investigator
Ottawa Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Integrative Care in people with Lung Neoplasms and Esophageal Neoplasms, run by The Canadian College of Naturopathic Medicine at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study protocol (time frame: Enrollment - 1 year post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.