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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2024 |
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Main ID: |
NCT02845479 |
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Date of registration:
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13/07/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I
POISE |
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Scientific title:
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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 |
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Date of first enrolment:
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December 7, 2018 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02845479 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Andrew JE Seely, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ottawa Hospital Research Institute |
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Name:
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Dugald MR Seely, ND, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Canadian College of Naturopathic Medicine |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Esophageal Neoplasms
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Lung Neoplasms
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Stomach Neoplasms
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Intervention(s)
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Other: Integrative Care
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Primary Outcome(s)
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Feasibility of study protocol
[Time Frame: Enrollment - 1 year post surgery]
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Secondary Outcome(s)
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Compliance: nutritional intervention
[Time Frame: Enrollment - 1 year post surgery]
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Feasibility of recruitment
[Time Frame: Enrollment]
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Qualitative experience of care and study protocol
[Time Frame: Enrollment - 1 year post surgery]
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Compliance: physical intervention
[Time Frame: Enrollment - 1 year post surgery]
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Compliance: supplemental intervention
[Time Frame: Enrollment - 1 year post surgery]
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Communication between practitioners
[Time Frame: Enrollment - 1 year post surgery]
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Compliance: mental/emotional domain
[Time Frame: Enrollment - 1 year post surgery]
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Secondary ID(s)
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20150449-01H
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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