Integrative Care
OtherStandardized 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).
NCT Number: NCT02845479
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Ottawa General Hospital, Ottawa, Ontario, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Enrollment - 1 year post surgery
Percentage of participants who complete all assessments and integrative care appointments
Time frame: Enrollment - 1 year post surgery
Count of missed doses assessed by patient diary.
Time frame: Enrollment - 1 year post surgery
Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery
Time frame: Enrollment - 1 year post surgery
Extent of adherence to physical activity recommendations assessed using a patient diary.
Time frame: Enrollment - 1 year post surgery
Number of days audio-recordings were used assessed by patient diary.
Time frame: Enrollment - 1 year post surgery
Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant
Time frame: Enrollment - 1 year post surgery
Semi-structured interviews with thematic analysis
Time frame: Enrollment
Percentage of participants recruited out of potentially eligible patients invited.
Time frame: Enrollment - 1 year post surgery
Collection of adverse events related to surgery, adjuvant therapy, and the interventions
Time frame: Enrollment - 1 year post surgery
Functional Assessment of Cancer Therapy-General Score
Time frame: Enrollment - 1 year post surgery
Edmonton Symptom Assessment Scale
Time frame: Enrollment - 1 year post surgery
Hospital Anxiety and Depression Scale
Time frame: Enrollment - 1 year post surgery
Multidimensional Fatigue Inventory
Time frame: Enrollment - 1 year post surgery
6 minute walk test
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
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
The Canadian College of Naturopathic Medicine
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT00041808
Adenocarcinoma, Breast Diseases
San Diego, California, United States
View Trial DetailsNCT07035587
Adnexal Diseases, Colonic Diseases
Seoul, South Korea
View Trial DetailsNCT05944237
Adenoma, Colonic Diseases
Cambridge, United Kingdom
View Trial DetailsNCT07682220
Behavior, Digestive System Diseases
Harbin, Heilongjiang, China
View Trial Details