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 III
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Participant Recruitment Rates
研究概览
简要总结
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. Too many clinical trials focus on single agent therapies, rather than broad multi-faceted individualized and integrative care interventions that are used in real world settings.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults eligible for complete resection of lung, gastric or esophageal cancer
排除标准
- •Small cell, carcinoid, or gastrointestinal stromal (GIST) tumours
- •Any wedge resections of lung cancer
- •History of cancer with active treatment in the last 3 years (not including superficial bladder cancer or non-melanoma skin cancer)
- •Patients currently receiving care guided by an ND or who have previously seen an ND in the last 3 months
- •Pregnant or breastfeeding women*
- •Any reason which, in the opinion of the Principal Investigator (or delegate), would prevent the subject from participating in the study
- •Use of an investigational drug or participation in an investigational study within 30 days prior to starting the study
研究组 & 干预措施
Integrative Care (Treatment)
Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
干预措施: Vitamin D3 Drops (Dietary Supplement)
Integrative Care (Treatment)
Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
干预措施: Coriolus Versicolor (Dietary Supplement)
Integrative Care (Treatment)
Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
干预措施: Trident SAP 66:33 Lemon (Dietary Supplement)
Integrative Care (Treatment)
Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
干预措施: Probiotic Pro12 (Dietary Supplement)
Integrative Care (Treatment)
Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
干预措施: Provitalix Pure Whey Protein (Dietary Supplement)
Integrative Care (Treatment)
Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
干预措施: Theracurmin 2X (Dietary Supplement)
Integrative Care (Treatment)
Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
干预措施: Green Tea Extract (Dietary Supplement)
Integrative Care (Treatment)
Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
干预措施: Nutrition Recommendations (Other)
Integrative Care (Treatment)
Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
干预措施: Physical Activity Recommendations (Other)
Integrative Care (Treatment)
Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation
干预措施: Psychological Recommendations (Behavioral)
Standard Care (Control)
Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital
结局指标
主要结局
Participant Recruitment Rates
时间窗: At the end of recruitment (estimated 1 year)
Measured by the number of people who are enrolled in the study compared to the total number screened.
Cross-over and contamination in the control arm - Supplement usage
时间窗: 1 Year
Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Information on the number of supplements used and the length of use use will be collected at each standard of care visit.
Cross-over and contamination in the control arm - Mediterranean Diet Scores
时间窗: 1 year
Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Mediterranean diet scores (scale of 0-9) will be calculated in the control group using the Harvard Food Frequency Questionnaire to assess for changes over the 1 year follow up period.
Cross-over and contamination in the control arm - Psychological Health Activities
时间窗: 1 Year
Measured by the number of participants in the control arm who perform activities in which the goal of the activity was to improve mental and emotional health.
Participant Retention Rates
时间窗: 2 Years
Measured by the number of people who enrol in the study but subsequently withdraw. These numbers will be compared between arms.
Cross-over and contamination in the control arm - Physical Activity levels
时间窗: 1 Year
Changes in physical activity will be monitored using the International Physical Activity Questionnaire, which is used to calculate total metabolic equivalent task (MET) minutes.
次要结局
- Natural Killer Cell Function(Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery)
- Inflammatory Response(Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery)
- Communication(2 years)
- Qualitative Experience(2 years)
- Neutrophil to Lymphocyte Ratio(Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery)