跳至主要内容
临床试验/NCT02845479
NCT02845479已完成3 期

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

The Canadian College of Naturopathic Medicine4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年12月7日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
22
试验地点
4
主要终点
Feasibility of study protocol

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Integrative Care Intervention

Experimental

Broad-based, multi-agent integrative care program delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care.

干预措施: Integrative Care (Other)

结局指标

主要结局

Feasibility of study protocol

时间窗: Enrollment - 1 year post surgery

Percentage of participants who complete all assessments and integrative care appointments

次要结局

  • Compliance: supplemental intervention(Enrollment - 1 year post surgery)
  • Compliance: mental/emotional domain(Enrollment - 1 year post surgery)
  • Feasibility of recruitment(Enrollment)
  • Compliance: nutritional intervention(Enrollment - 1 year post surgery)
  • Communication between practitioners(Enrollment - 1 year post surgery)
  • Compliance: physical intervention(Enrollment - 1 year post surgery)
  • Qualitative experience of care and study protocol(Enrollment - 1 year post surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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