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临床试验/NCT03773380
NCT03773380已完成1 期

Breathe Anew: Designing and Testing the Feasibility of a Novel Intervention for Lung Cancer Survivorship

St. Joseph's Healthcare Hamilton1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月2日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Compliance

研究概览

简要总结

Survivorship programs have become an integral component of modern cancer care programs. In Canada, there has been tremendous success for survivorship programs for breast, prostate, and colorectal cancer, however lung cancer survivorship programs have not been widely developed. The complexity of the disease, high mortality, short survival times, high cost of surveillance, and patient habits have traditionally been barriers against the success of lung cancer survivorship programs. The investigator proposes a feasibility study to pilot a novel intervention titled Breathe Anew, which will aim to identify and overcome the barriers to the design and implementation of a lung cancer survivorship program. The investigator has assembled a multi-disciplinary team of experts and lung cancer survivors who will develop the Breathe Anew survivorship intervention. The intervention will be vetted using an integrated knowledge translation approach, which will involve members of the target population, primarily patients who previously underwent lung resection, to modify the intervention and ensure acceptability. After Breathe Anew has been designed, it will be tested in a pilot study of 50 patients to ensure its feasibility and determine its cost. The ultimate goal of this feasibility study is to lay the groundwork for a subsequent comparative trial to evaluate the impact of Breathe Anew on patient-important outcomes including health related quality and length of life and postoperative complications.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •Age 18 years or older
  • •All patients at St. Joseph's Healthcare Hamilton who received lung resection for Stage I, Stage II, or Stage IIIa Non-Small Cell Lung Cancer are eligible to enroll.
  • •Owns a smart device

排除标准

  • •Patients who received lung resection for Stage IIIb or IV Non-Small Cell Lung Cancer
  • •Patients with affected mobility (walker, wheelchair)
  • •Patients who use oxygen at home

研究组 & 干预措施

Feasibility

Experimental

50 patients will be recruited to take part in this feasibility study. They will all undergo this Breathe Anew Program post-surgery. Breathe Anew consists of radiological surveillance, physical rehabilitation using a Fitbit, mindfulness therapy, and referral for symptom management specialists when needed.

干预措施: Breathe Anew Survivorship Program (Combination Product)

结局指标

主要结局

Compliance

时间窗: 12 months

The feasibility of Breath Anew, as measured by a rate of compliance of \>70% with all the components of the intervention.

次要结局

  • Accrual Rate(12 months)
  • Cost Per Patient(12 months)
  • Patient-Reported Satisfaction(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wael Hanna

Associate Professor of Surgery

St. Joseph's Healthcare Hamilton

研究点 (1)

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