Breathe Anew for Lung Cancer Survivorship (BA)
2022年3月3日 更新者:Wael Hanna、St. Joseph's Healthcare Hamilton
Breathe Anew: Designing and Testing the Feasibility of a Novel Intervention for Lung Cancer Survivorship
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.
研究概览
研究类型
介入性
注册 (实际的)
50
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
-
Hamilton、Ontario、加拿大、L8N 4A6
- St. Joseph's Healthcare Hamilton
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Feasibility
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.
|
The feasibility will be tested of the Breathe Anew Survivorship Program
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Compliance
大体时间:12 months
|
The feasibility of Breath Anew, as measured by a rate of compliance of >70% with all the components of the intervention.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Accrual Rate
大体时间:12 months
|
Rate of accrual to the intervention
|
12 months
|
|
Patient-Reported Satisfaction
大体时间:12 months
|
Using the EQ-5D-5L, which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life.
The EQ-5D-5L asks the participant to indicate what best describes their health on the day the scale is administered and it consists of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression which are measured by a severity scale from 1-5 (no problems = 1, slight problems = 2, moderate problems = 3, severe problems = 4, or completely unable to = 5).
|
12 months
|
|
Cost Per Patient
大体时间:12 months
|
Cost per patient for the duration of the intervention
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年1月2日
初级完成 (实际的)
2022年1月1日
研究完成 (实际的)
2022年1月1日
研究注册日期
首次提交
2018年12月10日
首先提交符合 QC 标准的
2018年12月10日
首次发布 (实际的)
2018年12月12日
研究记录更新
最后更新发布 (实际的)
2022年3月4日
上次提交的符合 QC 标准的更新
2022年3月3日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.