Bone Health Management for Women Diagnosed With Breast Cancer
2017年3月23日 更新者：Olivia Tseng, MD、University of British Columbia
Bone Health Management for Women Diagnosed With Breast Cancer: A Pilot Study
The purpose of this study is to test the feasibility of the study protocol.
The study protocol was designed to evaluate questions - "Do educational materials improve dual x-ray absorptiometry (DXA) screening rates for women diagnosed with breast cancer" and "Does educational materials delivered by the participant's selected choice change DXA screening rates compared to the conventional mail method?".
研究概览
地位
完全的
详细说明
"Bone health management" for osteoporosis is important for women diagnosed with breast cancer.
Osteoporosis can lead to bones breaking easily.
Broken bones may make living independently challenging.
Effective bone health management can reduce the risk of broken bones.
This study will examine whether providing "osteoporosis information" to women diagnosed with breast cancer will promote their bone health management.
With the current advance in technology, people are more interested in receiving information by email or smartphone text messaging.
This study will also examine whether delivering osteoporosis information in different ways will change bone health management.
研究类型
介入性
注册 (实际的)
54
阶段
- 不适用
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
-
-
British Columbia
-
Vancouver、British Columbia、加拿大、V5Z 1L3
- BC Cancer Research Centre
-
-
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
65年 至 75年 (年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Women
- Is 65-75 year old on July 1st, 2015
- Lives in British Columbia (BC), Canada
- Reads and understands the information provided in English
- Was diagnosed with breast cancer prior to July 1st, 2012
- Is not receiving surgery, radiation or chemotherapy for any cancers
- Has not had breast cancer spread beyond her breast(s) and nearby lymph nodes
- Has not had screening tests after July 1st, 2012
- Is not taking medications prescribed by doctors for osteoporosis
Exclusion criteria:
- Is medically unfit for preventive care (death, cognitive impairment, nursing home admission, severe mental illness, etc), which will be determined by their family doctors
- Have terminated patient-doctor relationship with her family doctor who is indicated in our record
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Educational materials/mail
Participants in this group will receive educational materials by mail on the first day of the follow-up period.
|
Participants in this group will receive any educational materials by mail during hte follow-up period.
|
|
实验性的：Educational materials/participant choice
Participants in this group will receive educational materials by participant choice on the first day of the follow-up period.
|
Participants in this group will not receive any educational materials by participant choice during hte follow-up period.
|
|
无干预：Control
Participants in this group will not receive any educational materials during hte follow-up period.
Educational materials will be sent by mail after the completion of this study.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
DXA screening rates
大体时间：6 months
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of participants diagnosed with osteoporosis
大体时间：6 months
|
6 months
|
|
|
Percentage of participants initiating osteoporosis medication
大体时间：6 months
|
6 months
|
|
|
Changes in Calcium in take
大体时间：6 months
|
measured as mg per week using validated questionnaires
|
6 months
|
|
Changes in vitamin D status
大体时间：6 months
|
measured as scores using validated questionnaires
|
6 months
|
|
Changes in exercise patterns
大体时间：6 months
|
measured as scores using validated questionnaires
|
6 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。
调查人员
- 首席研究员：Martin Dawes, MD, PhD、University of British Columbia
- 首席研究员：John J. Spinelli, PhD、British Columbia Cancer Agency
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)
2015年11月1日
初级完成 (实际的)
2017年2月20日
研究完成 (实际的)
2017年3月20日
研究注册日期
首次提交
2015年6月12日
首先提交符合 QC 标准的
2015年6月24日
首次发布 (估计)
2015年6月29日
研究记录更新
最后更新发布 (实际的)
2017年3月27日
上次提交的符合 QC 标准的更新
2017年3月23日
最后验证
2017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.