- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02484131
Bone Health Management for Women Diagnosed With Breast Cancer
March 23, 2017 updated by: 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?".
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
"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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1L3
- BC Cancer Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 75 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational materials/mail
Participants in this group will receive educational materials by mail on the first day of the follow-up period.
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Participants in this group will receive any educational materials by mail during hte follow-up period.
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Experimental: 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.
|
No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
DXA screening rates
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants diagnosed with osteoporosis
Time Frame: 6 months
|
6 months
|
|
Percentage of participants initiating osteoporosis medication
Time Frame: 6 months
|
6 months
|
|
Changes in Calcium in take
Time Frame: 6 months
|
measured as mg per week using validated questionnaires
|
6 months
|
Changes in vitamin D status
Time Frame: 6 months
|
measured as scores using validated questionnaires
|
6 months
|
Changes in exercise patterns
Time Frame: 6 months
|
measured as scores using validated questionnaires
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Dawes, MD, PhD, University of British Columbia
- Principal Investigator: John J. Spinelli, PhD, British Columbia Cancer Agency
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2015
Primary Completion (Actual)
February 20, 2017
Study Completion (Actual)
March 20, 2017
Study Registration Dates
First Submitted
June 12, 2015
First Submitted That Met QC Criteria
June 24, 2015
First Posted (Estimate)
June 29, 2015
Study Record Updates
Last Update Posted (Actual)
March 27, 2017
Last Update Submitted That Met QC Criteria
March 23, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H15-00849
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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