OsteoporosisNCT02484131
Bone Health Management for Women Diagnosed With Breast Cancer
A study testing Educational materials/mail and Educational materials/participant choice in people with Osteoporosis and Breast Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 75 years, women only
- Conditions the study is for
- Osteoporosis, Breast Cancer
- What is being tested?
- Educational materials/mail and Educational materials/participant choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to 20 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?".
Read the 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.
- Conditions
- Osteoporosis, Breast Cancer
- Being tested
- Educational materials/mail, Educational materials/participant choice
- Keywords
- Osteoporosis, DXA Screening, Women, Breast Cancer, Survivors, Educational materials, Personal choices on delivery methods
- Medical subject headings
- Osteoporosis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational materials/mailBehavioural
Participants in this group will receive any educational materials by mail during hte follow-up period.
Educational materials/participant choiceBehavioural
Participants in this group will not receive any educational materials by participant choice during hte follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Educational materials/mail | Experimental | Participants in this group will receive educational materials by mail on the first day of the follow-up period. Receives: Behavioral: Educational materials/mail |
| Educational materials/participant choice | Experimental | Participants in this group will receive educational materials by participant choice on the first day of the follow-up period. Receives: Behavioral: Educational materials/participant choice |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DXA screening rates
Measured: 6 months
Secondary outcomes (5)
Percentage of participants diagnosed with osteoporosis
Measured: 6 months
Percentage of participants initiating osteoporosis medication
Measured: 6 months
Changes in Calcium in take
measured as mg per week using validated questionnaires
Measured: 6 months
Changes in vitamin D status
measured as scores using validated questionnaires
Measured: 6 months
Changes in exercise patterns
measured as scores using validated questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startNov 2015
- Primary completion20 Feb 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Responsible party
- Principal investigator, Olivia Tseng, MD, University of British Columbia
- Investigators
- Martin Dawes, MD, PhD, Principal investigator, University of British ColumbiaJohn J. Spinelli, PhD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484131
- Sponsor's protocol ID
- H15-00849
- Status last verified
- Mar 2017
- First submitted
- 12 Jun 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Health Management for Women Diagnosed With Breast Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT02484131
- Acronym / sponsor ID
- H15-00849
- Conditions
- Osteoporosis, Breast Cancer
- Keywords
- Osteoporosis, DXA Screening, Women, Breast Cancer, Survivors, Educational materials, Personal choices on delivery methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Study start
- Nov 2015 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?".
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Educational materials/mail | Experimental | Behavioral: Educational materials/mailParticipants in this group will receive educational materials by mail on the first day of the follow-up period. |
| Educational materials/participant choice | Experimental | Behavioral: Educational materials/participant choiceParticipants in this group will receive educational materials by participant choice on the first day of the follow-up period. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational materials/mailParticipants in this group will receive any educational materials by mail during hte follow-up period. | Behavioural | Educational materials/mail |
| Educational materials/participant choiceParticipants in this group will not receive any educational materials by participant choice during hte follow-up period. | Behavioural | Educational materials/participant choice |
Primary outcome
DXA screening rates
Time frame: 6 months
5 secondary outcomes
Percentage of participants diagnosed with osteoporosis
Time frame: 6 months
Percentage of participants initiating osteoporosis medication
Time frame: 6 months
Changes in Calcium in take
Time frame: 6 months
Changes in vitamin D status
Time frame: 6 months
Changes in exercise patterns
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Dawes, MD, PhD principal investigator
University of British Columbia
John J. Spinelli, PhD principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational materials/mail and Educational materials/participant choice in people with Osteoporosis and Breast Cancer, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DXA screening rates (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.