Clinical trial NCT02484131: Bone Health Management for Women Diagnosed With Breast Cancer
Official title: Bone Health Management for Women Diagnosed With Breast Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Breast Cancer
Keywords: Osteoporosis
DXA Screening
Women
Breast Cancer
Survivors
Educational materials
Personal choices on delivery methods
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: British Columbia Cancer Agency
First posted: 2015-06-29
Enrollment: 54
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: DXA screening rates
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of participants diagnosed with osteoporosis
timeFrame: 6 months
measure: Percentage of participants initiating osteoporosis medication
timeFrame: 6 months
measure: Changes in Calcium in take
timeFrame: 6 months
measure: Changes in vitamin D status
timeFrame: 6 months
measure: Changes in exercise patterns
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Research Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Martin Dawes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: British Columbia Cancer Agency
name: John J. Spinelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: