Overview

This trial is active, not recruiting.

Conditions osteoporosis, breast cancer
Treatments educational materials/mail, educational materials/participant choice
Sponsor University of British Columbia
Collaborator British Columbia Cancer Agency
Start date August 2015
End date December 2016
Trial size 54 participants
Trial identifier NCT02484131, H15-00849

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?".

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants in this group will receive educational materials by mail on the first day of the follow-up period.
educational materials/mail
Participants in this group will receive any educational materials by mail during hte follow-up period.
(Experimental)
Participants in this group will receive educational materials by participant choice on the first day of the follow-up period.
educational materials/participant choice
Participants in this group will not receive any educational materials by participant choice during hte follow-up period.
(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.

Primary Outcomes

Measure
DXA screening rates
time frame: 6 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 65 years up to 75 years old.

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

Additional Information

Official title Bone Health Management for Women Diagnosed With Breast Cancer: A Pilot Study
Principal investigator Martin Dawes, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.