Bone Health Management for Women Diagnosed With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Bone Health Management for Women Diagnosed With Breast Cancer: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484131
• Other study ID #: H15-00849
• Status: Completed
• Phase: N/A
• First received: June 12, 2015
• Last updated: March 23, 2017
• Start date: November 2015
• Est. completion date: March 20, 2017

Study information

• Verified date: March 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 selected choice change DXA screening rates compared to the conventional mail method?".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 20, 2017
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Osteoporosis

Intervention

Behavioral:
• Educational materials/mail
Participants in this group will receive any educational materials by mail during hte 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.

Locations

Country	Name	City	State
Canada	BC Cancer Research Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DXA screening rates		6 months
Secondary	Percentage of participants diagnosed with osteoporosis		6 months
Secondary	Percentage of participants initiating osteoporosis medication		6 months
Secondary	Changes in Calcium in take	measured as mg per week using validated questionnaires	6 months
Secondary	Changes in vitamin D status	measured as scores using validated questionnaires	6 months
Secondary	Changes in exercise patterns	measured as scores using validated questionnaires	6 months