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OpenTrials
Completed

NCT Number: NCT02484131

Bone Health Management for Women Diagnosed With Breast Cancer

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?".

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Key information

Age range

65 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BC Cancer Research Centre

Vancouver, British Columbia, V5Z 1L3, Canada

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational materials/mail

Behavioral

Participants in this group will receive any educational materials by mail during hte follow-up period.

Educational materials/participant choice

Behavioral

Participants in this group will not receive any educational materials by participant choice during hte follow-up period.

Primary outcomes

  1. DXA screening rates

    Time frame: 6 months

Secondary outcomes

  1. Percentage of participants diagnosed with osteoporosis

    Time frame: 6 months

  2. Percentage of participants initiating osteoporosis medication

    Time frame: 6 months

  3. Changes in Calcium in take

    Time frame: 6 months

    measured as mg per week using validated questionnaires

  4. Changes in vitamin D status

    Time frame: 6 months

    measured as scores using validated questionnaires

  5. Changes in exercise patterns

    Time frame: 6 months

    measured as scores using validated questionnaires

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • British Columbia Cancer Agency

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2015
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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