Bone Health Management for Women Diagnosed With Breast Cancer

NCT ID: NCT02484131

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

"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

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
data analyst

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Educational materials/mail

Participants in this group will receive educational materials by mail on the first day of the follow-up period.

Group Type EXPERIMENTAL

Educational materials/mail

Intervention Type BEHAVIORAL

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 receive educational materials by participant choice on the first day of the follow-up period.

Group Type EXPERIMENTAL

Educational materials/participant choice

Intervention Type BEHAVIORAL

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

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Educational materials/mail

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

Intervention Type BEHAVIORAL

Educational materials/participant choice

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

British Columbia Cancer Agency

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Olivia Tseng, MD

MD. MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Dawes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

John J. Spinelli, PhD

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Agency

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

BC Cancer Research Centre

Vancouver, British Columbia, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H15-00849

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Breathing and Bones Initiative
NCT01161680 COMPLETED
Healthy Bones Study
NCT01973673 COMPLETED NA
Radiation Effects on Bone
NCT03134742 ENROLLING_BY_INVITATION