NCT02484131

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?".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

June 12, 2015

Last Update Submit

March 23, 2017

Conditions

OsteoporosisBreast Cancer

Keywords

OsteoporosisDXA ScreeningWomenBreast CancerSurvivorsEducational materialsPersonal choices on delivery methods

Outcome Measures

Primary Outcomes (1)

  • DXA screening rates

    6 months

Secondary Outcomes (5)

  • Percentage of participants diagnosed with osteoporosis

    6 months

  • Percentage of participants initiating osteoporosis medication

    6 months

  • Changes in Calcium in take

    6 months

  • Changes in vitamin D status

    6 months

  • Changes in exercise patterns

    6 months

Study Arms (3)

Educational materials/mail

EXPERIMENTAL

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

Behavioral: Educational materials/mail

Educational materials/participant choice

EXPERIMENTAL

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

Behavioral: Educational materials/participant choice

Control

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.

Interventions

Educational materials/mailBEHAVIORAL

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

Educational materials/mail
Educational materials/participant choiceBEHAVIORAL

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

Educational materials/participant choice

Eligibility Criteria

Age65 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer Research Centre

Vancouver, British Columbia, V5Z 1L3, Canada

Location

MeSH Terms

Conditions

OsteoporosisBreast Neoplasms

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Martin Dawes, MD, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • John J. Spinelli, PhD

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
data analyst
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. MSc

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 29, 2015

Study Start

November 1, 2015

Primary Completion

February 20, 2017

Study Completion

March 20, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

CA(1)