NCT02043236

Brief Summary

This is a phase II randomized controlled trial (RCT) of 2 strategies to improve bone health in men receiving androgen deprivation therapy (ADT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable prostate-cancer

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

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

4.2 years

First QC Date

January 20, 2014

Last Update Submit

March 20, 2018

Conditions

Prostate Cancer

Keywords

Prostate cancerAndrogen deprivation therapyBone healthBone mineral density

Outcome Measures

Primary Outcomes (5)

  • Patient/physician satisfaction

    Satisfaction will be measured with 5-point Likert scale ranging from poor to excellent and administered to patient, PC clinician, and General Physician

    6 months

  • Adherence rate

    Adherence to following through on recommendations/referrals related to study intervention and clinical outcomes.

    6 months

  • Recruitment rate

    Enrolled patients divided by approached eligible patients, and reasons for both ineligibility and refusal as documented in logs.

    6 months

  • Retention rate

    Proportion of patients available for follow-up outcome assessment.

    6 months

  • BMD ordering

    Rate of Bone Mineral Density ordering

    6 months

Study Arms (3)

Healthy bones pamphlet, letter to GP

ACTIVE COMPARATOR

Strategy 1: Written educational material to patient and GP

Behavioral: Healthy bones pamphletBehavioral: Letter to GP

Healthy bones pamphlet, Bone Health Care Coordinator

ACTIVE COMPARATOR

Strategy 2: Written educational material to patient and counseling from a Bone Health Care Coordinator

Behavioral: Healthy bones pamphletBehavioral: Bone Health Care Coordinator

Usual care

NO INTERVENTION

Control group gets usual care from their oncologist.

Interventions

Healthy bones pamphletBEHAVIORAL

written educational material

Also known as: Building strong bones
Healthy bones pamphlet, Bone Health Care CoordinatorHealthy bones pamphlet, letter to GP
Bone Health Care CoordinatorBEHAVIORAL

The Bone Health Care Coordinator reviews educational materials with participant and facilitates ordering BMD.

Also known as: BHCC
Healthy bones pamphlet, Bone Health Care Coordinator
Letter to GPBEHAVIORAL

The letter to the General Practitioner contains information about the study, recommendations for bone health, guidelines of Osteoporosis Canada, and the identical educational material that the participant received.

Healthy bones pamphlet, letter to GP

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Commencing or planning to continue ADT for a least 6 months 50 years or older English fluency Life expectancy \>6 months

You may not qualify if:

  • Prior Bone Mineral Density test within 2 years Prior visit at Osteoporosis Clinic within 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5T 2M9, Canada

Location

Related Publications (1)

  • Alibhai SMH, Breunis H, Timilshina N, Hamidi MS, Cheung AM, Tomlinson GA, Manokumar T, Samadi O, Sandoval J, Durbano S, Warde P, Jones JM. Improving bone health in men with prostate cancer receiving androgen deprivation therapy: Results of a randomized phase 2 trial. Cancer. 2018 Mar 15;124(6):1132-1140. doi: 10.1002/cncr.31171. Epub 2017 Dec 6.

    PMID: 29211305DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Shabbir Alibhai, MD

    UHN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 23, 2014

Study Start

November 1, 2013

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)