Strategies to Improve Bone Health in Men on ADT

March 20, 2018 updated by: University Health Network, Toronto

A Phase II RCT of Strategies to Improve Bone Health in Men on ADT

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this RCT the investigators are comparing 2 strategies to improve bone health to usual care. Strategy 1 - Patient and physician-specific written educational material. Pilot-tested customized written educational material about bone health for men on ADT will be used for this study. A customized letter will be prepared for the patient's primary care physician, with specific advice and recommendations for the targeted strategies. Both pamphlet and letter will include a list of additional resources. Strategy 2 - patient written material and a bone health care coordinator (BHCC). The same written patient material as in strategy 1 will be used, along with a BHCC who will follow the approach of successful studies and contact the patient by phone or arrange an in-person visit at the hospital if preferred by the patient. The BHCC will also encourage the patient to pursue a bone mineral density test (BMD) with their physician and adopt bone-appropriate diet, lifestyle, and supplement intake recommendations, and will follow up with the patient at least twice over the next 3 months to facilitate behavioural changes and BMD ordering. Counselling sessions are short, typically <15 min. The BHCC will also contact the patient's physician to help facilitate BMD testing. Time points in the study are baseline, 3-month follow up, and 6-month follow up.

Control group The control group consists of a wait-list control for 6 months, during which no specific recommendations or interventions will be made by the study team. Prostate Cancer (PC) clinicians can still provide usual care. At the end of 6 months, control group participants will be referred to the Osteoporosis Clinic at the University Health Network.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy bones pamphlet, letter to GP
Strategy 1: Written educational material to patient and GP
Behavioral: Healthy bones pamphlet
written educational material
Other Names:
  • Building strong bones
Behavioral: Letter to GP
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.
Active Comparator: Healthy bones pamphlet, Bone Health Care Coordinator
Strategy 2: Written educational material to patient and counseling from a Bone Health Care Coordinator
Behavioral: Healthy bones pamphlet
written educational material
Other Names:
  • Building strong bones
Behavioral: Bone Health Care Coordinator
The Bone Health Care Coordinator reviews educational materials with participant and facilitates ordering BMD.
Other Names:
  • BHCC
No Intervention: Usual care
Control group gets usual care from their oncologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient/physician satisfaction
Time Frame: 6 months
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
Time Frame: 6 months
Adherence to following through on recommendations/referrals related to study intervention and clinical outcomes.
6 months
Recruitment rate
Time Frame: 6 months
Enrolled patients divided by approached eligible patients, and reasons for both ineligibility and refusal as documented in logs.
6 months
Retention rate
Time Frame: 6 months
Proportion of patients available for follow-up outcome assessment.
6 months
BMD ordering
Time Frame: 6 months
Rate of Bone Mineral Density ordering
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Cancer Society (CCS)

Investigators

  • Principal Investigator: Shabbir Alibhai, MD, UHN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-6823

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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