Strategies to Improve Bone Health in Men on ADT

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Healthy bones pamphlet; Behavioral: Bone Health Care Coordinator; Behavioral: Letter to GP

• Registration Number: NCT02043236
• Lead Sponsor: University Health Network, Toronto

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).

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-23
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 159

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy bones pamphlet, Bone Health Care Coordinator	Healthy bones pamphlet	Strategy 2: Written educational material to patient and counseling from a Bone Health Care Coordinator
Healthy bones pamphlet, Bone Health Care Coordinator	Bone Health Care Coordinator	Strategy 2: Written educational material to patient and counseling from a Bone Health Care Coordinator
Healthy bones pamphlet, letter to GP	Letter to GP	Strategy 1: Written educational material to patient and GP
Healthy bones pamphlet, letter to GP	Healthy bones pamphlet	Strategy 1: Written educational material to patient and GP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada