Strategies to Improve Bone Health in Men on ADT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Healthy bones pamphlet
* Behavioral: Bone Health Care Coordinator
* Behavioral: Letter to GP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Androgen deprivation therapy, Bone health, Bone mineral density