A Phase II RCT of Strategies to Improve Bone Health in Men on ADT
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- Recruitment rate
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: 6 months
Enrolled patients divided by approached eligible patients, and reasons for both ineligibility and refusal as documented in logs.
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
Adherence rate
Time Frame: 6 months
Adherence to following through on recommendations/referrals related to study intervention and clinical outcomes.
Retention rate
Time Frame: 6 months
Proportion of patients available for follow-up outcome assessment.
BMD ordering
Time Frame: 6 months
Rate of Bone Mineral Density ordering
Secondary Outcomes
No secondary outcomes reported