Prostate Cancer
Conditions
Keywords
Prostate cancer, Androgen deprivation therapy, Bone health, Bone mineral density
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.
Interventions
BEHAVIORALHealthy bones pamphlet
written educational material
BEHAVIORALBone Health Care Coordinator
The Bone Health Care Coordinator reviews educational materials with participant and facilitates ordering BMD.
BEHAVIORALLetter 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.
Sponsors
Canadian Cancer Society (CCS)
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 6 months | Enrolled patients divided by approached eligible patients, and reasons for both ineligibility and refusal as documented in logs. |
| Retention rate | 6 months | Proportion of patients available for follow-up outcome assessment. |
| 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. |
| BMD ordering | 6 months | Rate of Bone Mineral Density ordering |
Countries
Canada
Outcome results
None listed