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| Name | Class |
|---|---|
| Canadian Association of Radiation Oncology | INDUSTRY |
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Prostate cancer patients receiving hormone treatment (androgen deprivation therapy, or ADT) are at increased risk of developing bone loss and osteoporosis as side effects. To prevent this, guidelines recommend participation in healthy bone behaviours including weight-bearing exercise and adequate calcium/vitamin D intake. However, prior studies have shown that patients are not regularly screened or counselled regarding healthy bone behaviours while receiving ADT. Maintaining bone health in prostate cancer patients is important because men on ADT are at increased risk of fractures. In this study, the investigators will examine whether an intervention designed to improve healthy bone behaviours among prostate cancer patients on ADT can be implemented. The intervention consists of a written "healthy bones prescription", brief verbal counseling, and printed educational materials for participants. Investigators hope to obtain an initial estimate of whether the intervention works. They also hope to show that this simple intervention can be implemented in a real, working cancer clinic.
The investigators hypothesize that an intervention to improve bone health in prostate cancer patients receiving ADT (healthy bones prescription, verbal counseling, and printed educational materials) is effective, implementable, and accepted by clinicians and patients.
The study has a before-and-after design, to allow comparison of the intervention before its implementation and after its implementation. This design permits a reliable assessment of baseline characteristics prior to implementation of intervention and over time, particularly in situations where randomization is not feasible (e.g. due to contamination of treating physicians). The point at which the intervention will start to be delivered for new study participants is when 150 patients are accrued to the Before arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone health educational materials | Active Comparator | Bone health written educational materials, Bone health prescription,verbal counselling |
|
| Usual care | No Intervention | Usual clinical care to be provided by oncologists. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone health educational materials | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Proportion of eligible and consented patients who complete study follow-up, as a measure of study feasibility | 6 months |
| Study completion and retention rate | Change in patient-reported daily calcium intake, as a measure of intervention efficacy | 3 months |
| Intervention efficacy | Change in patient-reported weekly exercise duration, as a measure of intervention efficacy | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | Proportion of patients whose calcium, vitamin D intake, and exercise may be assessed from properly completed questionnaires | 6 months |
| Clinical outcome capture rate | Patient and clinician satisfaction with clinical study on a ten-point scale |
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Inclusion Criteria:
Prostate cancer patients receiving ADT at study entry (for a maximum of 12 months prior to study entry or planning to receive ADT within 3 weeks of study entry), for an expected duration of >6 months; Eastern Cooperative Oncology Group (ECOG) performance status <3
Exclusion Criteria: Unable to exercise (e.g. major physical disability, severe osteoarthritis, or other severe comorbidity); severe cardiac disease (congestive heart failure with New York Heart Association (NYHA) class >2, angioplasty/coronary artery bypass surgery within 3 months of study entry); patients with bone endocrinopathy (parathyroid disorders, osteomalacia); stage IV-V chronic kidney disease (estimated glomerular filtration rate [eGFR] <30 mL/min/1.75 m2; prior serum creatinine not required for entry into study); allergy to components of calcium & vitamin D tablets.
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| Name | Affiliation | Role |
|---|---|---|
| Shabbir Alibhai, MD | UHN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29532243 | Derived | Tsang DS, Jones JM, Samadi O, Shah S, Mitsakakis N, Catton CN, Jeon W, To J, Breunis H, Alibhai SMH. Healthy Bones Study: can a prescription coupled with education improve bone health for patients receiving androgen deprivation therapy?-a before/after study. Support Care Cancer. 2018 Aug;26(8):2861-2869. doi: 10.1007/s00520-018-4150-0. Epub 2018 Mar 12. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 6 months |
| Questionnaire, and Osteoporosis Health Belief Scale | Change in patient knowledge and health benefits regarding osteoporosis, as determined with Facts on Osteoporosis Quiz - Revised, Men's Osteoporosis Knowledge | 3 months |
| BMD monitoring | Proportion of enrolled patients having bone mineral density (BMD) tests performed within 6 months of ADT initiation | 6 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |