Healthy Bones Study
Healthy Bones Study: An Intervention to Improve Healthy Bone Behaviours in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
- Before/control arm (Before arm) Usual care by Princess Margaret Cancer Centre (PM) oncologist.
- After/intervention arm (After arm) Provision of a healthy bones prescription, verbal counselling, and written educational materials regarding healthy bone behaviours by PM oncologist or delegate (e.g. clinical fellow), in addition to usual care by oncologist. The intervention may be delivered again at a subsequent follow-up at the request of the patient and/or at the discretion of the oncologist.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Bone health educational materials
Bone health written educational materials, Bone health prescription,verbal counselling
|
|
|
Nessun intervento: Usual care
Usual clinical care to be provided by oncologists.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Recruitment rate
Lasso di tempo: 6 months
|
Proportion of eligible and consented patients who complete study follow-up, as a measure of study feasibility
|
6 months
|
|
Study completion and retention rate
Lasso di tempo: 3 months
|
Change in patient-reported daily calcium intake, as a measure of intervention efficacy
|
3 months
|
|
Intervention efficacy
Lasso di tempo: 3 months
|
Change in patient-reported weekly exercise duration, as a measure of intervention efficacy
|
3 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Clinical outcome
Lasso di tempo: 6 months
|
Proportion of patients whose calcium, vitamin D intake, and exercise may be assessed from properly completed questionnaires
|
6 months
|
|
Clinical outcome capture rate
Lasso di tempo: 6 months
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Patient and clinician satisfaction with clinical study on a ten-point scale
|
6 months
|
|
Questionnaire, and Osteoporosis Health Belief Scale
Lasso di tempo: 3 months
|
Change in patient knowledge and health benefits regarding osteoporosis, as determined with Facts on Osteoporosis Quiz - Revised, Men's Osteoporosis Knowledge
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3 months
|
|
BMD monitoring
Lasso di tempo: 6 months
|
Proportion of enrolled patients having bone mineral density (BMD) tests performed within 6 months of ADT initiation
|
6 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Shabbir Alibhai, MD, UHN
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 13-6050
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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