Healthy Bones Study

Locally Advanced Malignant Neoplasm Clinical Trial

Official title:

Healthy Bones Study: An Intervention to Improve Healthy Bone Behaviours in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973673
• Other study ID #: 13-6050
• Status: Completed
• Phase: N/A
• First received: September 30, 2013
• Last updated: May 3, 2017
• Start date: September 2013
• Est. completion date: March 1, 2017

Study information

• Verified date: May 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

1. Before/control arm (Before arm) Usual care by Princess Margaret Cancer Centre (PM) oncologist.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Malignant Neoplasm
• Neoplasms

Intervention

Behavioral:
• Bone health educational materials

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Association of Radiation Oncology

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Proportion of eligible and consented patients who complete study follow-up, as a measure of study feasibility	6 months
Primary	Study completion and retention rate	Change in patient-reported daily calcium intake, as a measure of intervention efficacy	3 months
Primary	Intervention efficacy	Change in patient-reported weekly exercise duration, as a measure of intervention efficacy	3 months
Secondary	Clinical outcome	Proportion of patients whose calcium, vitamin D intake, and exercise may be assessed from properly completed questionnaires	6 months
Secondary	Clinical outcome capture rate	Patient and clinician satisfaction with clinical study on a ten-point scale	6 months
Secondary	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
Secondary	BMD monitoring	Proportion of enrolled patients having bone mineral density (BMD) tests performed within 6 months of ADT initiation	6 months