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.

Study Overview

• Status: Completed
• Conditions: Locally Advanced Malignant Neoplasm
• Intervention / Treatment: Behavioral: Bone health educational materials

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bone health educational materials; Bone health written educational materials, Bone health prescription,verbal counselling	Behavioral: Bone health educational materials
No Intervention: Usual care; Usual clinical care to be provided by oncologists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Canadian Association of Radiation Oncology
• Investigators: Principal Investigator: Shabbir Alibhai, MD, UHN

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimate): October 31, 2013

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: prostate cancer; ADT; bone health
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 13-6050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO