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Healthy Bones Study

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ClinicalTrials.gov Identifier: NCT01973673
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
Canadian Association of Radiation Oncology
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.


Condition or disease Intervention/treatment Phase
Locally Advanced Malignant Neoplasm Behavioral: Bone health educational materials Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Healthy Bones Study: An Intervention to Improve Healthy Bone Behaviours in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)
Study Start Date : September 2013
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 6 months ]
    Proportion of eligible and consented patients who complete study follow-up, as a measure of study feasibility

  2. Study completion and retention rate [ Time Frame: 3 months ]
    Change in patient-reported daily calcium intake, as a measure of intervention efficacy

  3. Intervention efficacy [ Time Frame: 3 months ]
    Change in patient-reported weekly exercise duration, as a measure of intervention efficacy


Secondary Outcome Measures :
  1. Clinical outcome [ Time Frame: 6 months ]
    Proportion of patients whose calcium, vitamin D intake, and exercise may be assessed from properly completed questionnaires

  2. Clinical outcome capture rate [ Time Frame: 6 months ]
    Patient and clinician satisfaction with clinical study on a ten-point scale

  3. Questionnaire, and Osteoporosis Health Belief Scale [ Time Frame: 3 months ]
    Change in patient knowledge and health benefits regarding osteoporosis, as determined with Facts on Osteoporosis Quiz - Revised, Men's Osteoporosis Knowledge

  4. BMD monitoring [ Time Frame: 6 months ]
    Proportion of enrolled patients having bone mineral density (BMD) tests performed within 6 months of ADT initiation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973673


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Canadian Association of Radiation Oncology
Investigators
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Principal Investigator: Shabbir Alibhai, MD UHN

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01973673     History of Changes
Other Study ID Numbers: 13-6050
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Health Network, Toronto:
prostate cancer
ADT
bone health

Additional relevant MeSH terms:
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Neoplasms