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Clinical Trials/NCT02043236
NCT02043236
Completed
Not Applicable

A Phase II RCT of Strategies to Improve Bone Health in Men on ADT

University Health Network, Toronto1 site in 1 country159 target enrollmentStarted: November 2013Last updated:
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Status
Completed
Enrollment
159
Locations
1
Primary Endpoint
Recruitment rate

Overview

Brief Summary

This is a phase II randomized controlled trial (RCT) of 2 strategies to improve bone health in men receiving androgen deprivation therapy (ADT).

Detailed Description

In this RCT the investigators are comparing 2 strategies to improve bone health to usual care. Strategy 1 - Patient and physician-specific written educational material. Pilot-tested customized written educational material about bone health for men on ADT will be used for this study. A customized letter will be prepared for the patient's primary care physician, with specific advice and recommendations for the targeted strategies. Both pamphlet and letter will include a list of additional resources. Strategy 2 - patient written material and a bone health care coordinator (BHCC). The same written patient material as in strategy 1 will be used, along with a BHCC who will follow the approach of successful studies and contact the patient by phone or arrange an in-person visit at the hospital if preferred by the patient. The BHCC will also encourage the patient to pursue a bone mineral density test (BMD) with their physician and adopt bone-appropriate diet, lifestyle, and supplement intake recommendations, and will follow up with the patient at least twice over the next 3 months to facilitate behavioural changes and BMD ordering. Counselling sessions are short, typically <15 min. The BHCC will also contact the patient's physician to help facilitate BMD testing. Time points in the study are baseline, 3-month follow up, and 6-month follow up.

Control group The control group consists of a wait-list control for 6 months, during which no specific recommendations or interventions will be made by the study team. Prostate Cancer (PC) clinicians can still provide usual care. At the end of 6 months, control group participants will be referred to the Osteoporosis Clinic at the University Health Network.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Commencing or planning to continue ADT for a least 6 months 50 years or older English fluency Life expectancy \>6 months

Exclusion Criteria

  • Prior Bone Mineral Density test within 2 years Prior visit at Osteoporosis Clinic within 2 years

Outcomes

Primary Outcomes

Recruitment rate

Time Frame: 6 months

Enrolled patients divided by approached eligible patients, and reasons for both ineligibility and refusal as documented in logs.

Patient/physician satisfaction

Time Frame: 6 months

Satisfaction will be measured with 5-point Likert scale ranging from poor to excellent and administered to patient, PC clinician, and General Physician

Adherence rate

Time Frame: 6 months

Adherence to following through on recommendations/referrals related to study intervention and clinical outcomes.

Retention rate

Time Frame: 6 months

Proportion of patients available for follow-up outcome assessment.

BMD ordering

Time Frame: 6 months

Rate of Bone Mineral Density ordering

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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