Strategies to Improve Bone Health in Men on ADT

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043236
• Other study ID #: 13-6823
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: March 20, 2018
• Start date: November 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Healthy bones pamphlet
written educational material
• Bone Health Care Coordinator
The Bone Health Care Coordinator reviews educational materials with participant and facilitates ordering BMD.
• Letter to GP
The letter to the General Practitioner contains information about the study, recommendations for bone health, guidelines of Osteoporosis Canada, and the identical educational material that the participant received.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Cancer Society Research Institute (CCSRI)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient/physician satisfaction	Satisfaction will be measured with 5-point Likert scale ranging from poor to excellent and administered to patient, PC clinician, and General Physician	6 months
Primary	Adherence rate	Adherence to following through on recommendations/referrals related to study intervention and clinical outcomes.	6 months
Primary	Recruitment rate	Enrolled patients divided by approached eligible patients, and reasons for both ineligibility and refusal as documented in logs.	6 months
Primary	Retention rate	Proportion of patients available for follow-up outcome assessment.	6 months
Primary	BMD ordering	Rate of Bone Mineral Density ordering	6 months