Strategies to Improve Bone Health in Men on ADT

University Health Network, Toronto

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: Letter to GP; Behavioral: Bone Health Care Coordinator; Behavioral: Healthy bones pamphlet

Study type: Interventional

Funder types: Other

Identifiers

NCT02043236

13-6823

Details and patient eligibility

About

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

Full 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.

Enrollment: 159 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 3 patient groups

Healthy bones pamphlet, letter to GP

Active Comparator group

Description:

Strategy 1: Written educational material to patient and GP

Treatment:

Behavioral: Healthy bones pamphlet

Behavioral: Letter to GP

Healthy bones pamphlet, Bone Health Care Coordinator

Active Comparator group

Description:

Strategy 2: Written educational material to patient and counseling from a Bone Health Care Coordinator

Treatment:

Behavioral: Healthy bones pamphlet

Behavioral: Bone Health Care Coordinator

Usual care

No Intervention group

Description:

Control group gets usual care from their oncologist.