Strategies to Improve Bone Health in Men on ADT

NCT ID: NCT02043236

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy bones pamphlet, letter to GP

Strategy 1: Written educational material to patient and GP

Group Type: ACTIVE_COMPARATOR

Healthy bones pamphlet

Intervention Type: BEHAVIORAL

written educational material

Letter to GP

Intervention Type: BEHAVIORAL

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.

Healthy bones pamphlet, Bone Health Care Coordinator

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

Group Type: ACTIVE_COMPARATOR

Healthy bones pamphlet

Intervention Type: BEHAVIORAL

written educational material

Bone Health Care Coordinator

Intervention Type: BEHAVIORAL

The Bone Health Care Coordinator reviews educational materials with participant and facilitates ordering BMD.

Usual care

Control group gets usual care from their oncologist.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Healthy bones pamphlet

written educational material

Intervention Type: BEHAVIORAL

Bone Health Care Coordinator

The Bone Health Care Coordinator reviews educational materials with participant and facilitates ordering BMD.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Building strong bones; BHCC

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Cancer Society (CCS)

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shabbir Alibhai, MD

Role: PRINCIPAL_INVESTIGATOR

UHN

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

Alibhai SMH, Breunis H, Timilshina N, Hamidi MS, Cheung AM, Tomlinson GA, Manokumar T, Samadi O, Sandoval J, Durbano S, Warde P, Jones JM. Improving bone health in men with prostate cancer receiving androgen deprivation therapy: Results of a randomized phase 2 trial. Cancer. 2018 Mar 15;124(6):1132-1140. doi: 10.1002/cncr.31171. Epub 2017 Dec 6.

Reference Type: DERIVED

PMID: 29211305 (View on PubMed)

Other Identifiers

13-6823

Identifier Type: -

Identifier Source: org_study_id