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Completed

NCT Number: NCT02043236

Strategies to Improve Bone Health in Men on ADT

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5T 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy bones pamphlet

Behavioral

written educational material

Other names: Building strong bones

Bone Health Care Coordinator

Behavioral

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

Other names: BHCC

Letter to GP

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.

Primary outcomes

  1. 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

  2. Adherence rate

    Time frame: 6 months

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

  3. Recruitment rate

    Time frame: 6 months

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

  4. Retention rate

    Time frame: 6 months

    Proportion of patients available for follow-up outcome assessment.

  5. BMD ordering

    Time frame: 6 months

    Rate of Bone Mineral Density ordering

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2014
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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