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临床试验/NCT02043236
NCT02043236已完成不适用

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

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2013年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
2
主要终点
Recruitment rate

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Healthy bones pamphlet, letter to GP

Active Comparator

Strategy 1: Written educational material to patient and GP

干预措施: Healthy bones pamphlet (Behavioral)

Healthy bones pamphlet, letter to GP

Active Comparator

Strategy 1: Written educational material to patient and GP

干预措施: Letter to GP (Behavioral)

Healthy bones pamphlet, Bone Health Care Coordinator

Active Comparator

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

干预措施: Healthy bones pamphlet (Behavioral)

Healthy bones pamphlet, Bone Health Care Coordinator

Active Comparator

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

干预措施: Bone Health Care Coordinator (Behavioral)

Usual care

No Intervention

Control group gets usual care from their oncologist.

结局指标

主要结局

Recruitment rate

时间窗: 6 months

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

Patient/physician satisfaction

时间窗: 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

时间窗: 6 months

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

Retention rate

时间窗: 6 months

Proportion of patients available for follow-up outcome assessment.

BMD ordering

时间窗: 6 months

Rate of Bone Mineral Density ordering

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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