A Phase II RCT of Strategies to Improve Bone Health in Men on ADT
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
- 否
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
Strategy 1: Written educational material to patient and GP
干预措施: Healthy bones pamphlet (Behavioral)
Healthy bones pamphlet, letter to GP
Strategy 1: Written educational material to patient and GP
干预措施: Letter to GP (Behavioral)
Healthy bones pamphlet, Bone Health Care Coordinator
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
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
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
