A Pilot Study in the Transfer of Follow-up Reviews to the General Practitioner for Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires
研究概览
简要总结
This is a pilot study assessing the role of the general practitioner in performing follow-up reviews on men who have recently completed radical radiotherapy for prostate cancer. This will be measured primarily by assessing any changes to the patient's health-related quality of life which will be evaluated by the completion of questionnaires by the participant at each review visit. The study aims to confirm that patient outcome is identical, independent of whether follow-up is performed by a specialist or the patient's General Practitioner.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with a tumour T1-3 stage prostate cancer and have had radical radiotherapy with curative intent
- •Are between six and twelve months post-treatment completion
- •Have completed all treatment for prostate cancer (including hormonal deprivation therapy)
- •Have no evidence of metastatic disease
- •ECOG performance status of between 0-1
- •Remains willing to comply with study requirements
- •Has maintained contact with an individual general practitioner
排除标准
- •Persistent complications resulting from treatment defined as a minimum Grade 3 treatment toxicity
- •Unable to complete self-administered questionnaires
- •Are currently enrolled in a study that requires specialist follow-up
- •Life expectancy of less than 6 months
- •Surgery to remove the prostate
- •Evidence of biochemical failure
结局指标
主要结局
To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires
时间窗: QOL questionnaires will be asked to be completed at baseline, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months
次要结局
未报告次要终点