The FOLLOW UP Study - a Natural Experiment Estimating the Clinical and Cost-effectiveness of Follow up Strategies After Curative Treatment for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Safety and clinical effectiveness defined by treatment for cancer recurrence
研究概览
简要总结
Over 20,000 patients a year in the UK get surgery or radiotherapy to cure their prostate cancer. These men then undergo regular check-ups to manage potential side effects and see if cancer recurs so it can be treated quickly. The organisation of these check-ups varies across the country as it is not known which approach is best. The four different established approaches are (i) check-ups performed in hospital outpatients by the same team that provided treatment; (ii) patients seen regularly by their GP with hospital referral as necessary; (iii) planned shared care between general practice and hospital follow up; or (iv) patients supported to provide checks on themselves (self-care) and reaching out to a doctor or a nurse when required. This study will compare these options to establish which is best for patients and makes the best use of the NHS resources.
详细描述
This is a pragmatic, prospective, propensity-matched, cohort study using routine data, with an embedded patient survey, economic evaluation, and qualitative and preference studies. Individual sites will be classified according to one of the four follow up strategies to compare outcomes in a natural experiment. Individual participants will be clustered within their treating hospital.
The main cohort for the study will be identified from the National Disease Registration Service Cancer Registry. Data on treatments, diagnoses, clinic attendances and other events that occur in secondary care from 3 years prior to diagnosis will be extracted from databases linked to the Cancer Registry including Cancer Pathway, Radiotherapy Dataset (RTDS), Systemic Anti-Cancer dataset (SACT) and Hospital Episode Statistics (HES). These datasets are referred to collectively as 'HES-linked data'. HES-linked data will be collected from 3 years prior to diagnosis, to enable analyses to be adjusted for patient medical history and pattern of health service use prior to diagnosis with prostate cancer, to the latest available date (expected to be 31 December 2026).
To identify the most clinically and cost-effective follow up strategy for patients, five interrelated work packages (WPs) will address specific objectives:
- WP1: Determine safety and clinical effectiveness of different follow up strategies
Stage 1: The utility of HES-linked data to study treatment for prostate cancer recurrence will be validated. It will be confirmed if databases contain the parameters required and are complete enough to robustly assess outcomes in secondary care including time to treatment for cancer recurrence and treatment for side-effects from primary treatment. Detailed statistical methods and computer code will be developed for determining whether follow up strategies are equivalent for treatment of recurrence, including methods for dealing with missing patients and treatment variables. A preliminary investigation of hospital adherence to stated follow up strategies will be conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All hospitals in England that provide radical prostatectomy or radical radiotherapy or focal therapy for prostate cancer and are identified by clinicians as receiving one of the four follow up strategies of interest will be eligible for inclusion in the study.
- •Individual patients satisfying the following criteria will be eligible for inclusion:
- •Having newly-diagnosed non-metastatic, clinically localised prostate cancer (ICD-10 code C61) in the Cancer Registry between 1 January 2018 and 31 December 2023;
- •Age 18 or over at diagnosis;
- •Completed primary curative treatment at an eligible hospital between 1 January 2019 and 31 December 2023 with either: radical radiotherapy +/- hormones, or radical prostatectomy with curative intent +/- lymphadenectomy, or focal therapy, in keeping with local practice;
- •Alive with no disease progression or metastasis 6 months after the date of completion of primary curative treatment.
排除标准
- •Men who are treated for metastatic cancer; or receiving palliative prostate cancer care;
- •Men who have opted out of their data being used as part of national routine data sets will be excluded (https://digital.nhs.uk/services/national-data-opt-out).
- •Recruitment to the survey component of the study will be limited to a sub-cohort of eligible participants that additionally meet the following criteria:
- •Have achieved between three to four and a half years of follow up (from completion of initial curative treatment) during the survey period.
研究组 & 干预措施
Primary care based follow up
After the initial hospital follow up, patients are discharged and exclusively managed by (non-specialist) general practices (GP or nurse led) in face-to-face or remote appointments, with hospital referral as necessary.
干预措施: Primary care based follow up (Other)
Planned shared care follow up
An ongoing combination of general practice and hospital management
干预措施: Planned shared care follow up (Other)
Hospital based follow up
Exclusively hospital led follow up, face-to-face or remotely by the specialist treating team.
干预措施: Hospital based follow up (Other)
Self-management
After initial hospital follow up, patients are discharged and managed remotely, with no scheduled review. A tracking system monitors prostate-specific antigen (PSA) tests performed in primary care or secondary care. Patients access support workers for remote consultation to discuss symptoms and request further specialist management as required.
干预措施: Self-management (Other)
结局指标
主要结局
Safety and clinical effectiveness defined by treatment for cancer recurrence
时间窗: At 3 years following end of initial radical surgery or radiotherapy or focal therapy
Probability of cancer recurrence treatment calculated from analysis of time to recurrence treatment, measured using Hospital Episode Statistics (HES)-linked cancer databases and patient survey that includes domains on cancer recurrence and treatment.
Estimate cost-effectiveness
时间窗: At 3 years, extrapolated over the remaining patient lifetime
Modelled cost-effectiveness reported as incremental cost per quality adjusted life year (QALY) gained at different points over patient lifetime from an NHS and personal social services perspective, measured using HES-linked databases and patient survey
次要结局
- Time to treatment for cancer recurrence provided in secondary care(Up to 7 complete years following end of initial radical surgery or radiotherapy or focal therapy)
- Metastases, cancer specific and overall survival(Up to 7 complete years following end of initial radical surgery or radiotherapy or focal therapy)
- Cancer recurrence treatments (salvage to cure vs palliative suggesting delayed diagnosis)(Up to 3 years following end of initial radical surgery or radiotherapy or focal therapy)
- Health related quality of life (HRQoL)(At 3 to 4.5 years following end of initial radical surgery or radiotherapy or focal therapy)
- Physical and psychological complications of treatment(At 3 years following end of initial radical surgery or radiotherapy or focal therapy)
- Prostate cancer core outcome set (COS)(At 3 years following end of initial radical surgery or radiotherapy or focal therapy)
- Patient experience and satisfaction(For the qualitative study: At enrolment for the qualitative study. For the DCE: At 3 to 4.5 years following end of initial radical surgery or radiotherapy or focal therapy)
- Adherence to follow up strategy(At 3 years following end of initial radical surgery or radiotherapy or focal therapy)
- Costs to health services(Measured at up to 7 years as well as at 3 years (for consistency with the key primary and secondary outcomes estimated in work package 1), following end of initial radical surgery or radiotherapy or focal therapy.)