Introduction
The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
Research question
What is the most clinically and cost-effective follow-up protocol for people with prostate cancer who have had radical treatment?
- Intervention: Different follow up protocols. Examples include, but are not restricted to, supported self-management; shared care; survivorship; remote follow up, as suggested by NICE NG131.
- Patient group: Men with localised prostate cancer who have had radical treatment – to be defined and justified by applicants.
- Setting: Any setting
- Control: Interventions will be compared against each other.
- Study design: Applicants should define and justify the most appropriate study design to answer the research question.
- Important outcomes: Quality of life; overall survival; cost and resource use. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise.
- Other outcomes: Recurrence; management of physical and psychological problems arising due to complications of treatment, patient and carer satisfaction; cost-effectiveness of different follow-up protocols.
- Minimum duration of follow-up: To be defined and justified by applicants. Longer term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.
Rationale
Prostate cancer is the most common cancer in men, with increasing age, ethnicity and genetic predisposition being risk factors associated with the disease. In 2018, there were more than 11,000 deaths from prostate cancer in the UK.
In patients with intermediate or high risk localised prostate cancer, which has not spread to other parts of the body, radical treatment is offered with curative intent. Options include surgery to remove the entire prostate gland and lymph nodes, known as radical prostatectomy, or radical radiotherapy, also known as external beam radiotherapy. Radical radiotherapy can be given alone, or in combination with either hormone therapy, or with an internal radiation boost known as brachytherapy. All radical treatment options are associated with substantial risks of sexual, urinary or bowel dysfunction.
Following completion of radical treatment, patients are regularly followed up to allow for prompt detection of recurrence of disease. Follow up appointments also identify and manage side and late effects of prostate cancer and radical treatment, providing informational and psychological support, and relevant referrals to rehabilitation and other healthcare services.
Over recent years there have been new strategies that attempt to meet patient needs, and be clinically effective and cost-effective at the same time. For example, supported self-management, shared care, survivorship care plans, telephone-based follow-up and nurse-led follow-up as opposed to consultant-led.
Currently there is little guidance on the follow-up of patients after radical prostate cancer treatment, with different follow-up strategies implemented across different regions of the country and variations in how different trusts follow up patients. This led to NICE making a research recommendation in this area, with a particular focus on frequency and duration of follow-up, the type of examination or blood tests, and the roles of primary and secondary care in follow-up. Therefore, HTA is interested in commissioning research to define an optimal follow-up protocol for patients after radical prostate cancer treatment. Applications should be co-produced, demonstrating an equal partnership with service commissioners, providers and service users (or their advocates) in order to provide evidence and actionable findings of immediate utility to decision-makers and service users. Applicants may wish to consult the NIHR INVOLVE guidance on co-producing research.
Additional commissioning brief background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.
Making an application
If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.
Your application must be submitted on-line no later than 1pm on the 1 December 2021. Applications will be considered by the HTA Funding Committee at its meeting in January 2022.
Guidance notes and supporting information for HTA Programme applications are available by clicking the links.
Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2022.
Applications received electronically after 1300 hours on the due date will not be considered.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition. For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.
Should you have any queries please contact us by email: htacommissioning@nihr.ac.uk