Plain English Summary
Background and study aims
Kidney tumours are increasingly detected in patients having investigations for unrelated symptoms. Currently, it is not possible to tell whether a tumour is not cancerous (benign) or is cancer by a scan, blood or urine test. Most patients diagnosed with a kidney tumour are offered surgery, but this carries serious risks. These include a 1 in 20 risk of a major complication requiring intervention such as injury to the bowel, liver or spleen and a 1 in 200 risk of death. A sample of tissue (biopsy) can usually tell whether a kidney tumour is benign or cancer. Some hospitals offer biopsies for small kidney tumours and it can change the way in which a patient may want to have their tumour treated. Instead of surgery, patients with benign tumours often choose to have monitoring or alternative treatments such as freezing the tumour which has fewer risks. Most side effects of biopsies (discomfort, bruising, and blood in the urine) get better without treatment. Nearly 6 in 10 kidney tumours are benign or are low grade (59%), meaning that they are unlikely to cause harm. This means that over half of patients can potentially avoid surgery if they have a biopsy.
Currently, access to biopsies is not equal across the UK. This study aims to find out what the barriers are and what action is required to offer a tumour biopsy service to all patients to help guide treatment decision and improve outcomes.
Who can participate?
Healthcare professionals involved in kidney tumour biopsy and patients who have or have had a kidney tumour (small renal mass)
What does the study involve?
We will interview doctors, commissioners, and patients to explore current service and viewpoints on the role of biopsy in the diagnosis of kidney lumps. We will include at least 5 hospitals to cover high, medium and low volume centres and get representation across the health delivery service.
What are the possible benefits and risks of participating?
This is an observational study and no additional risk or benefits to participants are anticipated.
Patient and public involvement:
We have conducted a pre-study online survey with the Kidney Cancer UK (KCUK) charity.
Our patient representatives for this study have been involved in drafting the study protocol and will represent patient views on the trial management committee.
Where is the study run from?
From University College London (UK) and 5 hospitals in the UK
When is the study starting and how long is it expected to run for?
From February 2020 to March 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Maxine Tran
rf.ifitb@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Ms Maxine Tran
ORCID ID
Contact details
UCL Department of Surgical Biotechnology
Division of Surgery and Interventional Science
9th Floor Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
+44 (0)20 7794 0500 ext. 32467
m.tran@ucl.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 45891, IRAS 275481
Study information
Scientific title
Identifying the facilitators and barriers to implementation of tumour biopsy in the diagnostic pathway for small renal masses
Acronym
Study hypothesis
1. What are the patient, public and professional preferences and views in relation to the usefulness of tumour biopsy in the management of small renal masses (SRM)?
2. What is the impact of renal tumour biopsy (RTB) on provision of care, in terms of clinical processes and outcomes?
3. What is the impact of RTB on patient experience, including choice and treatment decision making process?
4. What is the cost and cost-effectiveness of an RTB service?
5. What interventions (professional or organisational) would be required to enable implementation of RTB in the diagnostic pathway of small renal masses?
Ethics approval
Approved 04/08/2020, South Central - Berkshire Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8056; berkshire.rec@hra.nhs.uk), ref: 20/SC/0244
Study design
Observational qualitative
Primary study design
Observational
Secondary study design
Qualitative research
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Renal tumour
Intervention
Each participant could be involved in 1 or all 3 of the different method approaches. There will be no follow-up but participants will be able to contact the study team if they have further questions.
This study will employ an exploratory mixed-methods approach. Potential participants will be firstly invited to partake in individual interviews, from which the key factors that influence decision-making in relation to adopting Renal Tumour Biopsy (RTB) will be extracted. Once such factors are identified, a larger sample of potential participants will be asked to partake in a short questionnaire evaluating the wider prevalence of such factors, and the applicability and preferences for a range of potential solutions. Patients, members of their family, and the public will be invited from all the hospitals, KCUK website, and the UCL Biomedical research PPI network, to take part in focus group discussions hosted locally
Qualitative semi-structured interviews with clinicians, commissioners and patients will be used to capture detailed insights into personal experience and perceptions regarding RTB. Participants will be recruited from 5 hospitals ranging from high to low procedural volume.
Patient and public focus groups will explore common trends, perceptions and assumptions while providing diversity among participants. A questionnaire based on the influential facilitators and barriers elicited from the interviews and focus groups will be developed to assess the prevalence of such perceptions from a wider population. Roundtable workshops will include both patients and clinicians to discuss viewpoints and construct intervention strategies. Health economic analysis will be conducted and a decision-analytic model developed to estimate the cost-effectiveness of RTB adoption.
The study team will conduct an exploratory preliminary economic analysis to estimate the cost of RTB intervention adoption in the NHS. To this aim, data will be gathered from available evidence and from expert opinion (e.g. using the interviews with clinicians in the qualitative component of the study). The cost-utility measures will be the incremental cost per unit of change in the Quality Adjusted Life Years (QALY) gained.
A decision-analytic model (Markov model) will be developed to estimate the cost-effectiveness of performing RTB prior to surgery versus current common pathway (no RTB) to diagnose and manage SRMs. The model will estimate the lifetime costs (including active surveillance and robotic/laparoscopic/open surgery costs) and life expectancy of an average patient in both options. The model will be populated using data from published evidence on incidence, probabilities (e.g. false positive or negative tests, complications), NHS reference costs (e.g. the cost of the diagnostic test, surgery, follow up, complications, treatments for cancer), life expectancy and outcomes (e.g. utilities to calculate QALYs). Unit costs will be collected and assessed from the perspective of the NHS and personal social services via standard sources.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Prevalence of key factors that influence decision-making in relation to adopting Renal Tumour Biopsy (RTB), and the applicability and preferences for a range of potential solutions measured using interviews and questionnaires at a single timepoint. Interviews will be transcribed verbatim and coded using Computer Assisted Qualitative Data Analysis Software (i.e. NVivo). Braun and Clarke’s model of thematic analysis with a six-phase approach will be used to generate, review, and define themes within the interview transcripts. Data will be extracted from the online and paper questionnaires and entered into statistical analysis software (i.e. SPSS). The analysis will comprise of both descriptive data (mean and standard deviation/median and interquartile range as appropriate) and inferential statistics, where we will examine whether the prevalence of influences and preference for potential solutions differ between participant groups and according to demographic variables.
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
17/02/2020
Overall trial end date
01/03/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthcare professionals involved in the delivery of Renal Tumour Biopsy (RTB)
2. Patients with current or previous SRM
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/09/2020
Recruitment end date
03/03/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Broomfield Hospital
Court Road
Broomfield
Chelmsford
CM1 7ET
United Kingdom
Trial participating centre
The Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
Trial participating centre
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Trial participating centre
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Trial participating centre
Southmead Hospital
Southmead Rd
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
Joint Research Office
Gower Street
London
WC1E 6BT
United Kingdom
+44 (0)20 7794 0500
rf.randd@nhs.net
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Central Commissioning Facility (CCF); Grant Codes: NIHR200536
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
We will present the findings from this study at national and international clinical meetings. We will also communicate results to the kidney cancer community via social media and the KCUK and Royal Free Hospital websites.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/03/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN16455338_PROTOCOL_v1.0_17Feb2020.docx Uploaded 16/12/2020