The ThinkCancer! Feasibility Study

NCT04823559 | Unknown DMC

• 1 other identifier: UWalesBangor
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

Background Wales, like other UK countries, has relatively poor cancer outcomes. Late diagnosis and a slow referral process are major contributors. General practitioners (GPs) and other care providers working in primary care are often faced with patients presenting with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic uncertainty by ensuring patients with vague symptoms are appropriately monitored. The ThinkCancer! Workshop is an educational behaviour change intervention aimed at the whole general medical practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan. This study aims to assess the feasibility of the ThinkCancer! Intervention for a future definitive randomised controlled trial, in terms of recruitment, randomisation, retention, acceptability, adherence and barriers to the intervention. Methods The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and economic evaluation. Twenty-three to 30 general medical practices will be recruited across Wales, randomised in a ratio of 2:1 of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator, and will be adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will also collect Primary Care Interval (PCI), Two Week Wait (2WW) referral rate, conversion rate and detection rate at baseline and six months post-randomisation. Participant feedback, researcher reflective notes and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation. Discussion This study will allow us to test and further develop a novel evidenced-based complex intervention aimed at general practice teams to expedite the diagnosis of cancer in primary care. The results from this feasibility study will inform the future design of a full-scale definitive phase III trial.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of a future definitive trial

  Number of practices approached, interested in participating, consented and randomised, retention of recruited practices, ability to collect data

  From date of initial expression of interest to participate to end of follow up period (13 months)

Secondary Outcomes (2)

• Two Week Wait referral rate

  Six months pre-randomisation and six months post-randomisation

• Primary Care Interval

  Six months pre-randomisation and six months post-randomisation

Study Arms (2)

Usual practice

NO INTERVENTION

Usual practice

Intervention

EXPERIMENTAL

Receives educational workshop

Other: ThinkCancer workshop

Interventions

ThinkCancer workshop OTHER

The proposed intervention, the ThinkCancer! Workshop, is practice-based and consists of themed sessions for both clinical and non-clinical staff, the co-production of a Cancer Safety Netting Plan (CSNP) and the appointment of a Cancer Safety Netting Champion (CSNC). The workshop aims to raise awareness and increase knowledge around current cancer diagnosis guidance and will be delivered over half a day during GP protected time in the form of face-to-face educational sessions. Sessions will consist of a series of interactive activities exploring existing processes within practices and developing plans for change to implement each component.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Bangor University: lead
• Cancer Research Wales: collaborator
• North Wales Organisation for Randomised Trials in Health: collaborator

Study Sites (7)

Betsi Cadwaldr University Health Board

Bangor, United Kingdom

RECRUITING

Aneurin Bevan University Health Board

Blaenau Gwent, United Kingdom

RECRUITING

Hywel Dda University Health Board

Camarthenshire, United Kingdom

RECRUITING

Cardiff and Vale University Health Board

Cardiff, United Kingdom

RECRUITING

Cwm Taf Morgannwg University Health Board

Cwm Taf, United Kingdom

RECRUITING

Powys Teaching Health Board

Powys, United Kingdom

RECRUITING

Swansea Bay University Health Board

Swansea, United Kingdom

RECRUITING

Related Publications (1)

• Disbeschl S, Surgey A, Roberts JL, Hendry A, Lewis R, Goulden N, Hoare Z, Williams N, Anthony BF, Edwards RT, Law RJ, Hiscock J, Carson-Stevens A, Neal RD, Wilkinson C. Protocol for a feasibility study incorporating a randomised pilot trial with an embedded process evaluation and feasibility economic analysis of ThinkCancer!: a primary care intervention to expedite cancer diagnosis in Wales. Pilot Feasibility Stud. 2021 Apr 21;7(1):100. doi: 10.1186/s40814-021-00834-y.

  PMID: 33883033 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Clare Wilkinson

  Bangor University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica L Roberts, BSc, PhD

CONTACT

01248 383516; j.l.roberts@bangor.ac.uk

Stefanie Disbeschl

CONTACT

01248 383507; stefanie.disbeschl@bangor.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: April 1, 2021
• Study Start: February 5, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)