The ThinkCancer! Feasibility Study

March 29, 2021 updated by: Bangor University

The ThinkCancer! Intervention: Protocol for a Feasibility Study Incorporating a Randomised Pilot Trial With an Embedded Process and Economic Evaluation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bangor, United Kingdom
        • Recruiting
        • Betsi Cadwaldr University Health Board
      • Blaenau Gwent, United Kingdom
        • Recruiting
        • Aneurin Bevan University Health Board
      • Camarthenshire, United Kingdom
        • Recruiting
        • Hywel Dda University Health Board
      • Cardiff, United Kingdom
        • Recruiting
        • Cardiff and Vale University Health Board
      • Cwm Taf, United Kingdom
        • Recruiting
        • Cwm Taf Morgannwg University Health Board
      • Powys, United Kingdom
        • Recruiting
        • Powys Teaching Health Board
      • Swansea, United Kingdom
        • Recruiting
        • Swansea Bay University Health Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any practices in Wales are eligible for inclusion.

Exclusion Criteria:

  • As we intend to include a broad group of general medical practices, there are no formal exclusion criteria.

As determining feasibility is the main objective of this study, the eligibility criteria remain broad in order to allow for inclusion of a range of practices, which will aid the intervention refinement and allow for a better understanding on what is feasible in all types of practices and why some practices may not take part.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual practice
Experimental: Intervention
Receives educational workshop
Other: ThinkCancer workshop
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of a future definitive trial
Time Frame: From date of initial expression of interest to participate to end of follow up period (13 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Two Week Wait referral rate
Time Frame: Six months pre-randomisation and six months post-randomisation
Number of two week rate referrals made in a given time period, multiplied by 100000 and divided by the practice list size
Six months pre-randomisation and six months post-randomisation
Primary Care Interval
Time Frame: Six months pre-randomisation and six months post-randomisation
The time between the date of first presentation and the date of referral
Six months pre-randomisation and six months post-randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangor University

Collaborators

North Wales Organisation for Randomised Trials in Health
Cancer Research Wales

Investigators

  • Principal Investigator: Clare Wilkinson, Bangor University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • UWalesBangor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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