Condition category
Cancer
Date applied
09/07/2020
Date assigned
10/07/2020
Last edited
07/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The study aims to find out what people think about using pharmacists to refer people with lung symptoms for a chest x-ray to check for lung cancer. We will see if this could be something that could be used in the future, and what we can do to improve it.

Who can participate?
Members of the public attending pharmacies with some lung symptoms e.g. a cough, who are smokers or ex-smokers.

What does the study involve?
The pharmacist will ask you some questions about your health. If they feel you need a chest x-ray they will send you for one. You will be referred to the hospital for a chest x-ray. The hospital will send you a letter or ring you to let you know your results. You might be asked to go to the hospital for further tests if needed. The pharmacist will give you a short questionnaire to fill in when you get home. Some people will be invited to take part in an interview and the researcher will be asking questions to get a better idea of what you thought about the service, why you went to your pharmacist for advice and how we can help other people to access this help in the future.

What are the possible benefits and risks of participating?
The results of the research will help us to understand what services can make the most difference to patients. This can help other patients like you in the future. It may also mean that you can get the appropriate treatment for your symptoms.

The symptoms that you have described to your pharmacist mean that a chest x-ray is recommended in guidance from the National Institute for Health and Care Clinical Excellence (NICE). We would recommend you have a chest x-ray even if you chose not to participate in the study. A chest x-ray is a form of ionising radiation that allows images to be made of your body. Exposure to large amounts of ionising radiation can carry risks to the body, for example, it can cause cell damage that may, over many years and decades, turn cancerous. The amount of radiation that a chest x-ray will expose you to is very small and is the same amount of exposure as 2 days natural radiation from the environment. This has less than 1 in 1 million chance of causing cancer.

Where is the study run from?
There are 16 community pharmacies participating in the study, all based in the Llanelli or Burry Port area of Hywel Dda University Health Board.

When is the study starting and how long is it expected to run for?
May 2018 to August 2020

Who is funding the study?
Health and Care Research Wales (UK)

Who is the main contact?
Dr Rachel Gemine
rachel.e.gemine@wales.nhs.uk
Mrs Sarah Rees
sarah.rees7@wales.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Sarah Rees

ORCID ID

Contact details

Beacon Centre for Enterprise
Llanelli
SA14 6DS
United Kingdom
+44 (0)1554 899018
sarah.rees7@wales.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 231842

Study information

Scientific title

Pharmacy referral for Lung cancer Symptoms: a feasibility study to assess the role of pharmacists in lung cancer diagnosis compared to current pathways

Acronym

PLUS1

Study hypothesis

To monitor numbers of patients suitable for referral/willingness to be referred for chest x-ray by community pharmacies and subsequent lung cancer diagnosis rates.

Ethics approval

Approved 23/11/2018, Wales REC6 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB; +44 (0)1874 615950; Wales.REC6@wales.nhs.uk) ref: 18/WA/0215

Study design

Observational mixed methods

Primary study design

Observational

Secondary study design

Case series

Trial setting

Community

Trial type

Diagnostic

Patient information sheet

Condition

Lung cancer

Intervention

Members of the public presenting at community pharmacies with symptoms of lung cancer will be offered a consultation with the pharmacist and if required, direct referral to the local hospital for a chest x-ray. Participants will also be asked to complete a questionnaire and invited to a qualitative interview with a researcher, following their x-ray.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Number of patients referred via the pathway measured using case report forms at the end of the study
2. Number of patients referred with a lung cancer diagnosis measured using patient records at the end of the study

Secondary outcome measures

Assessed using a novel questionnaire and interview at a single time point:
1. Acceptability of the pathway to patients and healthcare professionals
2. Perceived impact on pharmacy workload and radiology referrals
3. Patient and professional views and experiences of consulting the pharmacist

Overall trial start date

31/05/2018

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Individuals over the age of 40, who are current or ex-smokers with a history of 10 or more smoking pack-years, and have had 1 or more of the following, for more than three weeks:
1.1. Coughing up blood
1.2. High pitched audible wheeze
1.3. Neck vein engorgement/facial swelling
1.4. Cough
1.5. Chest and/or shoulder pain
1.6. Unexplained weight loss
1.7. Shortness of breath
1.8. Hoarse voice
1.9. Finger clubbing
1.10. Swollen nodes in the head or neck
2. Community pharmacists and respiratory physicians involved in patient care

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

228

Participant exclusion criteria

1. Unable or unwilling to provide written informed consent
2. Patients who have a diagnosed cognitive impairment will be excluded from the evaluation/ follow up element of the study
3. WHO performance status 4

Recruitment start date

01/05/2019

Recruitment end date

31/03/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Prince Philip Hospital
Hywel Dda University Health Board Bryngwyn Mawr Dafen
Llanelli
SA14 8QF
United Kingdom

Sponsor information

Organisation

Hywel Dda University Health Board

Sponsor details

2nd Floor
Sealyham Block
Withybush Hospital
Haverfordwest
SA61 2PZ
United Kingdom
+44 (0)1437773813
chris.tattersall@wales.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health and Care Research Wales

Alternative name(s)

Ymchwil Iechyd a Gofal Cymru

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results of the study will be disseminated via peer reviewed scientific journals, internal reports, conference presentations and website publications.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

31/08/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

07/08/2020: The following changes were made to the trial record: 1. The participant information sheet was uploaded as an additional file. 2. Uploaded protocol (not peer reviewed) Version 2.0 23 August 2018. 10/07/2020: Trial’s existence confirmed by Health and Care Research Wales.