Spotting head and neck cancer symptoms in community pharmacies in Dundee and sharing information with GP practices
| ISRCTN | ISRCTN16102051 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16102051 |
| IRAS number | 316795 |
| Secondary identifying numbers | IRAS 316795, CPMS 56272 |
- Submission date
- 18/04/2023
- Registration date
- 26/04/2023
- Last edited
- 13/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Head and neck cancers are the fifth most common cancer in Scotland. Over the past 10 years, the number of new cases diagnosed each year has been increasing. There is low awareness of the symptoms of head and neck cancer among members of the public. Too many people are being diagnosed at later stages of disease when the cancer has had a chance to spread. This means that it is more difficult to treat. Earlier diagnosis improves survival.
Community pharmacy in Scotland is now the first port of call for people with minor illness. Symptoms in the early stages of serious disease, such as cancer, can be the same as those of less serious illnesses. Pharmacy teams can help to identify people with symptoms which could be a sign of a more serious illness. They can help to support people in going forward for review at their GP practice (or dentist) sooner.
We want to teach pharmacy staff to identify symptoms of head and neck cancer. We want them to be able to discuss these symptoms with people in a sensitive and reassuring way. Most people with these symptoms will not have cancer but their symptoms do need further review. We want to allow pharmacists to share patient details with GP practices to help patients to take the next step. We want to see if this is a service that members of the public and healthcare professionals will use and support.
Who can participate?
Patients over 18 years of age registered with a GP in Dundee City who go to a participating pharmacy with symptoms of concern
What does the study involve?
Patients who go to a participating pharmacy with symptoms linked to head and neck cancer will get some information to read. A pharmacist will have a discussion in a private consultation area to answer any questions they may have and ask them if they would like to take part in the study. The pharmacist will record some personal details and information about their symptoms. People who agree to take part, and give their permission, will have this information shared with their GP practice and with the study team. The pharmacist will tell them to contact their GP practice on the next working day to make an appointment. They will get a questionnaire to take away to complete.
The study team will contact patients who have given permission, to offer the chance to take part in an interview about the process.
The team will use patient details to get follow-up information from GP practices and from the hospital, where this applies. The team will keep information secure at all times.
GPs, or other practice clinicians, involved in reviewing patients, will get the chance to provide feedback by completing a questionnaire and doing an interview. This opportunity will also be given to participating pharmacists.
What are the possible benefits and risks of participating?
Most people with symptoms will not have cancer, but their symptoms do need further review. People may be upset by hearing that their symptoms may be a sign of serious illness. All concerns will be handled in a sensitive way by the pharmacist. People will be given information on support services available in their local area. Taking part will mean a longer consultation in the pharmacy but will allow the pharmacist to share details with the GP practice. This means the GP practice will have details ahead of the patient’s appointment. Taking part will also give people the opportunity to provide feedback on the process by completing a survey or doing an interview. This will give information about whether this type of service is possible to provide from pharmacies.
Patients who do not wish to take part can follow the advice given to them by pharmacy staff. They can contact their GP (or dentist) for a review of their symptoms without having their information shared in advance.
Where is the study run from?
The study is being sponsored by NHS Tayside. It will be run in some community pharmacies in Dundee (UK).
When is the study starting and how long is it expected to run for?
April 2022 to February 2024
Who is funding the study?
1. Scottish Government
2. Merck, Sharp and Dohme (MSD)
Who is the main contact?
Dr Andrew Radley, andrew.radley@nhs.scot
Contact information
Principal Investigator
Directorate of Public Health, NHS Tayside
Kings Cross, Clepington Road
Dundee
DD3 8EA
United Kingdom
 ORCID ID |
0000-0003-4772-2388 |
|---|---|
| Phone | +44 (0)1382 425681 |
| andrew.radley@nhs.scot |
Public, Scientific
North Cancer Alliance (NCA), NHS Scotland North, Summerfield House, 2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
| Phone | None provided |
|---|---|
| gram.noscancer@nhs.scot |
Study information
| Study design | Single-centre interventional non-randomized feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual, Pharmacy, Telephone |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Introduction of a Head and Neck Cancer General Practitioner communication pathway in Community Pharmacies in NHS Tayside (CP HNC GP Communication Pathway) |
| Study acronym | CP HNC GP Communication Pathway |
| Study objectives | To assess whether a community pharmacy head and neck cancer pathway is acceptable to service users and staff. |
| Ethics approval(s) | Approved 03/02/2023, London - Camberwell St Giles Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; + 44(0)207 104 8156; camberwellstgiles.rec@hra.nhs.uk), ref: 22/LO/0925 |
| Health condition(s) or problem(s) studied | Identification of possible head and neck cancer symptoms in community pharmacy |
| Intervention | Any eligible person presenting to a participating community pharmacy with symptoms of concern, linked to possible head and neck cancer, will be offered the opportunity to take part in the study. Following an initial consultation with pharmacy counter staff and the pharmacist they will be given a patient information leaflet and allowed time to read it. If they are happy to proceed with a consultation, the pharmacist will answer any questions they may have about the study and go through the informed consent form with them. This will take place in a private consultation area in the pharmacy. The pharmacist will then take the patient's details and complete the symptom assessment form by documenting details of their symptoms and some lifestyle information, along with patient details (name, address, CHI, phone number). The pharmacist will advise the patient to contact their GP practice on the next working day to request an appointment. They will provide them with an additional information leaflet, outlining next steps and providing information on available information resources and support. The pharmacist will then share details of the consultation with the patient's GP and the study team. GP practices, and secondary care services where applicable, will be contacted by the study team for follow-up information. Patients who have consented will be contacted by the project team for a follow-up questionnaire/interview. Participating GPs/clinicians and community pharmacists will also be offered the opportunity to complete a questionnaire/interview. |
| Intervention type | Other |
| Primary outcome measure | 1. Acceptability of the pathway is measured by: 1.1. Patient/public uptake at baseline 1.2. Patient/public feedback via questionnaire at 0-4 weeks and/or interview at 4 weeks 1.3. Pharmacy team feedback at week 24 (end of the recruitment period) 1.4. GP/practice staff feedback via questionnaire at week 4 and/or interview at week 24 |
| Secondary outcome measures | 1. Can a community pharmacy pathway identify people suspected of having head and neck cancer? Measured by number of completed community pharmacy head and neck cancer assessment tools at baseline. 2. To assess whether community pharmacists can accurately and reproducibly utilise the symptom assessment tool to enable confidence in their use by referral recipients. Measured by GP/practice staff feedback via questionnaire at week 4 and/or interview at week 24. 3. Do people advised by community pharmacy teams to seek further review, attend for further assessment of their symptoms? Measured by obtaining information on participant follow up with general practices at week 4. 4. Are people identified by this pathway referred onwards by primary care for further investigations? Measured via participant follow-up via national datasets using CHI number at week 24. |
| Overall study start date | 01/04/2022 |
| Completion date | 28/02/2024 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Any adult (age 18 years+), registered with a GP in Dundee City, who presents to one of the participating pharmacies with relevant symptoms as outlined in the protocol 2. Participating community pharmacists 3. GPs/clinicians who review patient participant(s) |
| Key exclusion criteria | 1. People without symptoms meeting study criteria 2. People not registered with a GP in Dundee City 2. Non-consenting individuals 3. Any person under the age of 18 years 4. Any person unable to participate in a consultation conducted in the English language |
| Date of first enrolment | 10/05/2023 |
| Date of final enrolment | 15/12/2023 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Clepington Road
Dundee
DD3 8EA
United Kingdom
Sponsor information
Hospital/treatment centre
Tayside Medical Science Centre
Ninewells Hospital & Medical School
Research & Development Office
Residency Block, Level 3
George Pirie Way
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | + 44 (0)1382 383877 |
|---|---|
| tascgovernance@dundee.ac.uk | |
| Website | http://www.nhstayside.scot.nhs.uk/index.htm |
"ROR" |
https://ror.org/000ywep40 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- MSD United Kingdom, Merck Sharp & Dohme, Merck Sharp & Dohme Corp., MSD
- Location
- United Kingdom
Government organisation / Local government
- Alternative name(s)
- The Scottish Government, Scottish Executive, Riaghaltas na h-Alba
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No |
Editorial Notes
13/03/2024: The public and scientific contact was changed.
27/10/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 31/10/2023 to 15/12/2023.
2. The overall study end date was changed from 31/12/2023 to 28/02/2024.
3. The intention to publish date was changed from 30/04/2025 to 30/04/2025.
20/09/2023: A link to the HRA research summary was added.
02/05/2023: Internal review.
21/04/2023: Trial's existence confirmed by London - Camberwell St Giles Research Ethics Committee.
