Condition category
Cancer
Date applied
07/07/2016
Date assigned
07/07/2016
Last edited
03/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diagnosis of cancer during late stages of the disease and the resultant poor survival is more common in those from disadvantaged backgrounds, among certain ethnic groups, among those suffering from more other health conditions and among those first presenting with cancer to emergency medical services. Other possible factors which may make patients more likely to first present to healthcare services during the late stages of cancer include infrequent contact with their general practice, lack of engagement in cancer screening, and possibly a tendency to use acute or emergency services in preference to primary care. Previous initiatives (such as The Be Clear on Cancer Campaigns) took the form of television and radio advertisements and posters which were aimed at the public in general. For both financial and public health reasons, it is advantageous to target these programs towards those least likely to seek help for symptoms and those most at risk of advanced stage disease at diagnosis. If successful this might then lead to cancer diagnoses being made an earlier point when the cancer is at a more treatable stage. Targeted programs also provide the opportunity to tailor the programs so that it is most likely to appeal to the specific audience. The aim of this study is to find out whether a targeted program aimed at those at risk of presenting with late-stage cancer results in increased engagement with primary care.

Who can participate?
General Practices from three geographical clusters (London, Manchester and The North of England) have been invited to participate. From their patients they will select approximately seventy who are eligible. These are adults aged between 50 and 84 who have not seen their GP for a year and come from a disadvantaged background; missed their last cancer screening; have a history of using out of hours or emergency services rather than seeing a GP; missed their last appointment for long-term disease management; have low social support; or have ever smoked.

What does the study involve?
Selected patients are randomly allocated to one of two groups. Those in the first group receive normal care only. Those in the second group receive normal care and also receive a cancer awareness leaflet and letter by post. At the end of six months, patients' usual care teams record the number of and type of consultations attended by all selected patients during that six month period to compare whether there are any significant differences between the amount of patients going to see their GP in the two study groups.

What are the possible benefits and risks of participating?
Of those patients that are randomly assigned to receive the intervention some may already have symptomatic cancer but have not reported it to a health professional. As a result of the intervention these patients may arrange a consultation with their general practitioner. This in turn could lead to an earlier diagnosis of cancer and result in improved health outcome and a better chance of survival. Some other patients that are randomly assigned to receive the intervention may have symptoms that appear cancerous but are in fact benign or represent a different disease. This group may benefit from being reassured by their doctor that their symptoms are not a cause for concern or alternatively from appropriate treatment. Though both leaflet and letter are designed to re-engage members of hard to reach populations with primary care it is possible that it could generate anxiety in patients. In order to reduce these risks both the leaflet and letter have been written deliberately in a way that aims to minimise anxiety.

Where is the study run from?
Wolfson Institute of Preventive Medicine (UK)

When is the study starting and how long is it expected to run for?
June 2016 to December 2017

Who is funding the study?
Department of Health (UK)

Who is the main contact?
Dr Jean-Pierre Laake

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jean-Pierre Laake

ORCID ID

http://orcid.org/0000-0002-4406-268X

Contact details

Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

Protocol/serial number

31163

Study information

Scientific title

Writing to Encourage Late Consultation Outpatients to Make Engagement with their GP (WELCOME-GP)

Acronym

WELCOME-GP

Study hypothesis

The aim of this study is to determine the effect of a personal letter and cancer awareness leaflet (sent from one's general practitioner) on primary care consultations in twenty general practices among adults who rarely use primary care and who are at risk of late presentation of cancer.

Ethics approval

West of Scotland 3 Research Ethics Committee, 14/06/2016, ref: 16/WS/0110

Study design

Randomised; Both; Design type: Prevention, Process of Care, Education or Self-Management, Psychological & Behavioural, Case-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

If your practice is interested in participating please contact Dr Jean-Pierre Laake to request further information (GP information sheet)

Condition

Specialty: Primary Care, Primary sub-specialty: Cancer; UKCRC code/ Disease: Other/ General symptoms and signs

Intervention

1400 patients with no diagnosis of cancer but at risk or late presentation of cancer will be recruited to this randomised control trial from twenty general practices (seventy patients per practice) in England.

Within each practice the 70 recruited patients will be randomly assigned to either receive the intervention (study group) or not to receive the intervention (control group).

The intervention consists of a letter and leaflet posted to patients from their general practitioner. The letter and leaflet mention important cancer symptoms, encourage help-seeking for these symptoms at primary care, and give reassurance that consultation at primary care will not be considered a waste of the doctor’s time, or used as an opportunity for judgemental or coercive responses from the doctor.

After six months, patients' usual care teams will record the number of and type of consultations attended by all participants during that 6 month period. This data will then be sent to the research team in de-identified form.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Total number of appointments made in primary care within 6 months (183 days) of mailing of the intervention.

Secondary outcome measures

Total amount of appointments, investigations, referrals, treatments made within 6 months (183 days) of the mailing of the intervention.

Overall trial start date

01/02/2016

Overall trial end date

29/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subject must be registered with general practitioner
2. Age 50-84
3. Have not had primary care consultation in last 12 months
4 Satisfy at least two of the following:
4.1. Low socio-economic status
4.2. Missed last breast, bowel, cervical or abdominal aortic aneurysm screen
4.3. History of use of emergency or out of hours services instead of primary care
4.4. Missed last appointment for chronic disease monitoring/management
4.5. Low social support (only person registered with general practice at their address)
4.6. Smoker (ever)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1400; UK Sample Size: 1400

Participant exclusion criteria

1. Inclusion criteria not met
2. Already have a diagnosis of cancer
3. GP considers inappropriate in view of patient’s health, attitude or cognitive ability

Recruitment start date

11/07/2016

Recruitment end date

30/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Institute of Preventive Medicine
Policy research Unit Centre for Cancer Prevention Queen Mary University of London Charterhouse Square
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Joint research Management Office
5 Walden Street
London
E1 2EF
United Kingdom
+44 20 7882 7260
sponsorsrep@bartshealth.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Department of Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal before 31/12/2018 and on the department website. Additionally findings may be disseminated via conference presentations and internal reports.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/04/2017: Internal review.