The SYMPTOM Study: factors influencing patient appraisal of symptoms

ISRCTN	ISRCTN47493581
DOI	https://doi.org/10.1186/ISRCTN47493581
Secondary identifying numbers	9223

Submission date: 22/11/2010
Registration date: 03/03/2011
Last edited: 17/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Helen Morris
Scientific

University of Cambridge
General Practice & Primary Care Research Unit
University Forvie Site
Robinson Way
Cambridge
CB2 0SR
United Kingdom

Email	hcm29@medschl.cam.ac.uk

Study information

Study design	Multicentre observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	GP practice
Study type	Diagnostic
Participant information sheet	Can be found at http://www.medschl.cam.ac.uk/gppcru/userfiles/ProjectDocs/Symptom/the%20symptom%20study%20pis%20version%203%2015sept10%20adh.pdf
Scientific title	Factors influencing patient appraisal of symptoms and associations with cancer diagnosis: an observational cohort study with an interview component
Study acronym	SYMPTOM
Study objectives	The DISCOVERY Programme has the overall aim of optimising the diagnosis of symptomatic cancer, and comprises 6 projects which contribute to three themes, addressing the issues at patient level (Theme 1, The SYMPTOM Study), primary care level (Theme 2), and the primary/secondary care interface (Theme 3). The SYMPTOM Study will identify features of later presentation of cancer to inform consumer awareness and general practice based interventions. It is a cohort study with an interview component, to characterise factors affecting symptom appraisal and associations with cancer in people referred with symptoms suspicious of lung, colorectal or pancreatic cancer. The objectives are: 1. To identify symptoms associated with later presentation 2. To identify symptoms associated with later stage at diagnosis 3. To identify other patient factors (e.g. age, gender, comorbidities, living alone) associated with later presentation or later stage at diagnosis 4. To understand the way in which symptoms suggestive of these cancers are recognised, interpreted and acted upon by patients Patients referred by their GP to hospital for further investigation of symptoms suggestive of lung, colorectal or pancreatic cancer will be invited to participate in the study. They will be asked to complete a questionnaire about their symptoms and their decision to consult their doctor about them. We will conduct in-depth, face-to-face interviews with some participants to better understand their views and experiences of their symptoms.
Ethics approval(s)	Cambridgeshire 3 REC, 14/09/2010, ref: 10/H0306/50
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network, Primary Care Research Network for England; Subtopic: Colorectal Cancer, Upper Gastro-Intestinal Cancer, Lung Cancer, Not Assigned; Disease: Colon, Lung (small cell), Lung (non-small cell), Pancreas, Rectum, All Diseases
Intervention	1. Participant interviews: in-depth semi-structured interviews with approximately 120 participants 2. Questionnaires: questionnaires for self-completion will be mailed to the participants Follow-up length: 0 months Study entry: registration only
Intervention type	Other
Primary outcome measure	Identification of patient and symptom factors associated with later presentation to health care, measured at 24 months (end of study)
Secondary outcome measures	1. Association of delay in presentation of symptoms with stage at diagnosis, measured at 24 months (end of study) 2. Understanding patient interpretation of symptoms and the language used by patients, measured at 24 months (end of study)
Overall study start date	22/11/2010
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 7000; UK sample size: 7000
Key inclusion criteria	Respiratory symptoms: 1. Aged over 40 years, either sex 2. Persistent or changed cough 3. Change of breathlessness 4. Chest pain (intermittent, worse when breathing or coughing) 5. Coughing up blood-stained phlegm (haemoptysis) 6. GP expressed concern about possibility of cancer Gastrointestinal symptoms: 1. Aged over 40 years, either sex 2. Change in bowel habit 3. Blood in stool 4. Abdominal pain with weight loss 5. Abdominal mass 6. Anaemia 7. GP expressed concern about possibility of cancer
Key exclusion criteria	Respiratory symptoms: 1. Review of established diagnosis where there is no cancer concern 2. Previous lung or ENT cancer Gastrointestinal symptoms: 1. Review of established diagnosis where there is no cancer concern 2. Previous gastrointestinal (GI) cancer 3. Chronic alcohol abuse (to exclude chronic pancreatitis) 4. Known infective diarrhoea (e.g., after recent foreign travel) 5. Abdominal pain in the absence of weight loss 6. Dyspepsia 7. Upper abdominal pain where dyspepsia is a significant symptom
Date of first enrolment	22/11/2010
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Cambridge

Cambridge
CB2 0SR
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge (UK)
Hospital/treatment centre

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Website	http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request until end of 2019.

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	11/12/2014	Yes	No
Results article	results	31/03/2015	Yes	No
Results article	results	09/10/2015	Yes	No
Results article	results	23/08/2016	Yes	No
Results article	results	01/12/2016	Yes	No
Results article	results	03/09/2017	Yes	No

Editorial Notes

17/01/2019: Publication references and IPD sharing statement added.
19/12/2017: No publications found in PubMed, verifying study status with principal investigator.