Condition category
Cancer
Date applied
22/11/2010
Date assigned
03/03/2011
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Morris

ORCID ID

Contact details

University of Cambridge
General Practice & Primary Care Research Unit
University Forvie Site
Robinson Way
Cambridge
CB2 0SR
United Kingdom
-
hcm29@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9223

Study information

Scientific title

Factors influencing patient appraisal of symptoms and associations with cancer diagnosis: an observational cohort study with an interview component

Acronym

SYMPTOM Study

Study hypothesis

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

Cambridgeshire 3 REC, 14/09/2010, ref: 10/H0306/50

Study design

Multicentre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Diagnostic

Patient 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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

22/11/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 7000; UK sample size: 7000

Participant 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

Recruitment start date

22/11/2010

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Cambridge
Cambridge
CB2 0SR
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes