Diagnosis: Earlier Looking At Your Symptoms - development of a patient-centred tool to measure diagnostic delays

ISRCTN	ISRCTN04475865
DOI	https://doi.org/10.1186/ISRCTN04475865
Secondary identifying numbers	SPON 327-06

Submission date: 30/07/2008
Registration date: 18/09/2008
Last edited: 24/01/2022

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 Richard Neal
Scientific

North Wales Clinical School
Cardiff University
Gwenfro Unit 5
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom

Phone	+44 (0)1978 316268
Email	nealrd@cardiff.ac.uk

Study information

Study design	Multi-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Diagnosis: Earlier Looking At Your Symptoms - development of a patient-centred tool to measure diagnostic delays
Study acronym	DELAYS2
Study objectives	This pilot study aims to determine the acceptability (to patients and research nurses), feasibility and validity of a tool to measure patient and primary delays in cancer. In particular this work will: 1. Pilot the recruitment of patients with a recent and established diagnosis of one of seven specific cancers (or groups of cancers) and the administration of the tool by research nurses 2. Assess non-response bias 3. Assess and seek ways to minimize the level of anxiety that may be raised as part of the data collection process 4. Assess completion rates 5. Compare the response to the tool being administered by a research nurse with self-completion facilitated by a research nurse
Ethics approval(s)	North East Wales Local Research Ethics Committee. Date of approval: 03/04/2007 (ref: 07/WNo03/1)
Health condition(s) or problem(s) studied	Cancer (breast, colorectal, lung, gynaecological, urological, upper GI, haematological)
Intervention	The participants will be randomly allocated to self-completion vs researcher administration of a tool to measure symptoms prior to a diagnosis. The tool is a document with open and closed questions about symptoms patients have had and how long they have had them for.
Intervention type	Other
Primary outcome measure	To compare the two groups in terms of overall completion rates using an intention to treat analysis
Secondary outcome measures	A comparison will be made between the two modes of the average anxiety levels. This will be assessed after diagnosis as soon as possible, using the Six-item State-Trait Anxiety Inventory (STAI).
Overall study start date	01/09/2008
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300
Key inclusion criteria	1. Both males and females, age 18+ (no upper limit) 2. Cancer patients with new primary diagnoses of one or groups of the following seven cancers: breast, colorectal, lung, gynaecological, urological, upper gastrointestinal (GI), haematological 3. Patients who are aware of the diagnosis of cancer and confirmed as eligible by Clinical Team
Key exclusion criteria	1. Patients close to death 2. Patients without mental capacity or linguistic capacity to complete the questionnaire
Date of first enrolment	01/09/2008
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

North Wales Clinical School

Wrexham
LL13 7YP
United Kingdom

Sponsor information

Cardiff University (UK)
University/education

Research and Commercial Division
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom

Phone	+44 (0)2920 875834
Email	davieskp2@cardiff.ac.uk
Website	http://www.cardiff.ac.uk
"ROR"	https://ror.org/03kk7td41

Funders

Funder type

Charity

Cancer Research UK (UK) (ref: C8350/A8205)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/01/2014		Yes	No
Plain English results			24/01/2022	No	Yes

Editorial Notes

24/01/2022: A link to plain English results was added.