Contact information
Type
Scientific
Primary contact
Dr Richard Neal
ORCID ID
Contact details
North Wales Clinical School
Cardiff University
Gwenfro Unit 5
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom
+44 (0)1978 316268
nealrd@cardiff.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SPON 327-06
Study information
Scientific title
Acronym
DELAYS2
Study hypothesis
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
North East Wales Local Research Ethics Committee. Date of approval: 03/04/2007 (ref: 07/WNo03/1)
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/09/2008
Overall trial end date
30/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Patients close to death
2. Patients without mental capacity or linguistic capacity to complete the questionnaire
Recruitment start date
01/09/2008
Recruitment end date
30/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Wales Clinical School
Wrexham
LL13 7YP
United Kingdom
Sponsor information
Organisation
Cardiff University (UK)
Sponsor details
Research and Commercial Division
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
+44 (0)2920 875834
davieskp2@cardiff.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK) (ref: C8350/A8205)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24387663
Publication citations
-
Results
Neal RD, Nafees S, Pasterfield D, Hood K, Hendry M, Gollins S, Makin M, Stuart N, Turner J, Carter B, Wilkinson C, Williams N, Robling M, Patient-reported measurement of time to diagnosis in cancer: development of the Cancer Symptom Interval Measure (C-SIM) and randomised controlled trial of method of delivery., BMC Health Serv Res, 2014, 14, 3, doi: 10.1186/1472-6963-14-3.