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 |
| Protocol serial number | SPON 327-06 |
| Sponsor | Cardiff University (UK) |
| Funder | Cancer Research UK (UK) (ref: C8350/A8205) |
- 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
Scientific
North Wales Clinical School
Cardiff University
Gwenfro Unit 5
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom
| Phone | +44 (0)1978 316268 |
|---|---|
| nealrd@cardiff.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
To compare the two groups in terms of overall completion rates using an intention to treat analysis |
| Key secondary outcome measure(s) |
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). |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
LL13 7YP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 24/01/2022 | No | Yes |
Editorial Notes
24/01/2022: A link to plain English results was added.
