Condition category
Cancer
Date applied
30/07/2008
Date assigned
18/09/2008
Last edited
09/01/2014
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 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 measures

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

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

http://www.cardiff.ac.uk

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

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24387663

Publication citations

  1. 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.

Additional files

Editorial Notes