Condition category
Cancer
Date applied
10/08/2011
Date assigned
26/09/2011
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Mathew Kivell

ORCID ID

Contact details

University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10323

Study information

Scientific title

Determination of which Health Related Quality of Life (HRQoL) instrument is most preferred by patients with early and advanced thyroid cancer

Acronym

DeteQT

Study hypothesis

To determine which Health Related Quality of Life (HRQoL) instruments patients with early and advanced thyroid cancer find most helpful in facilitating communication of their health problems to their clinicians.

Ethics approval

The Black Country Research Ethics Committee, 18th March 2011, ref: 11/WM/0051

Study design

Phase III, randomised, observational, qualitative trial

Primary study design

Observational

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Head and neck cancer

Intervention

Patients are randomised to receive study instruments in varying order of presentation.
There are no treatment arms or drugs used as it is a quality of life questionnaire study. The patients will be approached in the clinic where the trial will be explained to them and if they are interested, they will sign the consent form and take the questionnaire to complete and send back to us.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Patient preference: identification of preferred quality of life instrument
The study only comprises of one questionnaire pack (as explained above). This includes four different quality of life questionnaires that the patient will complete and then answer a set of evaluation questions at the end. Once we receive them back, they are entered on a spreadsheet and then sent to a statistician

Secondary outcome measures

No secondary outcome measures

Overall trial start date

28/07/2011

Overall trial end date

12/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients 18 years old or over
2. Patients attending the thyroid or head neck cancer clinic who are:
2.1. Being treated or undergoing follow-up for differentiated (papillary or follicular) thyroid cancer or
2.2. Being investigated or treated for differentiated (papillary or follicular) thyroid cancer recurrence
Note: patients with high grade variants such as insular carcinoma or poorly differentiated carcinoma are eligible
3. Male or female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 466; UK Sample Size: 466

Participant exclusion criteria

1. Patients who do not sufficiently understand the English language and those with learning disabilities – as these are standardized and validated questionnaires which are in English
2. Patients who have medullary thyroid cancer or anaplastic thyroid cancer or lymphoma of the thyroid
3. Patients having a diagnostic hemithyroidectomy for possible thyroid cancer

Recruitment start date

28/07/2011

Recruitment end date

12/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHS Trust
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry & Warwickshire NHS Trust (UK)

Sponsor details

Medical Oncology
Clinical Sciences Research Unit
Clinical Sciences Building
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhcw.nhs.uk/

Funders

Funder type

Charity

Funder name

Macmillan Cancer Support (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

04/03/2016: No publications found, verifying study status with principal investigator