Determination of the Quality of Life Instrument that is most preferred by patients with thyroid cancer

ISRCTN	ISRCTN29843533
DOI	https://doi.org/10.1186/ISRCTN29843533
Secondary identifying numbers	10323

Submission date: 10/08/2011
Registration date: 26/09/2011
Last edited: 30/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-to-see-which-qol-questionnaire-people-with-thyroid-cancer-find-most-helpful-deteqt

Contact information

Mr Mathew Kivell
Scientific

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

Study information

Study design	Phase III, randomised, observational, qualitative trial
Primary study design	Observational
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Determination of which Health Related Quality of Life (HRQoL) instrument is most preferred by patients with early and advanced thyroid cancer
Study acronym	DeteQT
Study objectives	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(s)	The Black Country Research Ethics Committee, 18th March 2011, ref: 11/WM/0051
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	28/07/2011
Completion date	12/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 466; UK Sample Size: 466
Key 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
Key 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
Date of first enrolment	28/07/2011
Date of final enrolment	12/07/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospitals Coventry and Warwickshire NHS Trust

Coventry
CV2 2DX
United Kingdom

Sponsor information

University Hospitals Coventry & Warwickshire NHS Trust (UK)
Hospital/treatment centre

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

Website	http://www.uhcw.nhs.uk/
"ROR"	https://ror.org/025n38288

Funders

Funder type

Charity

Macmillan Cancer Support (UK)

No information available

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

Editorial Notes

30/04/2018: No publications found, verifying study status with principal investigator.
04/03/2016: No publications found, verifying study status with principal investigator