Determination of quality of life instrument most preferred by head and neck patients

ISRCTN	ISRCTN69567857
DOI	https://doi.org/10.1186/ISRCTN69567857
Secondary identifying numbers	HM22-0806

Submission date: 09/07/2010
Registration date: 21/07/2010
Last edited: 18/12/2017

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

Not provided at time of registration

Study website

Contact information

Prof Hisahm Mehanna
Scientific

InHANE offices OPP ward 32
3rd Floor West Wing
University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Road
Walsgrave
Coventry
CV2 2DX
United Kingdom

Phone	+44 (0)24 76 96 5244
Email	hisham.mehanna@uhcw.nhs.uk

Study information

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Can be found at http://www.inhanse.org
Scientific title	Determination of quality of life instrument most preferred by head and neck patients: a multicentre randomised controlled trial
Study acronym	DETERMIN
Study objectives	This research project is to identify head and neck cancer patients most preferred questionnaire that will help them communicate and describe problems more effectively with their doctor. The null hypothesis is that the four questionnaires are equally useful in facilitating the communication of health concerns of both laryngeal and oral cancer patients to their health professionals.
Ethics approval(s)	Coventry Local Research Ethics Committee, 13/12/2006, ref: 06/Q2802/101
Health condition(s) or problem(s) studied	Early and advanced oral and laryngeal cancer
Intervention	Four questionnaires will be randomised in each pack. Packs are colour coded regarding early or advanced oral or laryngeal cancer. Patients are asked to complete study instrument in clinic while waiting to see their clinicians.
Intervention type	Other
Primary outcome measure	To determine which of four most commonly used head and neck health related quality of life instruments oral and laryngeal cancer patients find most helpful in facilitating communication of their health problems to their clinicians, measured in December 2010.
Secondary outcome measures	To determine the clinical significance of reported health related quality of life changes detected by the commonly used quality of life instruments in head and neck cancer, measured in December 2010.
Overall study start date	21/10/2008
Completion date	29/10/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	600 returned questionnaires
Key inclusion criteria	1. Patients aged greater than 18 years, either sex 2. Diagnosed with oral or laryngeal cancer 3. Attending the head and neck cancer clinic at least 3 months after completion of treatment
Key exclusion criteria	1. Patients who do not have oral or laryngeal cancer 2. Patients who have known recurrence of cancer 3. Patients who are undergoing palliative treatment
Date of first enrolment	21/10/2008
Date of final enrolment	29/10/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

InHANE offices OPP ward 32

Coventry
CV2 2DX
United Kingdom

Sponsor information

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

c/o Ceri Jones
Research and Development Service Manager
University Office Suite, 1st Floor Retunda
Clifford Bridge Road
Walsgrave
Coventry
CV6 4GJ
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

18/12/2017: No publications found in PubMed, verifying study status with principal investigator.