Contact information
Type
Scientific
Primary contact
Prof Hisahm Mehanna
ORCID ID
Contact details
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
+44 (0)24 76 96 5244
hisham.mehanna@uhcw.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HM22-0806
Study information
Scientific title
Determination of quality of life instrument most preferred by head and neck patients: a multicentre randomised controlled trial
Acronym
DETERMIN
Study hypothesis
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
Coventry Local Research Ethics Committee approved on the 13th December 2006 (ref: 06/Q2802/101)
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Can be found at http://www.inhanse.org
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
21/10/2008
Overall trial end date
29/10/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
600 returned questionnaires
Participant 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
Recruitment start date
21/10/2008
Recruitment end date
29/10/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
InHANE offices OPP ward 32
Coventry
CV2 2DX
United Kingdom
Sponsor information
Organisation
University Hospitals Coventry and Warwickshire NHS Trust (UK)
Sponsor details
c/o Ceri Jones
Research and Development Service Manager
University Office Suite
1st Floor Retunda
Clifford Bridge Road
Walsgrave
Coventry
CV6 4GJ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
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