Quality of life in head and neck cancer follow-up clinics

ISRCTN	ISRCTN12861667
DOI	https://doi.org/10.1186/ISRCTN12861667
Secondary identifying numbers	N/A

Submission date: 09/08/2010
Registration date: 02/09/2010
Last edited: 17/05/2017

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

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-new-ways-supporting-people-after-treatment-cancers-mouth-throat-voice-box-quench

Contact information

Mr Hisham Mehanna
Scientific

Institute of Head and Neck Studies and Education (InHANSE)
Patient Research Interface Suite (opp Ward 32), 3rd Floor
University Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Phone	+44 (0)2476 96 5244
Email	HishamMehanna@aol.com

Study information

Study design	Randomised feasibility study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Quality of life driven consultations in head and neck cancer follow-up: a mixed methods feasibility study in nurse and doctor led clinics
Study acronym	QUENch
Study objectives	The study seeks to determine the feasibility of a large-scale randomised controlled trial to assess the effectiveness of a quality of life driven follow-up clinic in term of improvement in patients' health-related quality of life.
Ethics approval(s)	Coventry Research Ethics Committee, 06/11/2009
Health condition(s) or problem(s) studied	Head and neck cancer
Intervention	The intervention involves the use of a validated quality of life questionnaire - the FACT HN - on a tablet touch screen computer in both nurse-led and doctor-led clinics. The impact of the questionnaire will be assessed in terms of clinician-patient communication, patient self-report measures of the experience of the consultation and by qualitative interview. Patients will attend one baseline consultation and 4 - 6 weeks later one intervention consultation. All patients will be sent a quality of life questionnaire six weeks after the intervention consultation.
Intervention type	Other
Primary outcome measure	Percentage of patients showing improvement in the Consultation and Relational Skills Questionnaire (CARE), measured at baseline consultation and intervention consultation
Secondary outcome measures	1. Patient Enablement Instrument (PEI), measured at baseline consultation and intervention consultation 2. Perceived Involvement in Care Scale (PICS) for patients, measured at baseline consultation and intervention consultation 3. European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), measured at 4 - 6 weeks following the intervention 4. European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Specific Questionnaire (EORTC QLQ-HN35), measured at 4 - 6 weeks following the intervention
Overall study start date	09/07/2010
Completion date	11/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	44
Key inclusion criteria	1. Patients with early or advanced oral/oropharyngeal and laryngeal cancer who have completed curative treatment 1 - 12 months previously 2. Attend head and neck follow-up clinic 3. Male and female patients age 18 years or over 4. The ability to communicate in and read English 5. The ability to give informed consent
Key exclusion criteria	1. Patients undergoing treatment for palliation 2. Patients with cancers that are not laryngeal or oral/oropharyngeal
Date of first enrolment	09/07/2010
Date of final enrolment	11/04/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Head and Neck Studies and Education (InHANSE)

Coventry
CV2 2DX
United Kingdom

Sponsor information

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

Research and Development Department
First Floor Rotunda
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom

Phone	+44 2476 966198
Email	Ceri.Jones@uhcw.nhs.uk
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

17/05/2017: No publications found in PubMed, verifying study status with principal investigator