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ISRCTN
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ISRCTN12861667
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ClinicalTrials.gov identifier
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Public title
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Quality of life in head and neck cancer follow up clinics
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Scientific title
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Quality of life driven consultations in head and neck cancer follow-up: a mixed methods feasibility study in nurse and doctor led clinics
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Acronym
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QUENch
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-new-ways-supporting-people-after-treatment-cancers-mouth-throat-voice-box-quench
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Ethics approval
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Coventry Research Ethics Committee approved on the 6th November 2009
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Study design
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Randomised feasibility study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Head and neck cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Patients undergoing treatment for palliation
2. Patients with cancers that are not laryngeal or oral/oropharyngeal
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Anticipated start date
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09/07/2010
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Anticipated end date
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11/04/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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44
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Interventions
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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.
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Primary outcome measure(s)
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Percentage of patients showing improvement in the Consultation and Relational Skills Questionnaire (CARE), measured at baseline consultation and intervention consultation
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Secondary outcome measure(s)
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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
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Sources of funding
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Macmillan Cancer Support (UK)
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Trial website
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Publications
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Contact name
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Mr
Hisham
Mehanna
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Address
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Institute of Head and Neck Studies and Education (InHANSE)
Patient Research Interface Suite (opp Ward 32), 3rd Floor
University Hospital
Clifford Bridge Road
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City/town
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Coventry
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Zip/Postcode
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CV2 2DX
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Country
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United Kingdom
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Tel
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+44 (0)2476 96 5244
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Fax
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+44 (0)2476 96 6915
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Email
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HishamMehanna@aol.com
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Sponsor
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University Hospitals Coventry and Warwickshire NHS Trust (UK)
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Address
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Research and Development Department
First Floor Rotunda
Clifford Bridge Road
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City/town
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Coventry
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Zip/Postcode
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CV2 2DX
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Country
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United Kingdom
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Email
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Ceri.Jones@uhcw.nhs.uk
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Sponsor website:
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http://www.uhcw.nhs.uk/
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Date applied
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09/08/2010
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Last edited
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01/09/2011
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Date ISRCTN assigned
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02/09/2010
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