Condition category
Cancer
Date applied
09/08/2010
Date assigned
02/09/2010
Last edited
08/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Hisham Mehanna

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

QUENch

Study hypothesis

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

Coventry Research Ethics Committee, 06/11/2009

Study design

Randomised feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

09/07/2010

Overall trial end date

11/04/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

44

Participant exclusion criteria

1. Patients undergoing treatment for palliation
2. Patients with cancers that are not laryngeal or oral/oropharyngeal

Recruitment start date

09/07/2010

Recruitment end date

11/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Head and Neck Studies and Education (InHANSE)
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry and Warwickshire NHS Trust (UK)

Sponsor details

Research and Development Department
First Floor Rotunda
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Ceri.Jones@uhcw.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.uhcw.nhs.uk/

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

Publication citations

Additional files

Editorial Notes