Condition category
Cancer
Date applied
09/07/2010
Date assigned
21/07/2010
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.inhanse.org

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

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