Determination of quality of life instrument most preferred by head and neck patients
| ISRCTN | ISRCTN69567857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69567857 |
| Protocol serial number | HM22-0806 |
| Sponsor | University Hospitals Coventry and Warwickshire NHS Trust (UK) |
| Funder | Macmillan Cancer Support (UK) |
- Submission date
- 09/07/2010
- Registration date
- 21/07/2010
- Last edited
- 18/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
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
| Phone | +44 (0)24 76 96 5244 |
|---|---|
| hisham.mehanna@uhcw.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Determination of quality of life instrument most preferred by head and neck patients: a multicentre randomised controlled trial |
| Study acronym | DETERMIN |
| Study objectives | 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(s) | Coventry Local Research Ethics Committee, 13/12/2006, ref: 06/Q2802/101 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 29/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 600 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/10/2008 |
| Date of final enrolment | 29/10/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CV2 2DX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/12/2017: No publications found in PubMed, verifying study status with principal investigator.
