Getting recovery from head and neck cancer right after neck dissection
| ISRCTN | ISRCTN13855775 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13855775 |
| IRAS number | 333106 |
| Secondary identifying numbers | NIHR158902, SOC.20 23-24, CPMS 58043 |
- Submission date
- 18/12/2024
- Registration date
- 20/12/2024
- Last edited
- 16/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Head and neck cancer affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year over 12,000 people get head and neck cancer. It is the 8th most common form of cancer. Over recent years many more people, particularly young people, have developed head and neck cancers. Many of these cancers are removed surgically. Some people also need radiotherapy or chemotherapy. Treatments are improving and better at getting rid of these cancers. Neck dissection is a common operation for this. This involves an operation to remove the lymph nodes in the neck. Many people having neck dissection have poor shoulder and neck movements, pain, fatigue and low mood afterwards. Only half ever return to work. The best way to help people recover after this operation is unknown. The study team want to find out whether physiotherapy treatment after neck dissection for these cancers helps people recover better. A small (pilot) study followed 36 people who had a neck dissection as part of their treatment. Half were offered extra physiotherapy after surgery. The other half had normal NHS care without extra physiotherapy. The extra physiotherapy treatment included neck and shoulder exercises, education on how to manage pain and relaxation techniques to help cope with fatigue and anxiety. This physiotherapy treatment was known as the GRRAND programme. The study was a success, with people who took part appreciating the extra treatment. The team now want to find out in a bigger study if the GRRAND programme helps patients and if it is good value for money for the NHS.
Who can participate?
Adult patients aged 18 years and older who are having a neck dissection operation as part of their treatment for head and neck cancer can participate at least 12 NHS hospitals in the UK
What does the study involve?
The study will randomly allocate participants to either: (1) usual NHS care which is physiotherapy assessment in a hospital and a leaflet providing advice on basic exercises; OR (2) usual NHS care PLUS the GRRAND physiotherapy programme.
The study will compare how well people recover, and their overall quality of life after a year in each group and work out how much each treatment costs. This will confirm whether the GRRAND programme helps people recover better after neck dissection for head and cancers, and if it is good value for the NHS. The team will also interview patient participants and physiotherapists delivering the GRRAND programme to understand how it may work in the NHS.
What are the possible benefits and risks of participating?
The study will find out if offering a personalised physiotherapy programme after neck dissection for people with head and neck cancer is clinically beneficial and cost-effective to the NHS. There may not be any benefit in taking part in this study, research like this helps to continually improve the treatments and care provided to all patients now and in the future by collecting information on what may or may not help.
There are only minimal risks involved in this research. There is a possible risk of feeling a little sore after exercising as part of the physiotherapy rehabilitation. However, participants will be guided by their physiotherapist and will be able to seek their advice on managing any soreness and activities will be modified if needed.
Where is the study run from?
The study is being run from the Warwick Clinical Trials Unit at the University of Warwick. The qualitative study and process evaluation component of the study is being led by the University of Exeter.
When is the study starting and how long is it expected to run for?
September 2024 to March 2028
Who is funding the study?
National Institute for Health Research (NIHR) (UK) as part of the Health Technology Assessment (HTA) Programme funding stream.
Who is the main contact?
GRRAND email address: grrand@warwick.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-physiotherapy-after-surgery-for-head-and-neck-cancer-grrand
Contact information
Principal Investigator
Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Giblet Hill Road
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0003-1673-2954 |
|---|---|
| toby.o.smith@warwick.ac.uk |
Principal Investigator
Nuffield Department of Surgical Sciences
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
| ORCID ID |
0000-0002-8152-816X |
|---|---|
| stuart.winter@nds.ox.ac.uk |
Public, Scientific
Warwick Medical School
Coventry
CV4 7AL
United Kingdom
| grrand@warwick.ac.uk |
Study information
| Study design | Two-arm multi-centre pragmatic randomized controlled trial with internal pilot integrated health economic evaluation and process evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Hospital, Medical and other records |
| Study type | Treatment |
| Participant information sheet | Not avaliable in web format, please use contact details to request a participant information sheet. |
| Scientific title | Getting Recovery Right After Neck Dissection for head and neck cancer (GRRAND) |
| Study acronym | GRRAND |
| Study objectives | What is the clinical and cost-effectiveness of a personalised, physiotherapy-led, rehabilitation intervention (the GRRAND programme) compared to best practice NHS, post-discharge care for adults undergoing neck dissection for head and neck cancer? |
| Ethics approval(s) |
Approved 11/11/2024, London - Brent NHS Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048128, (0)207 104 8117, (0)2071048131; brent.rec@hra.nhs.uk), ref: 24/LO/0722 |
| Health condition(s) or problem(s) studied | Rehabilitation after neck dissection for head and neck cancer |
| Intervention | 1. Control Group (Best Practice NHS Post-Discharge Care) Treatment Given: Routine NHS care including ward-based physiotherapy (respiratory care, positioning, walking, activities of daily living, neck and shoulder exercises) supplemented by a leaflet. Total Duration of Treatment: Initial physiotherapy within the first 24 hours postoperatively, with no further physiotherapy unless deemed necessary by the ward physiotherapist or surgical team. Follow-Up: Participants will be advised to continue exercises provided pre-hospital discharge and remain physically active. Follow-up assessments at baseline, six weeks, six months, and 12 months post-randomisation. Randomisation Process: Participants will be randomised after verifying eligibility post-surgery. The specific method of randomisation (e.g., online tool, sealed envelope) is not detailed in the provided information. 2. Experimental Group (GRRAND Programme) Treatment Given: Routine NHS care as described for the control group, plus a personalised physiotherapy intervention (up to six, one hour sessions) provided by a GRRAND-trained physiotherapist. The intervention includes range of motion exercises, progressive resistance exercises, education and advice on positioning, oral health, pain management, exercise adherence, return to work and normal activities, scar management, and education on fatigue, anxiety, and sleep hygiene. Total Duration of Treatment: Up to six sessions of physiotherapy, each lasting 60 minutes. Follow-Up: Similar follow-up assessments as the control group at baseline, six weeks, six months, and 12 months post-randomisation. Randomisation Process: Same as the control group, with randomisation occurring after verifying eligibility post-surgery. |
| Intervention type | Behavioural |
| Primary outcome measure | Shoulder pain and function measured using the participant-reported Shoulder Pain and Disability Index (SPADI) questionnaire (total score) at 12 months |
| Secondary outcome measures | The following secondary outcome measures are assessed at 6 weeks, 3, 6 and 12 months unless specified otherwise: 1. Shoulder pain and function measured using the SPADI total score (secondary outcomes at 6 weeks and 6 months only) 2. Pain, function and disability subdomains measured using the individual SPADI domains 3. Health-related quality of life measured using the EQ-5D-5L*; EORTC cancer-specific questionnaires (C30(core); H&N35 (head and neck-specific 4. Mental wellbeing measured using the Short Warwick-Edinburgh Mental Wellbeing Scale 5. Exercise adherence measured using the Exercise Adherence Rating Scale at 6 weeks only 6. Adverse events including surgical complications* 7. Health resource use measured using a questionnaire* (*3-month assessment for adverse events, EQ-5D-5L and health utilisation questionnaire only) The study will also conduct a process evaluation including qualitative interviews of participants and physiotherapists to wider experiences, perceptions, reach and implementation of the trial and treatments from a patient and physiotherapist perspective. |
| Overall study start date | 01/09/2024 |
| Completion date | 28/02/2028 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 390 |
| Key inclusion criteria | 1. People aged 18 years or over 2. Diagnosis of HNC with requirement for a neck dissection as part of their treatment with curative intent. Including those undergoing completion neck dissection following positive sentinel node biopsy or open neck node biopsy. 3. Able to attend out-patient physiotherapy appointments. 4. Provide informed consent. |
| Key exclusion criteria | 1. People for whom intensive post-discharge physiotherapy is expected (e.g., scapula/scapula tip and/or latissimus dorsi free flaps or components thereof). This constitutes 3-5% of the neck dissection population and clinical equipoise regarding the role of physiotherapy is less evident. 2. People with a pre-existing, long-term disease affecting the shoulder, e.g., hemiplegia. 3. People who had prior neck dissection surgery on the affected side. People who had a previous neck dissection on the affected side (except sentinel lymph node biopsy requiring completion neck dissection) 4. People undergoing Lymph Node Biopsy or Sentinel Lymph Node Biopsy only. 5. Previous entry in the present trial. 6. Unable to adhere to trial processes. |
| Date of first enrolment | 30/04/2025 |
| Date of final enrolment | 01/08/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Norwich
NR4 7UY
United Kingdom
Oxford
OX3 9DU
United Kingdom
Longfleet Road
Poole
BH15 2JB
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Fulham Road
London
SW3 6JJ
United Kingdom
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Westcliff-on-sea
SS0 0RY
United Kingdom
Taunton
TA1 5DA
United Kingdom
Sponsor information
University/education
Research and Impact Services
University House
Kirby Corner Road
Coventry
CV4 8UW
England
United Kingdom
| Phone | +44 (0)2476575733 |
|---|---|
| sponsorship@warwick.ac.uk | |
| Website | https://www.warwick.ac.uk |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planning is in place to share the results of this trial through numerous streams including: 1. Peer-reviewed scientific journals 2. Conference presentations 3. Publication on website 4. The researchers will also be working with the GRRAND team's PPIE contributors to develop public-facing materials and to share results across the community. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
16/07/2025: Cancer Research UK plain English summary of protocol link added.
11/03/2025: The recruitment start date was changed from 14/03/2025 to 30/04/2025.
11/02/2025: The recruitment start date was changed from 28/02/2025 to 14/03/2025.
18/12/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
