Getting Recovery Right After Neck Dissection (GRRAND-F): Feasibility study to design a pragmatic randomised controlled trial

ISRCTN	ISRCTN11979997
DOI	https://doi.org/10.1186/ISRCTN11979997
IRAS number	268845
Secondary identifying numbers	CPMS: 43309, IRAS: 268845

Submission date: 23/09/2019
Registration date: 08/10/2019
Last edited: 07/06/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Head and neck cancer (HNC) affects over 9000 in the UK annually. People affected and surviving HNC in the UK are now younger and more active than previous generations. The treatment pathway for HNC is complex due to the varied anatomical sites of disease and the needs of the patient. With the advent of chemo-radiotherapy as a curative treatment, fewer patients require a neck dissection (ND). However, even with this approach, up to 20% of patients require an ND due to residual disease. After surgery ND is associated with both early and late complications, occurring in 50-100% of patients. Early complications can include shoulder pain and infection. Late complications include shoulder movement dysfunction, speech, swallowing and musculoskeletal problems such as cervical contracture and muscle wastage and can continue to be present over 5 years. Psychosocial complications are also highly prevalent after surgery, predominantly fatigue, anxiety, depression, sleep disturbance and social isolation. Shoulder dysfunction and psychosocial complications are strongly associated with reduced return to work, with up to 50% of patients ceasing working due to shoulder disability alone. Currently, there is no national standard best practice for the effective management of shoulder rehabilitation and associated complications following HNC. The researchers' study development work and feedback from Patient and Public (PPI) representatives have shown that physiotherapy practice varies across the UK. It suggests that rehabilitation in the form of physiotherapy is not routinely available to patients with HNC, either in an in-patient or outpatient settings. What is offered is not evidence-based, and when available, it is not focused and targets acute respiratory care, range of motion exercises for the neck and shoulder, and advice on positioning of the upper limb and shoulder girdle. Outpatient treatment is minimal, and most commonly reactive, driven by patient request. In addition to investigating the feasibility of an enhanced rehabilitation intervention following HNC ND, this study will also standardise usual care through a (control group) recovery framework and patient leaflet.

Who can participate?
Patients aged 18 and above being treated for HNC in whom an ND is part of their care

What does the study involve?
Participants are randomly allocated to one of two groups. Both groups receive inpatient physiotherapy and receive a booklet of advice and exercises on discharge. Those allocated to the intervention group also attend up to 6 sessions of outpatient physiotherapy over 6 months. Participants are asked to complete exercise diaries and outcome data at the start of the study and after 6 months and 12 months (if their appointment is before February 2021), clinical data are also collected at these times. Both groups will have optional consent for interviews. Of those who consent 15 participants are contacted to arrange face-to-face interviews to help increase our understanding of people’s experiences of being involved in this study

What are the possible benefits and risks of participating?
The study will find out if it is possible to do a large trial investigating better physiotherapy treatments for people who have had an operation (neck dissection) for head and neck cancer treatment. The results of that study would then be able to tell physiotherapists if the GRRAND-F intervention is effective or not. 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. 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?
1. The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS)
2. University of Oxford Botnar Research Centre

When is the study starting and how long is it expected to run for?
July 2018 to April 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Alana Morris
grrand@ndorms.ox.ac.uk

Study website

Contact information

Dr Toby Smith
Scientific

University of Oxford
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom

Phone	+44 (0)1865227668
Email	toby.smith@ndorms.ox.ac.uk

Ms Alana Morris
Scientific

Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom

Phone	+44 (0)1865 737928
Email	octrutrialshub@ndorms.ox.ac.uk

Study information

Study design	Randomized; Interventional; Design type: Treatment, Education or Self-Management, Physical, Rehabilitation
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Getting Recovery Right After Neck Dissection (GRRAND-F): Feasibility study to design a pragmatic randomised controlled trial
Study acronym	GRRAND-F
Study objectives	Head and neck cancer (HNC) is becoming more common in the UK. The main treatments for HNC include surgery, radiotherapy, and chemotherapy. Treatment outcomes for HNC are improving, however, surgical side-effects can be significant, including swallowing problems, fatigue, anxiety, and shoulder problems. About half of people cannot return to work following their surgery and we do not know what the best way is to help people best recover. This study will see if a rehabilitation treatment programme is acceptable for patients who have been discharged from hospital after surgery for HNC. The programme has been designed by physiotherapists and patients who have had HNC surgery.
Ethics approval(s)	Approved 29/10/2019, Oxford B Research Ethics Committee (Whitefriars Level 3, Block B, Lewin's Mead, Bristol, BS1 2NT; +44 (0)207 104 8253; nrescommittee.southcentral-oxfordb@nhs.net), ref: 19/SC/0457
Health condition(s) or problem(s) studied	Head and neck cancer
Intervention	A mixed-methods feasibility study investigating the design of a randomised controlled trial to test the clinical and cost-effectiveness of an individualised, rehabilitation programme compared to usual care in patients undergoing a neck dissection for head and neck cancer. The study will be undertaken in secondary care head and neck cancer surgical centres across England to provide geographical and demographic variability to assess the feasibility study objectives. Patients will be approached at their initial surgical consultation where the decision to undergo neck dissection will be made. Those who express an interest in the study will be approached a second time e.g. at their pre-operative assessment appointment (approximately two weeks prior to surgery) where they will be asked whether they wish to enrol onto the study. Consent will be sought at this appointment and baseline data collected. When the patient returns to the hospital for the operation, for those who have given consent, the post-operative surgical notes will be reviewed to verify eligibility. Consented participants who are still eligible will then be randomised. As part of routine NHS care, all participants will be assessed by a physiotherapist within the first 24 hours postoperatively. All will receive routine ward-based physiotherapy including respiratory care, positioning and advice on walking and activities of daily living, in addition to advice on general exercises to start neck and shoulder exercises. This will be supplemented by a leaflet developed as part of this trial. Those randomised to the control group will receive no further physiotherapy unless determined by the ward physiotherapist or a member of the surgical team at the time of discharge or thereafter. If they independently seek further physiotherapy, they will be asked to document when, where and for how long their physiotherapy lasted. Participants randomised to this group will receive no further out-patient (post-discharge from the hospital) physiotherapy but will be advised to continue with the exercises provided pre-hospital discharge, and to remain as generally physically active as possible. This mirrors routine physiotherapy care for this population. Those randomised to the experimental group will receive the GRRAND intervention. This consists of usual care (as described above) PLUS an individualised physiotherapy intervention (up to six sessions) provided by a GRRAND-trained physiotherapist. The intervention will be individually tailored to each participant’s clinical presentation and rehabilitation need. The components will include range of motion exercises, progressive resistance exercises, education and advice on positioning, oral health and pain management, exercise adherence, return to work and normal activities, scar management and education addressing fatigue, anxiety and sleep hygiene. The intervention consists of up to six sessions of physiotherapy, of 45 minutes each (except the first session which is 60 minutes). All sessions are to be completed within a maximum of 6 months post-hospital discharge. Participants recruited will be enrolled for a minimum of six months post-randomisation to a maximum of 12 months post-randomisation depending on when the participant is recruited in the lifetime of the study. Only those randomised during the early part of the study will receive a 12-month questionnaire due to the availability of funding.
Intervention type	Other
Primary outcome measure	Recruitment and retention rates from study participants across sites, measured using overall study recruitment numbers, screening logs, consent forms and logs of data collection forms completed at 6 months and 12 months (for those participants who reach this timepoint within the study)
Secondary outcome measures	Clinical outcome measures are primarily collected to calculate the sample size for the definitive trial. Outcome data to be collected at each of the data collection intervals (at baseline, 6 and 12 months unless stated otherwise) are listed below: 1. Shoulder pain and function measured using the well-validated Shoulder Pain and Disability Index (SPADI) 2. Pain measured using the SPADI 5-item Pain Sub-scale and using a numerical rating scale (0-10) 3. Pain medication details and usage – relating to head, neck and shoulder 4. Chemotherapy and radiotherapy treatment provision 5. Function measured using the SPADI 8-item Disability Sub-scale 6. Health-related quality of life measured using the EQ-5D-5L score and the EORTC questionnaires (C30 (core)) and H&N43 (head and neck specific) 7. Health resource use questionnaire (collection of health resources for computation of direct medical, direct nonmedical and indirect costs); additional out-of-pocket expenses; and work absence (number of sickness days) 8. Adverse events: such as prolonged delayed onset muscle soreness, swelling and wound irritation 9. Physical performance measures including shoulder and neck range of motion and grip strength measured at the 6-month and 12-month assessment by an appropriately trained and delegated member of the research team The study will also conduct qualitative interviews of participants and physiotherapist to wider experiences, perceptions, feasibility and acceptability of the study design from a patient and physiotherapist perspective. This will also aim to determine the potential risks of intervention contamination.
Overall study start date	25/07/2018
Completion date	30/04/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 72; UK Sample Size: 72
Total final enrolment	36
Key inclusion criteria	1. Men and women aged 18 years and above 2. Patients being treated for HNC in whom an ND is part of their care 3. Willing and able to provide informed consent 4. Able to understand written English 5. Willing to attend the physiotherapy outpatient department if randomised to the experimental intervention arm 6. Patients who remain eligible post-operatively when reviewed prior to randomisation
Key exclusion criteria	1. If treatment is palliative (expected survival six months or less) 2. Those with a pre-existing, long-term neurological disease affecting the shoulder e.g. hemiplegia
Date of first enrolment	01/11/2019
Date of final enrolment	31/10/2021

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Oxford University Hospitals NHS Foundation Trust

John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust

Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Sponsor information

Oxford University Hospitals NHS Foundation Trust
Hospital/treatment centre

c/o Shahista Hussain
Joint Research Office
Second Floor
OUH Cowley Unipart House Business Centre
Garsington Road
Oxford
OX4 2PG
England
United Kingdom

Phone	+44 (0)1865 572233
Email	ouh.sponsorship@ouh.nhs.uk
"ROR"	https://ror.org/03h2bh287

Funders

Funder type

Government

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-1217-20031

No information available

Results and Publications

Intention to publish date	31/12/2022
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	1. Peer reviewed scientific journals 2. Conference presentation 3. Publication on website 4. The researchers will also be working with their PPI contributors in case there are any further dissemination routes that should be pursued
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		21/06/2021	24/06/2021	Yes	No
Other publications	Embedded qualitative interview study	14/11/2022	15/11/2022	Yes	No
Results article	results	16/03/2023	04/04/2023	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

07/06/2024: The following changes were made to the study record:
1. Contact details updated.
2. The study participating centres were updated to remove University Hospitals Birmingham NHS Foundation Trust and add Norfolk and Norwich University Hospitals.
04/04/2023: Publication reference and total final enrolment added.
15/11/2022: Publication reference added.
20/07/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2021 to 31/10/2021.
2. The overall trial end date was changed from 31/01/2022 to 30/04/2022.
3. The intention to publish date was changed from 30/04/2022 to 31/12/2022.
24/06/2021: Publication reference added.
16/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2020 to 30/06/2021.
2. The overall trial end date was changed from 31/03/2021 to 31/01/2022.
3. The intention to publish date was changed from 31/08/2021 to 30/04/2022.
4. Recruitment to this study is no longer paused.
5. Trial website added.
03/02/2021: Contact details updated.
21/04/2020: Due to current public health guidance, recruitment for this study has been paused.
04/11/2019: The following changes have been made:
1. The ethics approval has been updated.
2. The IRAS number has been added.
23/09/2019: Trial's existence confirmed by the NIHR.