Condition category
Cancer
Date applied
23/09/2019
Date assigned
08/10/2019
Last edited
08/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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 March 2021

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

Who is the main contact?
Victoria Gallyer
grrand@ndorms.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Toby Smith

ORCID ID

Contact details

University of Oxford
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
+44 (0)1865227668
toby.smith@ndorms.ox.ac.uk

Type

Scientific

Additional contact

Mrs Victoria Gallyer

ORCID ID

Contact details

The Centre for Rehabilitation Research (RRIO)
Nuffield Department of Orthopaedics
Rheumatology and Musculoskeletal Sciences (NDORMS)
University of Oxford
Botnar Research Centre
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
+44 (0)1865 737905
victoria.gallyer@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS: 43309

Study information

Scientific title

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

Acronym

GRRAND-F

Study hypothesis

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

Not provided at time of registration

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management, Physical, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Drug names

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 trial start date

25/07/2018

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 72; UK Sample Size: 72

Participant 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

Recruitment start date

01/11/2019

Recruitment end date

01/11/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Trust HQ, PO Box 9551 Queen Elizabeth Medical Centre Edgbaston
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Oxford University Hospitals NHS Foundation Trust

Sponsor details

c/o Shahista Hussain
Joint Research Office
Second Floor
OUH Cowley Unipart House Business Centre
Garsington Road
Oxford
OX4 2PG
United Kingdom
+44 (0)1865 572233
ouh.sponsorship@ouh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/08/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/09/2019: Trial's existence confirmed by the NIHR.