GRRAND-F: Getting Recovery Right After Neck Dissection-Feasibility
Research type
Research Study
Full title
Getting Recovery Right After Neck Dissection (GRRAND-F): Feasibility study to design a pragmatic randomised controlled trial.
IRAS ID
268845
Contact name
Stuart Winter
Contact email
Sponsor organisation
R&D Department at OUHNHSFT
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Summary of Research
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. \n\nThis 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. \n\nPatients who have had surgery for HNC, and who have agreed to participate in the study, will get either usual care, or usual care PLUS the study’s new rehabilitation treatment programme. A computer will decide by chance which treatment regime they will get. \nUsual care is treatment and information an NHS patient would usually get after they have had surgery for HNC. This will include in-patient physiotherapy and an advice leaflet on basic exercise and self-care following surgery; and may include referral for out-patient physiotherapy when they are discharged. The study treatment programme we are testing has extra rehabilitation treatment on top of this usual care. This will give patients up to 6 physiotherapy appointments over 6 months, which will include exercises and advice for managing pain, and coping with fatigue and common side-effects of HNC surgery. \n\nTo decide if the programme is acceptable to patients, we will look at how many of the people who are told about the study decide to join it; how long they stay in the study for; whether they keep doing their rehabilitation programme at home; and if they decided to get any other treatments themselves after their surgery. We will also interview some of the patients and physiotherapists at the end of the programme, and ask them what they thought of the study, and if there is anything they think could be improved.Summary of Results
Objective: To determine the feasibility of a randomised controlled trial to estimate the effectiveness and cost-effectiveness of a rehabilitation intervention on pain, function and health-related quality of life following neck dissection (ND) after head and neck cancer (HNC).Design: Two-arm, open, pragmatic, parallel, multicentre, randomised controlled feasibility trial.
Setting: UK NHS Hospitals.
Participants: People who had HNC in whom a ND was part of their care. We excluded whose with a life expectancy of six months or less, those with a pre-existing, long-term neurological disease affecting the shoulder and people with cognitive impairment.
Intervention: Usual care was received by all participants during their postoperative inpatient stay, consisting standard NHS care supplemented with a booklet advising on postoperative self-management strategies. The GRRAND intervention programme consisted of usual care plus up to six individual physiotherapy sessions including neck and shoulder range of motion and progressive resistance exercises, advice and education. Between sessions, participants were advised to complete a home exercise programme.
Randomisation: 1:1 randomisation. Allocation was based on minimisation, stratifying by hospital site and spinal accessory nerve sacrifice. There was no blinding.
Main outcome measures: Primary: Participant recruitment, retention rates and fidelity to the study protocol and interventions from study participants and staff across sites at six months post-randomisation (and 12 months for those reaching that time-point). Secondary: clinical measures of pain, function, physical performance, health-related quality of life, health utilisation and adverse events.
Results: 36 participants were recruited and enrolled. The study design reached thresholds for feasibility for five of the six criteria. The study reached ‘green’ thresholds for consent where 70% of eligibility participants consented, intervention fidelity where 78% of participants discharged completed the intervention sessions, contamination there no participants in the control group received the GRRAND-F intervention and retention where only 8% of participants were lost to follow-up. One criterion was categorised as ‘amber’ where 28% of participants demonstrated missing data in the questionnaire. Recruitment was the single criteria which was not met, with a ‘red’ outcome where 36 from the planned 50 participants were recruited within 18 months. Site activity was interrupted due to the COVID-19 pandemic which accounted for this outcome.
Conclusions: Based on the findings from this feasibility study, a full trial can now be designed to better understand whether this proposed rehabilitation interventions is effective for this population.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0457
Date of REC Opinion
12 Sep 2019
REC opinion
Favourable Opinion