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

Victoria Gallyer; Toby O Smith; Beth Fordham; Susan Dutton; Mae Chester-Jones; Sarah E Lamb; Stuart C Winter; GRRAND-F Trial Collaborators

doi:10.1136/bmjopen-2020-045741

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

BMJ Open. 2021 Jun 21;11(6):e045741. doi: 10.1136/bmjopen-2020-045741.

Authors

Victoria Gallyer¹, Toby O Smith^{1

2}, Beth Fordham¹, Susan Dutton³, Mae Chester-Jones³, Sarah E Lamb^{1

4}, Stuart C Winter⁵; GRRAND-F Trial Collaborators

Affiliations

¹ Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, Oxfordshire, UK.
² School of Health Sciences, University of East Anglia, Norwich, UK.
³ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.
⁴ College of Medicine and Health, University of Exeter, Exeter, Devon, UK.
⁵ Nuffield Department of Surgical Sciences, University of Oxford, Oxford, Oxfordshire, UK stuart.winter@nds.ox.ac.uk.

Abstract

Introduction: We will evaluate 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).

Methods and analysis: This is a pragmatic, multicentred, feasibility study. Participants are randomised to usual care (control) or usual care plus an individualised, rehabilitation programme (Getting Recovery Right After Neck Dissection, GRRAND intervention). Adults aged over 18 with HNC for whom ND is part of their care will be recruited from specialist clinics. Participants are randomised in 1:1 ratio using a web-based service. The target sample size is 60 participants. Usual care will be received by all participants during their postoperative inpatient stay consisting standard National Health Service care supplemented with a booklet advising on postoperative self-management strategies. The GRRAND intervention programme consists of usual care plus up to six individual physiotherapy sessions including neck and shoulder range of motion (ROM) and progressive resistance exercises, advice and education. Between sessions participants will be advised to complete a home exercise programme. The primary outcome is to determine recruitment and retention rates from study participants across sites. Outcomes will be measured at 6 and 12 months. Participants and physiotherapists will be invited to an optional qualitative interview at the completion of their involvement in the study. The target qualitative sample size is 15 participants and 12 physiotherapists. Interviews aim to further investigate the feasibility and acceptability of the intervention and to determine wider experiences of the study design and intervention from patient and physiotherapist perspectives.

Ethics and dissemination: Ethical approval was given on 29 October 2019 (National Research Ethics Committee Number: 19/SC/0457). Results will be reported at conferences and in peer-reviewed publications.

Trial registration number: ISRCTN11979997.

Status: Trial recruitment is ongoing and is expected to be completed by 30 August 2021.

Keywords: head & neck surgery; head & neck tumours; rehabilitation medicine.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Cost-Benefit Analysis
Exercise Therapy
Feasibility Studies
Humans
Neck Dissection
Quality of Life*
Randomized Controlled Trials as Topic
State Medicine*

Associated data

ISRCTN/ISRCTN11979997