Dataset Information

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

ABSTRACT:

Objective

To determine the feasibility of a randomised controlled trial to estimate the effectiveness and cost-effectiveness of a rehabilitation intervention following neck dissection (ND) after head and neck cancer (HNC).

Design

Two-arm, open, pragmatic, parallel, multicentre, randomised controlled feasibility trial.

Setting

Two UK NHS hospitals.

Participants

People who had HNC in whom a ND was part of their care. We excluded those with a life expectancy of six months or less, pre-existing, long-term neurological disease affecting the shoulder and cognitive impairment.

Intervention

Usual care (standard care supplemented with a booklet on postoperative self-management) was received by all participants. 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, stratified by hospital site and spinal accessory nerve sacrifice. It was not possible to mask treatment received.

Main outcome measures

Primary: Participant recruitment, retention and fidelity to the study protocol and interventions from study participants and staff 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 achieved five of its six feasibility targets. These included consent - 70% of eligible participants were consented; intervention fidelity - 78% participants discharged completed the intervention sessions; contamination - none - no participants in the control arm received the GRRAND-F intervention and retention - 8% of participants were lost to follow-up. The only feasibility target that was not achieved was the recruitment target where only 36 of the planned 60 participants were recruited over 18 months. This was principally due to the COVID-19 pandemic which caused all research activity to be paused or reduced, with a subsequent reduction in.

Conclusions

Based on the findings a full-trial can now be designed to better understand whether this proposed intervention is effective.

Clinical trial registration

https://www.isrctn.com/ISRCTN1197999, identifier ISRCTN11979997.

SUBMITTER: Smith TO

PROVIDER: S-EPMC10061058 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Smith Toby O TO Garrett Angela A Liu Tianshu T Morris Alana A Gallyer Victoria V Fordham Bethany A BA Dutton Susan J SJ Chester-Jones Mae M Lamb Sarah E SE Winter Stuart Charles SC

Frontiers in oncology 20230316

<h4>Objective</h4>To determine the feasibility of a randomised controlled trial to estimate the effectiveness and cost-effectiveness of a rehabilitation intervention following neck dissection (ND) after head and neck cancer (HNC).<h4>Design</h4>Two-arm, open, pragmatic, parallel, multicentre, randomised controlled feasibility trial.<h4>Setting</h4>Two UK NHS hospitals.<h4>Participants</h4>People who had HNC in whom a ND was part of their care. We excluded those with a life expectancy of six mont ...[more]

PMID: 37007098

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Project description:IntroductionWe 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 analysisThis 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 disseminationEthical 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 numberISRCTN11979997.StatusTrial recruitment is ongoing and is expected to be completed by 30 August 2021.

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Project description:IntroductionSurvivors of critical illness and their caregivers are at risk for long-term cognitive, physical and psychiatric impairments known as post-intensive care syndrome (PICS) and PICS-family, respectively. This study will assess the feasibility of a randomised controlled trial (RCT) evaluating an intensive care unit (ICU) follow-up care bundle versus standard-of-care for ICU patients and their caregivers.Methods and analysisThis is a single-centre feasibility study. Survivors of critical illness will be eligible if: age ≥18 years, life expectancy ≥6 months and high risk for PICS. We define high risk as ICU stay ≥4 days or involving 1+ of mechanical ventilation, tracheostomy, delirium or lack of access to a primary care physician (PCP). 20 ICU survivor-primary caregiver dyads will be enrolled (n=10 dyads per group) and randomised 1:1 to the intervention versus control group. The intervention will be: (1) diaries to journal patient experiences, (2) information packages on expectations post-discharge and (3) specialised follow-up care at 1 and 3 months post-discharge. The control group will receive standard of care in the ICU and follow-up with their PCP. The primary outcome is feasibility, defined as: (1) consent rate >80%, (2) enrolment rate of 4 participants/month, (3) follow-up rate>70% and (4) data capture rate >80%. Our secondary objective is to explore the perspectives of survivors of critical illness and their families about the intervention and their participation in the study. Tertiary outcomes will be a battery of cognitive, physical functioning and psychiatric outcomes.ImplicationsSurvivorship from critical illness extends beyond surviving an ICU stay. This project will lay the foundation for performing a large, multicentre pragmatic RCT with survivors of critical illness and their caregivers, paving the way for improved long-term healthcare.Ethics and disseminationThis study has received approval (6039808) from the Queen's University Health Sciences/Affiliated Teaching Hospitals Research Ethics Board. Results will be presented at critical care conferences. A lay summary co-designed with ICU survivor participants will be provided to patients.Trial registration numberNCT06681649.

Project description:IntroductionMillions of patients receive general anaesthesia for surgery annually. Crucial gaps in evidence exist regarding which technique, propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA), yields superior patient experience, safety and outcomes. The aim of this pilot study is to assess the feasibility of conducting a large comparative effectiveness trial assessing patient experiences and outcomes after receiving propofol TIVA or INVA.Methods and analysisThis protocol was cocreated by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 300-patient, two-centre, randomised, feasibility pilot trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to propofol TIVA or INVA, stratified by centre and procedural complexity. The feasibility endpoints include: (1) proportion of patients approached who agree to participate; (2) proportion of patients who receive their assigned randomised treatment; (3) completeness of outcomes data collection and (4) feasibility of data management procedures. Proportions and 95% CIs will be calculated to assess whether prespecified thresholds are met for the feasibility parameters. If the lower bounds of the 95% CI are above the thresholds of 10% for the proportion of patients agreeing to participate among those approached and 80% for compliance with treatment allocation for each randomised treatment group, this will suggest that our planned pragmatic 12 500-patient comparative effectiveness trial can likely be conducted successfully. Other feasibility outcomes and adverse events will be described.Ethics and disseminationThis study is approved by the ethics board at Washington University (IRB# 202205053), serving as the single Institutional Review Board for both participating sites. Recruitment began in September 2022. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.Trial registration numberNCT05346588.

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Dataset Information

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

Objective

Design

Setting

Participants

Intervention

Randomisation

Main outcome measures

Results

Conclusions

Clinical trial registration

Publications

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

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