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

Conditions

Head and neck cancer Cancer

Toby O. Smith, Angela Garrett, Tianshu Liu, Alana Morris, Victoria Gallyer et al. (10 authors)

Frontiers in Oncology2023-03-163 citations

10.3389/fonc.2023.1110500

Patient and physiotherapist perceptions of the Getting Recovery Right After Neck Dissection (GRRAND) rehabilitation intervention: a qualitative interview study embedded within a feasibility trial

Beth Fordham, Toby O. Smith, Sarah E Lamb, Alana Morris, Stuart C. Winter

BMJ Open2022-11-016 citations

10.1136/bmjopen-2022-064269

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 et al. (7 authors)

BMJ Open2021-06-012 citations

10.1136/bmjopen-2020-045741

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

England, United Kingdom

Outcome results

None listed