Screening for chemotherapy induced peripheral neuropathy: determining the effectiveness of an early identification screening programme
Chemotherapy induced peripheral neuropathy
Randomisation; Following informed consent and after assessment 1, children will be randomised into two groups: usual care versus screening programme (using sealedenvelope.com ensuring allocation concealment). 1. Intervention Group (Screening plus usual care) • Children allocated to the screening group will be screened using the Ped-m TNS (a validated CIPN assessment for children with ALL/non-CNS solid tumours) as follows: S1 at diagnosis, S2 4 weeks, S3 8 weeks, S4 12 weeks, S5 16 weeks and S6 at 24 weeks post diagnosis (screening time points informed by vincristine schedule). • The Edinburgh Visual Gait Score will be undertaken at S1 and S4. • The Oxford foot and ankle questionnaire will be undertaken at S2, 3, 5 and S6. • If a child is identified with CIPN (Ped-m TNS >4), they will access routinely available input, which may include dose modification, referral to therapies and analgesia. Any intervention will be documented. • Physiotherapy approach will be standardised using the Stoplight Programme, to ensure the same criteria/intensity of intervention between the two groups. 2. Usual Care • Usual care group children will continue with their oncology treatment as per routine treatment. If any concerns are raised regarding CIPN by the child/parents/clinicians during routine hospital visits, they will access routinely available input (same as detailed for the screening group). This will be recorded. • If the child is referred to physiotherapy, the initial assessment will include the Ped-m TNS documenting the severity of CIPN on referral to physiotherapy. • If a child is identified with CIPN (Ped-m TNS >4), they will access routinely available input, which may include dose modification, referral to therapies and analgesia. Any intervention will be documented. • Physiotherapy approach will be standardised using the Stoplight Programme, to ensure the same criteria/intensity of intervention between the two groups. 3. Study assessments Both groups of children will be
Newly diagnosed children, 4-<18 years at high risk of CIPN (this will encompass the following diagnoses: children with Acute Lymphoblastic Leukaemia (ALL), Wilms Tumour, Rhabdomyosarcoma, Low grade brain tumour on LGG 2 Protocol). These children are classed as high risk of CIPN as their treatment protocol includes weekly vincristine during their treatment schedule. High incidence of CIPN in these patient groups has been reported in the literature.
1. Medically unstable or presence of co-morbidities affecting safety of screening/outcome measure assessments, or those with relapsed disease. 2. Under the age of 4 years due to inability to complete the chosen outcome measures