None listed
Conditions
Brief summary
This study aims to determine the effectiveness and cost-effectiveness of a four-month home-based cognitive-motor step training intervention versus usual care in cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN). Who is it for? You may be eligible for this study if you are aged 18 years or over and have completed greater or equal to 6 months and less than 5 years post-completion of neurotoxic chemotherapy treatment for cancer, with CIPN symptoms impacting lower limbs function. You should also be able to walk 10 metres without the use of a walking aid. Study details Participants will be randomly allocated to either receive the home-based cognitive-motor step exergame training, or usual care with the option to receive the training program following completion of the study period. The exergame training will involve stepping/balance exercises and concurrent cognitive training on a wireless floor step mat, delivered over a few sessions per week with a target range of 80 to 120 minutes total training per week for 16 weeks. Participants will be asked to complete questionnaires about their symptoms' burden, quality of life and health service use, as well as to undertake assessments of balance and cognition at several timepoints throughout this study. Participants' daily physical activity will also be recorded at several time points, using a wrist-worn sensor. It is hoped that findings from this study will help develop management strategies to address the ever-increasing burden of CIPN-related disability in cancer survivors.
Interventions
Four-month cognitive-motor rehabilitation program involving step exergame training delivered through a home-based system (SmartStep). All intervention participants will receive the step exergame system (personal computer, software and instruction / safety booklet) and wireless step mat to interface with their television screen or provided computer monitor. The intervention involves unsupervised cognitive-motor training using the step exergame system. The intervention incorporates both stepping/balance exercises and cognitive training. The exergames require participants to make appropriately timed and accurate steps from both legs on the wireless floor step mat. The program of games is designed to train fast stepping responses in addition to cognitive functions of selective attention, response inhibition, working memory, visuo-spatial processing and task switching, Trained research assistants with experience working with balance-impaired clinical groups and trained in exercise physiology, physiotherapy, nursing, neurosciences or biomedical sciences will set up the equipment in participants' homes during a 60-90min initial home visit. The research assistant will instruct participants on how to safely use the program. Following the initial installation visit, intervention participants will receive a follow-up phone call (or online teleconference) after the first two weeks and again at eight weeks to ensure safe use and progression of training and to discuss any issues relating to system use. Additional phone calls (or home visits) during the intervention will be offered as needed. Emails will also be sent at 4 and 12 weeks to ascertain participant adherence to the program. At all points of contact with the study team, participants will be asked if they faced any difficulties using the program and appropriate measures will be taken to resolve any issues. Participants will be encouraged to undertake three to four 20-30 minute training sessions per week progressing to a target range of 80 to 120 minutes per week. We will initially encourage participants to undertake several short training sessions (e.g. 10 to 15min training sessions) per week to maximise confidence and long-term adherence. We will then progressively increase their training sessions duration (by 10% to 20% at a time, considering both physical function and personal preferences / other commitments). Participants’ intervention usage data (minutes of game play each week) will be collected locally on the personal computer and later transferred onto an online server at Neuroscience Research Australia.
Sponsors
Study design
Eligibility
Inclusion criteria
- aged 18 years and over; - greater or equal to 6 months post-completion of neurotoxic chemotherapy treatment for cancer; - no scheduled further neurotoxic cancer treatment; - chemotherapy-induced peripheral neuropathy symptoms impacting physical function in the lower limbs; - able to walk 10 metres without the use of a walking aid; - willing and able to comply with all study requirements, including treatment, timing and nature of required assessments; - have internet access/Wi-Fi and access to a smart device /computer; - be able to communicate in English, or accompanied by a carer who can.
Exclusion criteria
- history of primary brain tumours; - history of metastases (brain or bone) that could affect balance and mobility; - known history of peripheral neuropathy prior to neurotoxic chemotherapy for cancer; - neurological disorders including stroke, Parkinson’s disease, multiple sclerosis, and dementia; - acute psychiatric condition with psychosis; - severe visual impairment; - medical condition precluding balance and stepping exercise;