Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000865516
Ethics application status
Approved
Date submitted
18/06/2024
Date registered
15/07/2024
Date last updated
3/10/2024
Date data sharing statement initially provided
15/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
CanSTEP: Effect of cognitive-motor step exergame training on chemotherapy-induced peripheral neuropathy (CIPN) symptoms in cancer survivors
Scientific title
CanSTEP: Effect of cognitive-motor step exergame training on chemotherapy-induced peripheral neuropathy (CIPN) symptoms in cancer survivors
Secondary ID [1] 311390 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CanSTEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy-induced peripheral neuropathy 332787 0
Condition category
Condition code
Cancer 329507 329507 0 0
Any cancer
Neurological 330706 330706 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327924 0
Rehabilitation
Intervention code [2] 327925 0
Treatment: Devices
Comparator / control treatment
The no-training waitlist control group will receive usual care and encouraged to maintain their usual physical activities. In this study, usual care is defined as care usually received by patients in daily practice. They will be offered the four-month cognitive-motor exergame intervention following study completion at 6 months.
Control group
Active

Outcomes
Primary outcome [1] 337304 0
Self-reported neuropathy symptoms burden - EORTC QLQ CIPN-20
Timepoint [1] 337304 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment (primary endpoint), 6-month post-baseline follow-up
Secondary outcome [1] 431403 0
Self-reported disability -CIPN Rasch-built Overall Disability Scale (CIPN-R-ODS)
Timepoint [1] 431403 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [2] 431404 0
Self-reported quality of life -EORTC Quality of Life Questionnaire-30 item
Timepoint [2] 431404 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [3] 431405 0
Self-reported fatigue - Self-administered Multidimensional Fatigue Inventory (MFI) - 20 item
Timepoint [3] 431405 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [4] 431406 0
Self-reported pain- Numeric Rating Scale (NRS) - 11-point scale
Timepoint [4] 431406 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [5] 435850 0
Self-reported neuropathic pain - Neuropathic Pain Scale
Timepoint [5] 435850 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [6] 435860 0
Physical activity- International Physical Activity Questionnaire Short Form (IPAQ-SF) - 7 item
Timepoint [6] 435860 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [7] 435869 0
Past falls
Timepoint [7] 435869 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [8] 435870 0
Concern about falls - Falls-Efficacy Scale-International (FES-I)
Timepoint [8] 435870 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [9] 435871 0
Self-efficacy -Self-Efficacy for Managing Chronic Disease 6-item Scale
Timepoint [9] 435871 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [10] 435872 0
Health-related Quality of Life -EuroQol group 5-Dimensions (EQ-5D)
Timepoint [10] 435872 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [11] 435877 0
Health Resources Utilisation questionnaire
Timepoint [11] 435877 0
Baseline, 8-week post-baseline assessment, 16-week post-baseline assessment, 6-month post-baseline follow-up
Secondary outcome [12] 435878 0
Balance - postural sway standing on floor with eyes open
Timepoint [12] 435878 0
Baseline, 16-week post-baseline assessment
Secondary outcome [13] 435879 0
Dynamic balance - coordinated stability
Timepoint [13] 435879 0
Baseline, 16-week post-baseline assessment
Secondary outcome [14] 435880 0
Gait speed - 6m walk test
Timepoint [14] 435880 0
Baseline, 16-week post-baseline assessment
Secondary outcome [15] 435881 0
Functional mobility - Timed Up and Go test
Timepoint [15] 435881 0
Baseline, 16-week post-baseline assessment
Secondary outcome [16] 435882 0
Mobility - Five Sit to Stand test
Timepoint [16] 435882 0
Baseline, 16-week post-baseline assessment
Secondary outcome [17] 435883 0
Choice Stepping Reaction Time
Timepoint [17] 435883 0
Baseline, 16-week post-baseline assessment
Secondary outcome [18] 435884 0
Executive function - Trail Making Test part A
Timepoint [18] 435884 0
Baseline, 16-week post-baseline assessment
Secondary outcome [19] 435885 0
Response Inhibition - Victoria Stroop test
Timepoint [19] 435885 0
Baseline, 16-week post-baseline assessment
Secondary outcome [20] 435887 0
Daily physical activity for a week
Timepoint [20] 435887 0
In the 7-day period preceding baseline assessment, in the 7-day period preceding the 16-week post-baseline assessment, in the 7-day period preceding the 6-month post-baseline follow-up
Secondary outcome [21] 436037 0
Stroop stepping test total reaction time
Timepoint [21] 436037 0
Baseline, 16-week post-baseline assessment
Secondary outcome [22] 436928 0
Trail Making Test Part B performance
Timepoint [22] 436928 0
Baseline, 16-week post baseline assessment
Secondary outcome [23] 436929 0
Postural sway standing on floor eyes closed
Timepoint [23] 436929 0
Baseline, 16-week post baseline assessment
Secondary outcome [24] 436930 0
Postural sway standing on foam with eyes open
Timepoint [24] 436930 0
Baseline, 16-week post baseline assessment
Secondary outcome [25] 436931 0
Postural sway standing on foam for 30s with eyes closed
Timepoint [25] 436931 0
Baseline, 16-week post baseline assessment
Secondary outcome [26] 440411 0
Inhibitory stepping test total reaction time
Timepoint [26] 440411 0
Secondary outcome [27] 440412 0
Inhibitory stepping test total reaction time
Timepoint [27] 440412 0
Baseline, 16-week post-baseline assessment

Eligibility
Key inclusion criteria
- aged 18 years and over;
- greater or equal to 6 months and less than 5 years post-completion of neurotoxic chemotherapy treatment for cancer;
- no scheduled further neurotoxic cancer treatment;
- chemotherapy-induced peripheral neuropathy symptoms impacting lower limbs function;
- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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;
- have insufficient language skills to provide informed consent and fully participate in the program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following completion of baseline assessment, participants will be randomised using a web-based randomisation service performed centrally. i.e. a concealed randomisation system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Blocks of 2, 4 and 6 will be applied to form two groups of similar size (1:1 allocation), stratified by study site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
The participants will be randomly allocated to intervention or waitlist control groups immediately following completion of the baseline assessment (same day). For participants assigned to the intervention group, the exergame step mat system will be installed in the intervention participants home on the same day as the baseline assessment and randomisation so that the intervention can commence immediately.
For participants assigned to wait-list control, the exergame step mat system will be installed in the control participants homes following completion of the study, that is following the 6-month post-baseline follow up.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention-to-treat approach will be employed to analyse the effectiveness, cost-utility and cost-effectiveness of the intervention. Generalised linear models will be used to assess the effect of group allocation on the primary outcome measure of symptom burden (EORTC QLQ CIPN-20) as well as on the continuously scored secondary outcome measures (symptom burden, quality of life, balance and mobility, executive function, pain, fatigue, fear of falling) of potential effectiveness at follow-up time points, controlling for baseline performance and study site. The probability threshold will be set at p<0.05.

The outcome of our cost-utility and cost-effectiveness analyses is the incremental cost-utility/effectiveness ratio (ICUR/ICER) using four- and six-months’ time horizons. An ICUR/ICER represents the difference between the mean costs of providing the competing interventions divided by the difference in effectiveness, We will determine the incremental cost of the intervention relative to usual care per QALY (Quality-adjusted Life Years) gained. QALYs will be estimated using UK valuations for health state utility values from the EQ-5D-5L as Australian tariffs are not available. We will use a combination of multiple imputations and bootstrapping to quantify uncertainty due to missing values and the finite study sample size. Bootstrapping will be used to estimate a distribution around costs and health outcomes, and to calculate the confidence intervals around the incremental cost-effectiveness and cost-utility ratios. Cost-effectiveness acceptability curves will be plotted to provide information about the probability that the intervention is cost-effective.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2024
Actual
2/09/2024
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
178
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 26146 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 26148 0
Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [3] 26518 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 26698 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 42006 0
2031 - Randwick
Recruitment postcode(s) [2] 42007 0
2050 - Camperdown
Recruitment postcode(s) [3] 42008 0
4000 - Brisbane City
Recruitment postcode(s) [4] 42009 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 315649 0
Government body
Name [1] 315649 0
NHMRC Clinical Trials and Cohort Studies
Country [1] 315649 0
Australia
Funding source category [2] 316454 0
Charities/Societies/Foundations
Name [2] 316454 0
World Cancer Research Fund
Country [2] 316454 0
United Kingdom
Funding source category [3] 316690 0
Charities/Societies/Foundations
Name [3] 316690 0
Cancer Australia
Country [3] 316690 0
Australia
Funding source category [4] 317555 0
Charities/Societies/Foundations
Name [4] 317555 0
World Cancer Research Fund International
Country [4] 317555 0
United Kingdom
Primary sponsor type
Individual
Name
Dr Jasmine Menant
Address
Country
Australia
Secondary sponsor category [1] 318843 0
Individual
Name [1] 318843 0
Dr Daina Sturnieks
Address [1] 318843 0
Country [1] 318843 0
Australia
Secondary sponsor category [2] 318882 0
Individual
Name [2] 318882 0
Associate Professor Susanna Park
Address [2] 318882 0
Country [2] 318882 0
Australia
Secondary sponsor category [3] 318883 0
Individual
Name [3] 318883 0
Professor David Goldstein
Address [3] 318883 0
Country [3] 318883 0
Australia
Secondary sponsor category [4] 318884 0
Individual
Name [4] 318884 0
Professor Stephen Lord
Address [4] 318884 0
Country [4] 318884 0
Australia
Secondary sponsor category [5] 318885 0
Individual
Name [5] 318885 0
Assistant Professor Jennifer Davis
Address [5] 318885 0
Country [5] 318885 0
Canada
Secondary sponsor category [6] 318886 0
Individual
Name [6] 318886 0
Dr David Mizrahi
Address [6] 318886 0
Country [6] 318886 0
Australia
Secondary sponsor category [7] 318887 0
Individual
Name [7] 318887 0
Professor Bogda Koczwara
Address [7] 318887 0
Country [7] 318887 0
Australia
Secondary sponsor category [8] 318888 0
Individual
Name [8] 318888 0
Associate Professor Peter Grimison
Address [8] 318888 0
Country [8] 318888 0
Australia
Secondary sponsor category [9] 318889 0
Individual
Name [9] 318889 0
Professor Patsy Yates
Address [9] 318889 0
Country [9] 318889 0
Australia
Secondary sponsor category [10] 318890 0
Individual
Name [10] 318890 0
Associate Professor David Wyld
Address [10] 318890 0
Country [10] 318890 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314534 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 314534 0
Ethics committee country [1] 314534 0
Australia
Date submitted for ethics approval [1] 314534 0
07/01/2024
Approval date [1] 314534 0
07/03/2024
Ethics approval number [1] 314534 0
2023/ETH02530

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131922 0
Dr Jasmine Menant
Address 131922 0
NeuRA, 139 Barker St, Randwick NSW 2031
Country 131922 0
Australia
Phone 131922 0
+61 2 9399 1267
Fax 131922 0
Email 131922 0
[email protected]
Contact person for public queries
Name 131923 0
Dr Jasmine Menant
Address 131923 0
NeuRA, 139 Barker St, Randwick NSW 2031
Country 131923 0
Australia
Phone 131923 0
+61 2 9399 1267
Fax 131923 0
Email 131923 0
[email protected]
Contact person for scientific queries
Name 131924 0
Dr Jasmine Menant
Address 131924 0
NeuRA, 139 Barker St, Randwick NSW 2031
Country 131924 0
Australia
Phone 131924 0
+61 2 9399 1267
Fax 131924 0
Email 131924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Approval will be sought from the ethics committee before it can be confirmed that IPD will be available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.