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Trial registered on ANZCTR


Registration number
ACTRN12618000820202
Ethics application status
Approved
Date submitted
17/04/2018
Date registered
14/05/2018
Date last updated
11/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of computerised cognitive training on cognitive impairments in breast cancer patients receiving adjuvant chemotherapy.
Scientific title
The effect of computerised cognitive training on cognitive impairments in breast cancer patients receiving adjuvant chemotherapy
Secondary ID [1] 294599 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 307423 0
Condition category
Condition code
Cancer 306513 306513 0 0
Breast
Physical Medicine / Rehabilitation 306514 306514 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-blind (assessor blind to group allocation), two-arm (computerized cognitive training versus usual care), randomized controlled phase 1 trial. This trial will examine the feasibility, safety and therapeutic benefits of computerized cognitive training, compared to usual care, in stage I-III breast cancer patients undertaking chemotherapy (minimum of 18 weeks).

Participants will be randomly assigned to computerized cognitive training and usual care groups by an independent biostatistician. Participants will receive computerised cognitive training or usual care for the duration of chemotherapy treatment. Computerised cognitive training will be delivered from commencement through to the completion of chemotherapy (minimum of 18 weeks).

The training program comprises three times weekly computerized cognitive training for 45 minutes. All training sessions will be conducted in the patients home.

The computerised cognitive training program is informed by our previous work in patients with Huntington's disease. This fully-personalised program uses a series of algorithms to adapt training difficulty and content to individual cognitive profiles. Thirty-five exercises covering subdomains of memory, planning, processing speed, inhibition and attention impairments, which are compromised in breast cancer patients, will be delivered by NeuroNation software (Berlin). Adherence to the program will be monitored through the NeuroNation software and via a participant training diary. The program will be run via a secure research server in Perth. Training data will be recorded by the research server and used to analyze the association between cognitive training engagement and clinical response across individuals.

Intervention code [1] 300903 0
Rehabilitation
Intervention code [2] 300904 0
Treatment: Other
Comparator / control treatment
The prospective trial includes a usual care control group. Patients allocated to this group will be asked to maintain their current activities of daily living. Following the trial, the control group will be provided with the computerized cognitive training program.
Control group
Active

Outcomes
Primary outcome [1] 305521 0
Feasibility of computerized cognitive training and usual care for breast cancer patients undertaking chemotherapy (4-6 months).

Feasibility will be measured by evaluating the recruitment and retention of breast cancer patients during the trial, as well as the adherence of breast cancer patients to computerized cognitive training and usual care. The recruitment (number of patients recruited) and retention (number of patient dropouts) of breast cancer patients during the trial will be recorded by the chief principle investigator. Adherence to computerized cognitive training and usual care throughout the trial will be evaluated using training activity logs recorded automatically by NeuroNation software and by participants using training diaries.
Timepoint [1] 305521 0
The feasibility of computerized cognitive training and usual care will be measured throughout the entirety of the trial.
Secondary outcome [1] 345579 0
Verbal learning and memory

Verbal learning and memory will be evaluated using the Hopkins Verbal Learning Test-Revised.
Timepoint [1] 345579 0
Verbal learning and memory will be examined with the Hopkins Verbal Learning Test-Revised before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerized cognitive training and after the completion of computerized cognitive training.
Secondary outcome [2] 345580 0
Habitual Sleep

Habitual sleep will be evaluated using the consensus sleep diary.
Timepoint [2] 345580 0
Habitual sleep will be examined using the consensus sleep diary before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerized cognitive training and after the completion of computerized cognitive training.
Secondary outcome [3] 345581 0
Habitual Sleep/Circadian Rhythm

7 Day Wrist-Worn Actigraphy.
Timepoint [3] 345581 0
Habitual sleep/circadian rhythm will be examined with the 7 day wrist-worn actigraphy before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerized cognitive training and after the completion of computerized cognitive training.
Secondary outcome [4] 345611 0
Sleep Quality

Pittsburgh Sleep Quality Index.
Timepoint [4] 345611 0
Sleep Quality will be examined with the Pittsburgh Sleep Quality Index before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerized cognitive training and after the completion of computerized cognitive training.
Secondary outcome [5] 345612 0
Anxiety and Depression Symptoms

Hospital Anxiety and Depression Scale.
Timepoint [5] 345612 0
Anxiety and depression symptoms will be examined with the Hospital Anxiety and Depression Scale before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerized cognitive training and after the completion of computerized cognitive training.
Secondary outcome [6] 345614 0
Physical Activity

Minnesotata Leisure Time Physical Activity Questionnaire.
Timepoint [6] 345614 0
Physical activity levels will be examined with the Minnesotata Leisure Time Physical Activity Questionnaire before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerized cognitive training and after the completion of computerized cognitive training.
Secondary outcome [7] 345615 0
Psychological Stress

Psychological stress will be evaluated using the Brief Symptom Inventory (BSI-18).
Timepoint [7] 345615 0
Psychological stress will be examined before surgery with the Brief Symptom Inventory (BSI-18) after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [8] 345616 0
Fatigue

Fatigue will be examined using the Brief Fatigue Inventory.
Timepoint [8] 345616 0
Fatigue will be examined before surgery with the Brief Fatigue Inventory after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [9] 345617 0
Social Network Size and Complexity

The Social Network Index (SNI) will be used to examine social network size and complexity.

This is a composite outcome.
Timepoint [9] 345617 0
Social network size and complexity will be examined before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [10] 345618 0
Premorbid Intelligence

The National Adult Reading Test will be used to examine premorbid intelligence.
Timepoint [10] 345618 0
Premorbid Intelligence will be evaluated before surgery.
Secondary outcome [11] 345619 0
Cognitive Leisure

Cognitive Leisure will be examined using the Cognitive Leisure Scale developed by Wilson et al (1999, 2000).
Timepoint [11] 345619 0
Cognitive leisure will be examined before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [12] 345620 0
Education and Occupation History/Complexity

Education and occupational history/complexity will be evaluated using a customized demographic questionnaire.

This is a composite outcome/Questionnaire.
Timepoint [12] 345620 0
Education and occupation history/complexity will be evaluated before surgery.
Secondary outcome [13] 345621 0
Health related quality of life

The EORTC-QLQ-30 will also be used to measure specific indices of health related quality of life quality of life. The EORTC-QLQ-30 was specifically designed to examine health-related quality of life in cancer patients.
Timepoint [13] 345621 0
Health-related quality of life will be examined before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [14] 346267 0
Quality of life

Health-related quality of life outcomes for general health, pain, vitality, social functioning and mental health will be evaluated using the Short Form 36 survey.
Timepoint [14] 346267 0
Health-related quality of life will be examined before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [15] 346268 0
Attention, visual scanning and cognitive flexibility

Attention, visual scanning and cognitive flexibility will be examined with the Trial Making Test.
Timepoint [15] 346268 0
Attention, visual scanning and cognitive flexibility will be examined with the Trail Making Test before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [16] 346269 0
Verbal Fluency

The Controlled Oral Word Association test will be used to evaluate verbal fluency.
Timepoint [16] 346269 0
Verbal fluency will be evaluate with the Controlled Word Association Test before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [17] 346270 0
Processing speed


Processing speed will be evaluated with the Symbol Digit Modalities Test.
Timepoint [17] 346270 0
Processing speed will be evaluated with the Symbol Digit Modalities Test before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [18] 346271 0
Executive function

Executive function will be evaluated with the Rey Complex Figure Test.
Timepoint [18] 346271 0
Executive function will be evaluated with the Rey Complex Figure Test before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [19] 346272 0
Social Cognition

Social cognition will be evaluated with the Reading The Mind In The Eyes Test.
Timepoint [19] 346272 0
Social cognition will be evaluated with the Reading The Mind In The Eyes Test before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [20] 346273 0
Emotion Recognition


Emotion recognition will be evaluated with the Cambridge Faces Test.
Timepoint [20] 346273 0
Emotion recognition will be evaluated with the Cambridge Faces Test before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [21] 346274 0
Social cognition


Social cognition will be evaluate with the mini-Social and Cognition and Emotional Assessment.
Timepoint [21] 346274 0
Social cognition will be evaluated with the mini-Social and Cognition and Emotional Assessment before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [22] 346275 0
Cognitive dual tasking


Cognitive dual tasking will be evaluated with the progressive subtraction test.
Timepoint [22] 346275 0
Cognitive dual tasking will be evaluated with the progressive subtraction test before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.
Secondary outcome [23] 346276 0
Self-reported cognitive complaints

Self-reported cognitive complaints will be evaluated with the Functional Assessment of Cancer Therapy Cognitive Function.
Timepoint [23] 346276 0
Self-reported cognitive complaints will be evaluated with the Functional Assessment of Cancer Therapy Cognitive Function before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the computerised cognitive training and after the completion of computerised cognitive training.

Eligibility
Key inclusion criteria
Inclusion criteria include: 1) patients with stage I-III breast cancer prior to first line treatment, 2) patients that will receive adjuvant chemotherapy agents, and 3) patients capable of providing written and informed consent.
Minimum age
21 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: 1) patients with brain metastases, and 2) patients with concomitant neurological, cardiovascular, and psychological conditions, and 3) patients unable to engage in computerised cognitive training,

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)
Participants will be randomly allocated to computerised cognitive training or usual care treatment groups by an independent biostatistician. All assessors will be blinded to group allocation. The biostatistician responsible for analysing the data will also be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization stratified by age and medical treatment. Randomization ratio of 1:1 (computerised cognitive training to usual care)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Data will be assessed using SPSS (IBM Corporation, Chicago, IL, USA) and R statistical software. Linear mixed modeling will be used to examine changes in primary and secondary outcomes over time. All analyses will be conducted in an intention-to-treat manner.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10686 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 10687 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [3] 10688 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 22407 0
6150 - Murdoch
Recruitment postcode(s) [2] 22408 0
6008 - Subiaco
Recruitment postcode(s) [3] 22409 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 299220 0
University
Name [1] 299220 0
Edith Cowan University
Address [1] 299220 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country [1] 299220 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 298484 0
None
Name [1] 298484 0
Address [1] 298484 0
Country [1] 298484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300141 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 300141 0
11 Robin Warren Dr, Murdoch WA 6150
Ethics committee country [1] 300141 0
Australia
Date submitted for ethics approval [1] 300141 0
31/05/2018
Approval date [1] 300141 0
Ethics approval number [1] 300141 0
Ethics committee name [2] 300148 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [2] 300148 0
270 Joondalup Drive, Joondalup, 6027, Western Australia
Ethics committee country [2] 300148 0
Australia
Date submitted for ethics approval [2] 300148 0
31/08/2018
Approval date [2] 300148 0
18/09/2018
Ethics approval number [2] 300148 0
RGS0000001127

Summary
Brief summary
Study Aims
This study aims to assess the impact of a computerised cognitive training program on the neurotoxic effects of chemotherapy on cognition in breast cancer patients.

Who is it for?
You may be eligible to participate in this study if you are aged 21 years or older, have been diagnosed with Stage I-III breast cancer and are scheduled to receive chemotherapy treatment.

Study details
Participants will be randomly assigned (by chance) to receive either the computerised cognitive training program, or continue with standard care. Those in the computerised cognitive training group will undergo 3 x 45 minute sessions for the duration of their chemotherapy (minimum of 18 weeks) The standard care group will be provided with details of the computerised cognitive training program. All participants will undertake a series of clinical assessments, including cognitive, mood, sleep, physical activity, quality of life tests and questionnaires.

Potential study outcomes
It is hoped this research will inform the treatment of breast cancer patients presenting with detrimental cognitive changes as a result of chemotherapy, and this research may lead to better quality of life for patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82686 0
Dr Travis Cruickshank
Address 82686 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 82686 0
Australia
Phone 82686 0
+61 8 6304 3416
Fax 82686 0
Email 82686 0
t.cruickshank@ecu.edu.au
Contact person for public queries
Name 82687 0
Dr Travis Cruickshank
Address 82687 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 82687 0
Australia
Phone 82687 0
+61 8 6304 3416
Fax 82687 0
Email 82687 0
t.cruickshank@ecu.edu.au
Contact person for scientific queries
Name 82688 0
Dr Travis Cruickshank
Address 82688 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 82688 0
Australia
Phone 82688 0
+61 8 6304 3416
Fax 82688 0
Email 82688 0
t.cruickshank@ecu.edu.au

No data has been provided for results reporting
Summary results
Not applicable