Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000750280
Ethics application status
Approved
Date submitted
6/04/2018
Date registered
4/05/2018
Date last updated
31/08/2023
Date data sharing statement initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Telehealth-Delivered Cognitive and Exercise Training on Cognition in Breast Cancer Patients Following Chemotherapy
Scientific title
The Feasibility and Therapeutic Effects of Telehealth-Delivered Cognitive and Exercise Training on Cognition in Breast Cancer Patients Treated with Adjuvant Chemotherapy Agents
Secondary ID [1] 294234 0
None
Universal Trial Number (UTN)
U1111-1210-3035
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 306905 0
Condition category
Condition code
Cancer 305997 305997 0 0
Breast
Physical Medicine / Rehabilitation 306044 306044 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 (cognitive and exercise training versus lifestyle guidance), randomized controlled phase 1 trial. This trial will examine the feasibility, safety and therapeutic benefits of cognitive and exercise training, compared to lifestyle guidance, in stage I-III breast cancer patients treated with chemotherapy agents.

Participants will be randomly assigned (by chance) to receive telehealth-delivered cognitive and exercise training or lifestyle guidance after undertaking their third assessment (after adjuvant chemotherapy).

The CET intervention has been designed by an experienced team of exercise physiologists and cognitive training specialists. It comprises twelve weeks of four times weekly computerised cognitive training and aerobic exercise training (30 minutes each for cognitive and aerobic exercise training). Cognitive and exercise training components of the intervention will be counterbalanced to ensure that both therapeutic modalities are delivered equally (30 minutes of computerised cognitive training vs exercise training). Both components of the intervention will be delivered via telehealth platforms and using the Microsoft Teams application.

The cognitive component of the intervention comprises computerised cognitive training exercises targeting working memory, complex attention, problem solving, planning, and cognitive flexibility and processing speed domains. Computerised cognitive training will be delivered via telehealth application and through the NeuroNation training platform. Customised algorithms developed by our group will be utilised to deliver the aforementioned cognitive training exercises.

The exercise training component of the intervention comprises periodised aerobic exercise. Aerobic exercise will include walking, running, cycling and swimming activities and will be monitored using polar H10 heart rate monitors. Aerobic training sessions will be administered fortnightly by highly experienced exercise physiologists via telehealth (Microsoft Teams). Training adherence will be monitored by exercise physiologists using exercise diaries and heart rate monitors.
Intervention code [1] 300528 0
Rehabilitation
Intervention code [2] 300902 0
Treatment: Other
Comparator / control treatment
Lifestyle guidance will consist evidence-based recommendations regarding cognitive and exercise training. Exercise guidance will follow recommendations by Hayes et al and involve discussing the benefits of exercise and appropriate exercises for people living with cancer. Cognitive recommendations will include learning a new language and undertaking memory, attention and problem-solving exercises. Exercise and cognitive training recommendations will be delivered using Microsoft Teams on a fortnightly basis for up to one hour by an experienced staff member. Following the completion of the study, participants in the lifestyle guidance group will be provided with all training materials related to the cognitive and exercise training intervention.
Control group
Active

Outcomes
Primary outcome [1] 305033 0
The primary outcome for study is feasibility of telehealth-delivered cognitive and exercise training for breast cancer patients receiving adjuvant chemotherapy agents. Feasibility will be assessed using the following indicators in line with previous work (Learmonth et al 2017). Process: participant recruitment and completion (number referred, number eligible, number enrolled, number of withdrawals, trial recruitment rate, trial completion rate). Resources: participant adherence, retention, and attrition rates, as well as communication with participants, the communication needs of participants and staff and the monetary costs of the trial. Management: a realist approach to trial delivery will be applied and assessed via examination of staff time required for recruitment and interaction with participants (enabling economic analysis). Scientific: adverse events (e.g., muscle strain), serious adverse events (e.g., fall resulting in musculoskeletal injury) and clinical emergencies (e.g., cardiovascular events) will be recorded (via participant diary and a semi-structured interview), as will participant experience (via a trial satisfaction survey), burden and compliance to the trial.
In addition to the aforementioned indicators, we will also evaluate feasibility via investigation of perceived barriers, motivators, benefits and negatives to engagement in the telehealth-delivered cognitive and exercise training using a semi-structured interview.
Timepoint [1] 305033 0
The feasibility of cognitive and exercise training and usual care will be measured throughout the entirety of the trial.
Secondary outcome [1] 343952 0
Verbal learning and memory

Verbal learning and memory will be evaluated using the Hopkins Verbal Learning Test-Revised. This is a composite outcome.
Timepoint [1] 343952 0
Verbal learning and memory will be examined with the Hopkins Verbal Learning Test-Revised after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [2] 343967 0
Aerobic fitness will be examined using a 400 m walk test.
Timepoint [2] 343967 0
Cardiopulmonary fitness will be examined before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and upon completion of cognitive and exercise training.
Secondary outcome [3] 344056 0
Fatigue

Fatigue will be examined using the Brief Fatigue Inventory.
Timepoint [3] 344056 0
Fatigue will be examined after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [4] 344057 0
Physical activity will now be evaluated using the International Physical Activity Questionnaire short form.
Timepoint [4] 344057 0
Physical activity will be examined after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [5] 344060 0
Premorbid Intelligence

The National Adult Reading Test will be used to examine premorbid intelligence.
Timepoint [5] 344060 0
Premorbid Intelligence will be evaluated before chemotherapy.
Secondary outcome [6] 344064 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 [6] 344064 0
Education and occupation history/complexity will be evaluated before chemotherapy.
Secondary outcome [7] 344186 0
Blood sampling

30mL of blood will be drawn from study participants for the exploratory analysis of biological markers associated with cancer related cognitive impairments. This is an exploratory outcome.
Timepoint [7] 344186 0
Blood will be sampled after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [8] 345576 0
Sleep quality will be evaluated with the Pittsburgh Sleep Quality Index.
Timepoint [8] 345576 0
Sleep quality will be examined with the Pittsburgh Sleep Quality Index after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [9] 345578 0
Daytime sleepiness will be evaluated using the Epworth Sleepiness Scale.
Timepoint [9] 345578 0
Daytime sleepiness will be examined with the the Epworth Sleepiness Scale after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [10] 346255 0
Health related quality of life


The EORTC-QLQ-30 will also be used to measure specific indices of quality of life. The EORTC-QLQ-30 was specifically designed to examine health-related quality of life in cancer patients.
Timepoint [10] 346255 0
Health related quality of life will be examined with the EORTC-QLQ-30 after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [11] 346257 0
Attention, visual scanning and cognitive flexibility

Attention, visual scanning and cognitive flexibility will be examined with the Trail Making Test. This is a composite outcome.
Timepoint [11] 346257 0
Attention, visual scanning and cognitive flexibility will be examined with the Trial Making Test after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [12] 346258 0
Processing speed


Processing speed will be examined using the Symbol Digit Modalities Test
Timepoint [12] 346258 0
Processing speed will be examined with the Symbol Digit Modalities Test after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [13] 346260 0
Cognitive dual tasking


Cognitive dual tasking will be evaluated using a progressive subtraction test.
Timepoint [13] 346260 0
Cognitive dual tasking will be examined with progressive subtraction tests after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [14] 346262 0
Social Cognition


Social cognition will be evaluated using the Mini-SEA.
Timepoint [14] 346262 0
Social cognition will be examined with the Mini-SEA before surgery, after surgery/before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and after the completion of cognitive and exercise training.
Secondary outcome [15] 377881 0
Insomnia

Insomnia will be evaluated using the Insomnia Severity Index.
Timepoint [15] 377881 0
Insomnia will be evaluated using the Insomnia Severity Index before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and upon completion of the cognitive and exercise training.
Secondary outcome [16] 406427 0
Emotional Experience

Emotional experience will be evaluated using the Brief Emotional Experience Scale
Timepoint [16] 406427 0
Emotional experience will be evaluated using the Brief Emotional Experience Scale on a weekly basis throughout the course of the study.
Secondary outcome [17] 406428 0
Physical emotional experience

Physical emotional experience will be evaluated using the Brief Emotional Experience Scale-Physical
Timepoint [17] 406428 0
Physical emotional experience will be evaluated using the Brief Emotional Experience Scale-Physical (BEEPS). Physical emotional experience will be evaluated on a weekly basis throughout the entirety of the study.
Secondary outcome [18] 406429 0
Changes in mood outcomes will be evaluated using the depression, anxiety, stress scale (DASS-21).
Timepoint [18] 406429 0
Mood will be evaluated using the DASS-21 before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and upon completion of the cognitive and exercise training.
Secondary outcome [19] 406430 0
Cognitive reserve will be evaluated using the Cognitive Reserve Index. This short questionnaire is regularly used to explore cognitive reserve, which is essential to measure when examining cognitive function.
Timepoint [19] 406430 0
Cognitive reserve will be evaluated using the Cognitive Reserve Index before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and upon completion of the cognitive and exercise training.
Secondary outcome [20] 406431 0
Physical activity levels will be evaluated using the IPAQ-Short. This short questionnaire is commonly used to evaluate physical activity.
Timepoint [20] 406431 0
Physical activity levels will be evaluated using the IPAQ-Short before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and upon completion of the cognitive and exercise training.
Secondary outcome [21] 414834 0
Self-reported cognitive impairments will be evaluated using the Functional Assessment of Cancer Therapy Cognitive Function.
Timepoint [21] 414834 0
Self-reported cognitive impairment will be evaluated using the Functional Assessment of Cancer Therapy Cognitive Function before the commencement of chemotherapy, after chemotherapy/before the commencement of the cognitive and exercise training and upon completion of the cognitive and exercise 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 anthracycline, alkylating, antimetabolite and taxane chemotherapy agents, and 3) patients capable of providing written and informed consent.
Minimum age
21 Years
Maximum age
80 Years
Sex
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 cognitive and exercise 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 cognitive and exercise training or lifestyle guidance 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. The exercise physiologist administering the cognitive and exercise training will not be blinded.
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 (cognitive and exercise 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
28/11/2022
Actual
24/11/2022
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
29/08/2025
Actual
Sample size
Target
40
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10262 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 21928 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 298873 0
Charities/Societies/Foundations
Name [1] 298873 0
Cancer Council WA
Country [1] 298873 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Centre for Precision Health
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 298084 0
None
Name [1] 298084 0
Address [1] 298084 0
Country [1] 298084 0
Other collaborator category [1] 279989 0
Hospital
Name [1] 279989 0
Fiona Stanley Hospital
Address [1] 279989 0
11 Robin Warren Drive, Murdoch, 6150 Western Australia
Country [1] 279989 0
Australia
Other collaborator category [2] 279990 0
University
Name [2] 279990 0
University of Western Australia
Address [2] 279990 0
35 Stirling Hwy, Crawley, 6009, Western Australia
Country [2] 279990 0
Australia
Other collaborator category [3] 279991 0
University
Name [3] 279991 0
University of Melbourne
Address [3] 279991 0
The University of Melbourne, Victoria, 3010
Country [3] 279991 0
Australia
Other collaborator category [4] 279992 0
University
Name [4] 279992 0
German Sports University
Address [4] 279992 0
Am Sportpark Müngersdorf 6, 50933 Köln, Germany
Country [4] 279992 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299814 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 299814 0
11 Robin Warren Dr, Murdoch WA 6150
Ethics committee country [1] 299814 0
Australia
Date submitted for ethics approval [1] 299814 0
13/06/2018
Approval date [1] 299814 0
09/01/2019
Ethics approval number [1] 299814 0
Ethics committee name [2] 299816 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [2] 299816 0
270 Joondalup Drive, Joondalup, 6027, Western Australia
Ethics committee country [2] 299816 0
Australia
Date submitted for ethics approval [2] 299816 0
31/05/2018
Approval date [2] 299816 0
Ethics approval number [2] 299816 0

Summary
Brief summary
Study Aims
This study aims to assess the impact of a telehealth-delivered cognitive and exercise training (CET) program versus lifestyle guidance 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 cognitive & exercise training (CET) program or lifestyle guidance program. Those in the CET group will be asked to undertake cognitive and exercise training four times per week (4 hours in total). The lifestyle guidance group will be provided with evidence-based recommendations regarding cognitive and exercise training. All participants will undergo a series of diagnostic and clinical tests, including blood tests, fitness and cognitive tests, sleep 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 81650 0
Dr Travis Cruickshank
Address 81650 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 81650 0
Australia
Phone 81650 0
+61 8 6304 3416
Fax 81650 0
Email 81650 0
[email protected]
Contact person for public queries
Name 81651 0
Dr Travis Cruickshank
Address 81651 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 81651 0
Australia
Phone 81651 0
+61 8 6304 3416
Fax 81651 0
Email 81651 0
[email protected]
Contact person for scientific queries
Name 81652 0
Dr Travis Cruickshank
Address 81652 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 81652 0
Australia
Phone 81652 0
+61 8 6304 3416
Fax 81652 0
Email 81652 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
Data for this study will be kept confidential in a re-identifiable format. The identifier code will only be available to study investigators. Group data will only be presented at conferences and in publications


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.