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Trial registered on ANZCTR


Registration number
ACTRN12609000683235
Ethics application status
Approved
Date submitted
13/07/2009
Date registered
11/08/2009
Date last updated
23/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a brain training programme in cancer survivors self reporting cognitive changes
Scientific title
Evaluation of a Web-Based Cognitive Rehabilitation Programme in Cancer Survivors with Self Reported Cognitive Impairment
Secondary ID [1] 252941 0
Nil
Universal Trial Number (UTN)
Trial acronym
Brain train
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment in cancer survivors 237236 0
Condition category
Condition code
Cancer 237459 237459 0 0
Breast
Cancer 239555 239555 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 239556 239556 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A home based, computerised cognitive rehabilitation programme to be used for 4x forty-minute sessions per week for a total of 15 weeks (i.e. 40 hours).
There are five training exercises that form the core of the program, each targeting a different area of brain functioning. These cognitive targets include visual precision, divided attention, working memory, useful field of view and visual processing speed. Each exercise has an accompanying assessment that sets an improvement goal and measures progress against that goal. The exercises adapt to an individual’s performance and all patients will complete a recommended schedule of training as per the programme design.
Intervention code [1] 236927 0
Treatment: Devices
Intervention code [2] 236929 0
Rehabilitation
Comparator / control treatment
The control group will receive standard medical care, which for most is routine review with their oncologist.

Both groups will in addition receive a single 30 minute telephone consultation teaching strategies to manage cognitive impairment. The consultation will occur following randomisation, but prior to commencement of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 238353 0
The primary endpoint is self reported cognitive function as assessed by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG).
The primary outcome will be the difference between the intervention group and the control group in the change in FACT-COG score on completion of the cognitive rehabilitation program compared to the baseline score.
Timepoint [1] 238353 0
Self reported cognitive function as measured by FACT-COG will be evaluated at 3 time points. These assessments will be at baseline, on completion of the 15 week intervention and 6 months following completion of the intervention.
Secondary outcome [1] 244784 0
The major secondary outcome is objective neuropsychological testing as assessed by the CogState battery of tests. The CogState tool is a computerised battery of tests evaluating memory, attention and decision making.
Timepoint [1] 244784 0
Neuropsychological testing as assessed by the CogState battery will be performed at 3 time points including baseline, on completion of the 15 week intervention and 6 months following completion of the intervention.
Secondary outcome [2] 244785 0
Quality of life as assessed by the Functional Assessment of Cancer Therapy - General questionnaire (FACT-G)
Timepoint [2] 244785 0
The quality of life questionnaire (FACT-G) will be administered at 3 time points including baseline, on completion of the 15 week intervention and 6 months following completion of the intervention.
Secondary outcome [3] 244786 0
Depression/Anxiety as assessed by the General Health Questionnaire (GHQ)
Timepoint [3] 244786 0
The depression and anxiety questionnaire (GHQ) will be administered at 3 time points including baseline, on completion of the 15 week intervention and 6 months following completion of the intervention.
Secondary outcome [4] 244787 0
Stress as assessed by the Perceived Stress Scale (PSS)
Timepoint [4] 244787 0
The stress questionnaire (PSS) will be administered at 3 time points including baseline, on completion of the 15 week intervention and 6 months following completion of the intervention.
Secondary outcome [5] 244788 0
Fatigue as assessed by Functional Assessment of Cancer Therapy - Fatigue subscale questionnaire (FACT-F)
Timepoint [5] 244788 0
The fatigue questionnaire (FACT-F) will be administered at 3 time points including baseline, on completion of the 15 week intervention and 6 months following completion of the intervention.

Eligibility
Key inclusion criteria
1. Diagnosis of a primary malignancy for which definitive treatment was performed.
2. Completed a minimum of 3 cycles of potentially curative chemotherapy within the last 6-60 months.
3. Aged 18 years and above.
4. Self reported changes in memory and concentration as per the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire –C30 Cognitive Functioning scale (EORTC-CF)
5. Speak fluent English and read to a year 8 standard.
6. Give written informed consent.
7. Radiotherapy and/or immunotherapy (e.g. trastuzumab, lapatinib, bevacizumab or cetuximab) (if received) must have been completed at least 12 weeks prior to randomisation.
8. Hormonal treatment (including tamoxifen or an aromatase inhibitor) is permitted providing treatment has been commenced at least 4 weeks prior to randomisation. Change of hormonal therapy should not be anticipated within the next 6 months, nor should it be likely to be ceased within 6 months.
9. Easy access to computer and internet facilities.
10. Participants are expected to be able to complete the study and be available for follow up.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) Performance Status of > 2.
2. Any evidence of locally recurrent or metastatic disease.
3. Any active psychiatric diagnosis or history of a cognitive disorder. Psychotropic medications are permitted if the patient is established on a stable regime and dosing schedule.
4. Pre-existing neurological condition or any other co-morbidity, which would interfere with their ability to perform cognitive testing.
5. Prior malignancy within the last 5 years (other than non-melanomatous skin cancer, cervical cancer in-situ and the cancer of interest for which they received their chemotherapy).
6. Any previous chemotherapy other than that given for the cancer of interest.

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)
Allocation will be a central randomisation by telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation for primary tumour type and use of hormone treatments for breast cancer patients
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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)
NSW,VIC,ACT,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 237321 0
Self funded/Unfunded
Name [1] 237321 0
Address [1] 237321 0
Country [1] 237321 0
Australia
Primary sponsor type
Individual
Name
Dr Janette Vardy
Address
Sydney Cancer Centre,
Concord Repatriation General Hospital
Hospital Road,
Concord
NSW 2139
Country
Australia
Secondary sponsor category [1] 236804 0
Individual
Name [1] 236804 0
Ms Haryana Dhillon
Address [1] 236804 0
Medical Psychology Research Unit,
Cancer Medicine,
Faculty of Medicine,
Blackburn Building,
University of Sydney.
NSW 2006
Country [1] 236804 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239420 0
Sydney South West Area Health Service - Concord Repatriation General Hospital
Ethics committee address [1] 239420 0
Concord Repatriation General Hospital,
Hospital Road,
Concord.
NSW 2139
Ethics committee country [1] 239420 0
Australia
Date submitted for ethics approval [1] 239420 0
Approval date [1] 239420 0
02/03/2009
Ethics approval number [1] 239420 0
08/CRGH/241

Summary
Brief summary
This study is evaluating a home and internet based “brain training programme” (cognitive rehabilitation programme) in cancer survivors who have noticed changes in their memory, concentration and thinking (cognition) following chemotherapy.

This trial will recruit cancer survivors aged 18 and above who have completed a minimum of 3 cycles of chemotherapy in the last 6 – 60 months for an early cancer. There should be no evidence of cancer recurrence. Potential participants must report changes in their memory and / or concentration.

All study participants will take part in a telephone session where they will be given skills to help manage their cognitive difficulties. In addition, half of the participants will receive the computer programme which is to be used for 4 x forty minute sessions per week for 15 weeks (i.e. 40 hours).

Participants will be asked to complete questionnaires about their memory, mood, energy levels, quality of life and stress. They will also be asked to perform a 20 minute computer cognition exercise. The questionnaires and cognition exercise will take approximately 45 minutes to complete in total and these tests will be completed on 3 occasions during the trial (i.e. at baseline, on completion of the brain training programme and 6 months following completion of the brain training programme).

The computer programme, questionnaires and cognition exercise can all be completed at home and participants will therefore require access to computer and internet facilities.

This study will measure the effectiveness of the computer programme in improving self reported cognitive function and performance, mood, energy, quality of life and stress.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29830 0
Address 29830 0
Country 29830 0
Phone 29830 0
Fax 29830 0
Email 29830 0
Contact person for public queries
Name 13077 0
Dr Victoria Bray
Address 13077 0
Sydney Cancer Centre
Concord Repatriation General Hospital
Hospital Road,
Concord
NSW 2139
Country 13077 0
Australia
Phone 13077 0
+61 2 97675132
Fax 13077 0
+61 2 97675764
Email 13077 0
victoria.bray2@sswhas.nsw.gov.au
Contact person for scientific queries
Name 4005 0
Dr Victoria Bray
Address 4005 0
Sydney Cancer Centre
Concord Repatriation General Hospital
Hospital Road,
Concord
NSW 2139
Country 4005 0
Australia
Phone 4005 0
+61 2 97675132
Fax 4005 0
+61 2 97675764
Email 4005 0
victoria.bray2@sswhas.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results