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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Rehabilitation for Cancer Survivors with Perceived Cognitive Impairment
Scientific title
Cognitive Rehabilitation for Cancer Survivors with Perceived Cognitive Impairment
Secondary ID [1] 280753 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive solid tumour cancers
286808 0
Self-reported cognitive deficit post-chemotherapy 286843 0
Condition category
Condition code
Cancer 287120 287120 0 0
Any cancer
Mental Health 287169 287169 0 0
Studies of normal psychology, cognitive function and behaviour

Study type
Description of intervention(s) / exposure
There are two active intervention arms and a watchful waiting control arm.

Arm 1, A structured neurocognitive learning programme (Attention Process Training [APT –II], aimed at improving underlying cognitive deficit. This intervention focuses on restoring the specific cognitive function, attention.

Arm 2, A systematic teaching of strategies to compensate for the functional impact of cognitive deficits (Compensatory Strategy Training [CST]).This treatment intervention helps patients adapt to the presence of deficits, rather than trying to treat the underlying deficit.

Both active interventions consists of 2-hour small group sessions per week for 6 weeks, with a trained therapist.
Intervention code [1] 285182 0
Treatment: Other
Comparator / control treatment
Patients in the watchful waiting control arm will be given current standard medical care. Standard medical care for this population is follow-up with their treating doctor as per follow-up and monitoring guidelines.
Control group

Primary outcome [1] 287440 0
The primary outcome will be the difference between experimental groups and the control group in the change in a patient's perceived cognitive impairment from baseline to post intervention as measured by their self-rated score on the Percieved Cognitive Impairment (PCI) subscale of the FACT-COG v3 questionnaire.
Timepoint [1] 287440 0
Baseline, and within 4 weeks, 6 months and 12 months post intervention.
Secondary outcome [1] 298152 0
Cognitive functioning as assessed by performance on a battery of neuropsychological and functional tests:- WRAT 3 Reading tests (10 min); Controlled Oral Word Association (COWAT) (5 mins) Thurstone Word Fluent Test (5 mins) Category animal fluency (2 mins) Trail Makings B (3 mins) Wisconsin Cord sorting (64 32 item) (15-20 mins) Stroop (5 mins) WAIS-III Digit symbol (5 mins) Trail Making Tests A (2 mins) Digit Span (5 mins) Letter Number Sequence (5 mins) Spatial Span (5mins) Hopkins Verbal Learning test-R (10 mins) Brief Visuospatial Memory Test-R (10 mins) Grooved pegboard (5 mins) Functional Impact Assessment (FIA) (90 mins)
Timepoint [1] 298152 0
Baseline, and within 4 weeks, 6 months and 12 months post intervention.
Secondary outcome [2] 298153 0
Self-reported Quality of Life (QOL) as measured by the FACT-General (FACT-G).
Anxiety/depression as measured by the Hospital Anxiety and Depression Scale (HADS).
Fatigue as measured by the FACT-fatigue subscale (FACT-F).
Timepoint [2] 298153 0
Baseline, and within 4 weeks, 6 months and 12 months post intervention.

Key inclusion criteria
1 Diagnosis of invasive solid tumour cancer for which definitive treatment was performed within the last 5 years
2 Completed at least 3 cycles of chemotherapy
3 Aged >17 years
4 A “NO” response recorded for the Single Item Cognitive Impairment Question
5 Speak fluent English and read to a year 8 standard.
6 Give written informed consent.
7 Chemotherapy, radiotherapy, immunotherapy (e.g. trastuzumab and/or lapatinib) received must have been completed at least 6 months prior to randomisation.
8 Hormonal treatment (including tamoxifen or an aromatase inhibitor) is permitted as long as treatment has been commenced at least 4 weeks prior to randomisation and is not likely to be ceased within 6 months of randomisation.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1, ECOG Performance Status of > 2
2, Any evidence of extra-nodal metastatic disease.
3, Any major pre-existing neurological condition, co-morbidity, psychiatric history or substance abuse that could interfere with their ability to perform cognitive testing.
4, Prior malignancy within the last 5 years (other than non-melanomatous skin cancer or cervical cancer in-situ) or previous chemotherapy other than adjuvant or neoadjuvant breast cancer treatment.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be performed centrally using an Interactive Voice Response System (IVRS). Allocation will be concealed from site and central study staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic random allocation methods using minimisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people analysing the results/data
Intervention assignment
Other design features
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
Impact of COVID-19
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5486 0
Recruitment postcode(s) [2] 5487 0
Recruitment postcode(s) [3] 5478 0
Recruitment postcode(s) [4] 5485 0
Recruitment postcode(s) [5] 5488 0
Recruitment postcode(s) [6] 5480 0
Recruitment postcode(s) [7] 5479 0
Recruitment postcode(s) [8] 5481 0
Recruitment postcode(s) [9] 5483 0
Recruitment postcode(s) [10] 5482 0
Recruitment postcode(s) [11] 5484 0

Funding & Sponsors
Funding source category [1] 285577 0
Name [1] 285577 0
Conquer Cancer Foundation of ASCO
Country [1] 285577 0
United States of America
Funding source category [2] 300905 0
Name [2] 300905 0
National Breast Cancer Foundation
Country [2] 300905 0
Primary sponsor type
The University of Sydney
The University of Sydney
NSW 2006
Secondary sponsor category [1] 284407 0
Name [1] 284407 0
Address [1] 284407 0
Country [1] 284407 0

Ethics approval
Ethics application status
Ethics committee name [1] 287587 0
Sydney Local Area Health District - Concord Hospital Zone
Ethics committee address [1] 287587 0
Health Research Ethics Committee
Building 76
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2137
Ethics committee country [1] 287587 0
Date submitted for ethics approval [1] 287587 0
Approval date [1] 287587 0
Ethics approval number [1] 287587 0

Brief summary
This study aims to evaluate two cognitive rehabilitation programs in cancer survivors with perceived cognitive dysfunction after chemotherapy.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have had definitive surgery for invasive early cancer within the last 5 years and were treated with adjuvant chemotherapy. You should have completed at least 3 cycles of chemotherapy and be experiencing cognitive changes.

Trial details
Participants in this trial will be randomly (by chance) allocated to one of three groups. Participants in one group will undergo a structured neurocognitive learning programme (Attention Process Training [APT]) in small groups across 6 weeks for 2 hours per week. Participants in the second group will undergo a systematic teaching of strategies to compensate for the functional impact of cognitive deficit (Compensatory Strategy Training [CST]). Again, this rehabilitation program will be conducted in small 2 hour group sessions over a 6 week period. Participants in the third group will receive standard treatment. Participants will complete questionnaires and cognitive tests at baseline, 4 weeks, 6 months and 12 months post intervention in order to determine the efficacy of the two different cognitive rehabilitation programs.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34378 0
Prof Janette Vardy
Address 34378 0
Concord Cancer Centre
Concord Repatriation General Hospital
Hospital Rd
Concord NSW 2139
Country 34378 0
Phone 34378 0
Fax 34378 0
Email 34378 0
Contact person for public queries
Name 17625 0
Dr Haryana Dhillon
Address 17625 0
Centre for Medical Psychology & Evidence-based Decision-making
Central Clinical School, Sydney Medical School
University of Sydney NSW 2006
Country 17625 0
Phone 17625 0
+61 2 9036 5392
Fax 17625 0
+61 2 9036 5420
Email 17625 0
Contact person for scientific queries
Name 8553 0
Dr Haryana Dhillon
Address 8553 0
Centre for Medical Psychology & Evidence-based Decision-making
Central Clinical School, Sydney Medical School
University of Sydney NSW 2006
Country 8553 0
Phone 8553 0
+61 2 9036 5392
Fax 8553 0
+61 2 9036 5420
Email 8553 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
What data in particular will be shared?
Participant demographic and clinical data, neuropsychological performance data.
When will data be available (start and end dates)?
on completion and publication of the study results
no end date
Available to whom?
Other researchers on request
Available for what types of analyses?
hypothesis-generating analyses
How or where can data be obtained?
Contacting the Chief investigators via email.
Prof Janette Vardy
A/Prof Haryana Dhillon

What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15695Study protocol
15696Informed consent form
15697Ethical approval
15698Other Data dictionary

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.