Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001041842
Ethics application status
Approved
Date submitted
5/07/2012
Date registered
28/09/2012
Date last updated
6/04/2022
Date data sharing statement initially provided
6/04/2022
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
Nil
Universal Trial Number (UTN)
U1111-1132-2274
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
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
Anticipated
8/05/2014
Actual
28/05/2014
Date of last participant enrolment
Anticipated
Actual
5/03/2021
Date of last data collection
Anticipated
11/03/2022
Actual
11/02/2022
Sample size
Target
159
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 5478 0
2050
Recruitment postcode(s) [2] 5479 0
2137
Recruitment postcode(s) [3] 5480 0
2135
Recruitment postcode(s) [4] 5481 0
2170
Recruitment postcode(s) [5] 5482 0
2560
Recruitment postcode(s) [6] 5483 0
2200
Recruitment postcode(s) [7] 5484 0
2576
Recruitment postcode(s) [8] 5485 0
2060
Recruitment postcode(s) [9] 5486 0
2010
Recruitment postcode(s) [10] 5487 0
2031
Recruitment postcode(s) [11] 5488 0
2065

Funding & Sponsors
Funding source category [1] 285577 0
Charities/Societies/Foundations
Name [1] 285577 0
Conquer Cancer Foundation of ASCO
Country [1] 285577 0
United States of America
Funding source category [2] 300905 0
Charities/Societies/Foundations
Name [2] 300905 0
National Breast Cancer Foundation
Country [2] 300905 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 284407 0
None
Name [1] 284407 0
Address [1] 284407 0
Country [1] 284407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287587 0
Sydney Local Area Health District - Concord Hospital Zone
Ethics committee address [1] 287587 0
Ethics committee country [1] 287587 0
Australia
Date submitted for ethics approval [1] 287587 0
15/07/2012
Approval date [1] 287587 0
25/07/2013
Ethics approval number [1] 287587 0
13/CRGH/103

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

Contacts
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
Australia
Phone 34378 0
61297675000
Fax 34378 0
Email 34378 0
[email protected]
Contact person for public queries
Name 17625 0
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
Australia
Phone 17625 0
+61 2 9036 5392
Fax 17625 0
+61 2 9036 5420
Email 17625 0
[email protected]
Contact person for scientific queries
Name 8553 0
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
Australia
Phone 8553 0
+61 2 9036 5392
Fax 8553 0
+61 2 9036 5420
Email 8553 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Other researchers on request

Conditions for requesting access:
• -

What individual participant data might be shared?
• Participant demographic and clinical data, neuropsychological performance data.

What types of analyses could be done with individual participant data?
• hypothesis-generating analyses
meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
on completion and publication of the study results
no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Contacting the Chief investigators via email.
Prof Janette Vardy [email protected]
A/Prof Haryana Dhillon [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15695Study protocol  [email protected]
15696Informed consent form  [email protected]
15697Ethical approval  [email protected]
15698Other  [email protected] 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.