ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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]

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

Self-reported cognitive deficit post-chemotherapy

Condition category

Condition code

Cancer

Any cancer

Mental Health

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]

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]

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]

Baseline, and within 4 weeks, 6 months and 12 months post intervention.

Secondary outcome [1]

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]

Baseline, and within 4 weeks, 6 months and 12 months post intervention.

Secondary outcome [2]

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]

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?

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

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2050

Recruitment postcode(s) [2]

2137

Recruitment postcode(s) [3]

2135

Recruitment postcode(s) [4]

2170

Recruitment postcode(s) [5]

2560

Recruitment postcode(s) [6]

2200

Recruitment postcode(s) [7]

2576

Recruitment postcode(s) [8]

2060

Recruitment postcode(s) [9]

2010

Recruitment postcode(s) [10]

2031

Recruitment postcode(s) [11]

2065

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Conquer Cancer Foundation of ASCO

Address [1]

2318 Mills Rd
Suite 800
Alexandria VA22314

Country [1]

United States of America

Funding source category [2]

Charities/Societies/Foundations

Name [2]

National Breast Cancer Foundation

Address [2]

National Breast Cancer Foundation
GPO Box 4126
Sydney
NSW 2001

Country [2]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney
NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Area Health District - Concord Hospital Zone

Ethics committee address [1]

Health Research Ethics Committee
Building 76
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2137

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/07/2012

Approval date [1]

25/07/2013

Ethics approval number [1]

13/CRGH/103

Summary

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

Contacts

Principal investigator

Name

Prof Janette Vardy

Address

Concord Cancer Centre
Concord Repatriation General Hospital
Hospital Rd
Concord NSW 2139

Country

Australia

Phone

61297675000

Fax

janette.vardy@sydney.edu.au

Contact person for public queries

Name

Haryana Dhillon

Address

Centre for Medical Psychology & Evidence-based Decision-making
Central Clinical School, Sydney Medical School
University of Sydney NSW 2006

Country

Australia

Phone

+61 2 9036 5392

Fax

+61 2 9036 5420

Haryana.dhillon@sydney.edu.au

Contact person for scientific queries

Name

Haryana Dhillon

Address

Centre for Medical Psychology & Evidence-based Decision-making
Central Clinical School, Sydney Medical School
University of Sydney NSW 2006

Country

Australia

Phone

+61 2 9036 5392

Fax

+61 2 9036 5420

Haryana.dhillon@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

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
meta-analyses

How or where can data be obtained?

Contacting the Chief investigators via email.
Prof Janette Vardy jvardy@sydney.edu.au
A/Prof Haryana Dhillon haryana.dhillon@sydney.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
15695	Study protocol	haryana.dhillon@sydney.edu.au
15696	Informed consent form	haryana.dhillon@sydney.edu.au
15697	Ethical approval	haryana.dhillon@sydney.edu.au
15698	Other	haryana.dhillon@sydney.edu.au	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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically