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Trial registered on ANZCTR


Registration number
ACTRN12615000156583
Ethics application status
Approved
Date submitted
6/02/2015
Date registered
18/02/2015
Date last updated
28/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Translating the “ReCog” Cognitive Rehabilitation Intervention for Cancer Survivors to a Clinical Setting
Scientific title
Does the "ReCog" Cognitive Rehabilitation Intervention improve cognitive function for cancer survivors when delivered in a clinical setting?
Secondary ID [1] 286122 0
Nil known
Universal Trial Number (UTN)
U1111-1167-0110
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurocognitive problems 294123 0
Breast cancer 294124 0
Condition category
Condition code
Mental Health 294440 294440 0 0
Other mental health disorders
Cancer 294441 294441 0 0
Breast
Physical Medicine / Rehabilitation 294555 294555 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program to be evaluated is a group education and skills training intervention, called “Responding to Cognitive Concerns” (ReCog), which has previously successfully improved subjective and objective cognitive function in survivors of breast cancer and other types of cancer. The program is based on self -regulatory cognitive rehabilitation and cognitive behavioural principles, and employs manuals for clinicians and participants. The program is run in small groups of approximately 4-9 participants. There will be four sessions run at weekly intervals by an occupational therapist, with assistance from an occupational therapy assistant and occupational therapy student, and each session will last for 2 hours. Patients will be asked to practise the learnt strategies and skills in and between sessions, with the ultimate goal of generalising these strategies to their everyday life. Home tasks are expected to take approximately 15 minutes per day. Adherence to the intervention will be monitored via attendance at sessions and completion of home tasks.
Intervention code [1] 291119 0
Rehabilitation
Comparator / control treatment
The main comparison for this study is pre-treatment performance. Effect sizes for pre-treatment/post-treatment differences (if any) will also be compared to other studies of ReCog that have been conducted in research settings. Historical data for one comparison study were collected at Griffith University, Gold Coast, Australia in 2009-2010 (published as Schuurs, A., & Green, H. J. (2012). A feasibility study of group cognitive rehabilitation for cancer survivors: Enhancing cognitive function and quality of life. Psycho-Oncology. doi 10.1002/pon.3102). Data for a second comparison study were collected at Griffith University, Gold Coast, Australia in 2012-2013 (trial ACTRN12615000009516).
Control group
Historical

Outcomes
Primary outcome [1] 294233 0
Cognitive performance on WebNeuro computerised battery
Timepoint [1] 294233 0
Within 2 weeks after completing treatment
Primary outcome [2] 294234 0
Self-reported cognitive function on FACT-Cog 3
Timepoint [2] 294234 0
Within 2 weeks after completing treatment
Secondary outcome [1] 312854 0
Psychological distress, as measured by Kessler-10
Timepoint [1] 312854 0
Within 2 weeks after completing treatment
Secondary outcome [2] 312855 0
Quality of life, as measured by EORTC-QLQ-C30
Timepoint [2] 312855 0
Within 2 weeks after completing treatment
Secondary outcome [3] 312856 0
Psychological Needs, as measured by the Balanced Measure of Psychological Needs Scale
Timepoint [3] 312856 0
Within 2 weeks after completing treatment
Secondary outcome [4] 312857 0
Participant satisfaction, as measured by self-report Participant Satisfaction Scale
Timepoint [4] 312857 0
Within 2 weeks after completing treatment

Eligibility
Key inclusion criteria
Participants will meet the following inclusion criteria: (a) Previous diagnosis of breast cancer; (b) age 18 years or more; (c) previous treatment with chemotherapy for breast cancer at the Mater Cancer Care Centre, Brisbane; (d) completion of all major cancer treatments (such as surgery, chemotherapy, and radiotherapy) 6 to 60 months before participating in the research; (e) no current or anticipated cancer treatments apart from hormonal medications, if prescribed; (f) self-reported cognitive complaints; and (g) ability to speak, read, and write English fluently.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria will be used: (a) Childhood cancer history; (b) known primary or secondary tumour involving the central nervous system; (c) history of intracranial radiotherapy or intrathecal chemotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will receive the same treatment, after giving informed consent (single-arm study)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Repeated measures t-tests for pre-post comparisons; Effect size calculations; Frequencies for analysis of participant satisfaction. Previous studies of ReCog have found within-group effect sizes of Cohen’s d = 0.5 to 1.5 for changes pre to post intervention on objective and subjective cognitive measures that show statistically significant effects. To detect an effect at the lower end of this range (d = 0.5), 27 participants tested in a pre-post design would give power of 80% to detect the effect (one-tailed testing, alpha = 0.05).

Recruitment
Recruitment status
Completed
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)
QLD
Recruitment hospital [1] 3426 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 9191 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 290699 0
Charities/Societies/Foundations
Name [1] 290699 0
Mater Foundation
Address [1] 290699 0
580 Stanley Street, South Brisbane QLD 4101 Australia
Country [1] 290699 0
Australia
Funding source category [2] 290700 0
University
Name [2] 290700 0
Griffith University
Address [2] 290700 0
Gold Coast campus, Parklands Drive, Southport Qld 4101
Country [2] 290700 0
Australia
Funding source category [3] 297135 0
Government body
Name [3] 297135 0
Department of Science, Information Technology and Innovation, Queensland Government
Address [3] 297135 0
GPO Box 5078, Brisbane 4001
Country [3] 297135 0
Australia
Primary sponsor type
Individual
Name
Dr Heather Green
Address
School of Applied Psychology, Gold Coast campus, Griffith University, Parklands Drive, Southport Qld 4101
Country
Australia
Secondary sponsor category [1] 289391 0
None
Name [1] 289391 0
Address [1] 289391 0
Country [1] 289391 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292336 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 292336 0
Room 294
Level 2 Aubigny Place
Raymond Terrace
South Brisbane
QLD, 4101
Ethics committee country [1] 292336 0
Australia
Date submitted for ethics approval [1] 292336 0
30/01/2015
Approval date [1] 292336 0
26/03/2015
Ethics approval number [1] 292336 0

Summary
Brief summary
This study will determine whether a cognitive rehabilitation intervention, ReCog, has an effect on cognitive function in cancer survivors.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have had a previous diagnosis of breast cancer, had chemotherapy treatment at Mater Cancer Care Centre, Brisbane, and completed all major cancer treatments.

Study details
All participants in this study will receive a group education and skills training intervention called “Responding to Cognitive Concerns” (ReCog). The program is based on self-regulatory cognitive rehabilitation and cognitive behavioural principles, and employs manuals for clinicians and participants. The program is run in small groups of approximately 4-9 participants. There will be four sessions run at weekly intervals by an occupational therapist and each session will last for 2 hours. Patients will be asked to practise the learnt strategies and skills in and between sessions, with the ultimate goal of generalising these strategies to their everyday life. Home tasks are expected to take approximately 15 minutes per day.

Participants' performance on cognitive tasks (such as tests of memory and attention) will occur before and after the group program. Questionnaires on psychological distress, quality of life, psychological needs and satisfaction will be administered after the group program. It is hypothesised that both their cognitive performance on standard tests and reported everyday cognitive performance on questionnaires will improve.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54722 0
Dr Heather Green
Address 54722 0
School of Applied Psychology, Gold Coast campus, Griffith University, Parklands Drive, Southport Qld 4101
Country 54722 0
Australia
Phone 54722 0
+61(0)7 56789086
Fax 54722 0
Email 54722 0
h.green@griffith.edu.au
Contact person for public queries
Name 54723 0
Dr Heather Green
Address 54723 0
School of Applied Psychology, Gold Coast campus, Griffith University, Parklands Drive, Southport Qld 4101
Country 54723 0
Australia
Phone 54723 0
+61(0)7 56789086
Fax 54723 0
Email 54723 0
h.green@griffith.edu.au
Contact person for scientific queries
Name 54724 0
Dr Heather Green
Address 54724 0
School of Applied Psychology, Gold Coast campus, Griffith University, Parklands Drive, Southport Qld 4101
Country 54724 0
Australia
Phone 54724 0
+61(0)7 56789086
Fax 54724 0
Email 54724 0
h.green@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary