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Trial registered on ANZCTR


Registration number
ACTRN12621000238875
Ethics application status
Approved
Date submitted
29/10/2020
Date registered
8/03/2021
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Receiving feedback about thinking and memory problems experienced by cancer survivors: Randomised pilot study
Scientific title
The psychological impact of cognitive rehabilitation and neuropsychological feedback in addressing self-reported cognitive impairment in breast cancer survivors: Randomised pilot study
Secondary ID [1] 302655 0
Nil known
Universal Trial Number (UTN)
U1111-1260-5196
Trial acronym
ReCogFP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 319563 0
Condition category
Condition code
Cancer 317506 317506 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neuropsychological assessment and feedback. Assessment = (1) telephone screening interview with research assistant (20 minutes), (2) completion of WebNeuro online cognitive assessment (40 minutes), (3) completion of self-report measures online (40 minutes). The 3 assessment components can be completed on different days if preferred by the participant. Feedback = 50 minute telephone discussion of personal results and their implications from provisional psychologist or registered psychologist, followed by emailed 2 page summary of results discussed during the telephone call. Feedback is provided approximately one week after the final assessment component is completed.
Intervention code [1] 318942 0
Treatment: Other
Comparator / control treatment
Neuropsychological assessment only. Assessment = telephone screening interview with research assistant (20 minutes), completion of WebNeuro online cognitive assessment (40 minutes), completion of self-report measures online (40 minutes).
Control group
Active

Outcomes
Primary outcome [1] 325540 0
Self-reported cognitive impairment on Perceived Cognitive Impairments subscale from Functional Assessment of Cancer Therapy – Version 3
Timepoint [1] 325540 0
Baseline (pre-intervention), 1 week after receiving feedback, 5 weeks after receiving feedback (primary timepoint), and 5 months after receiving feedback
Secondary outcome [1] 388339 0
PROMIS SF 1.0 Depression 8a
Timepoint [1] 388339 0
Baseline (pre-intervention), 5 weeks after receiving feedback, and 5 months after baseline
Secondary outcome [2] 388340 0
PROMIS SF 1.0 Anxiety 8a
Timepoint [2] 388340 0
Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
Secondary outcome [3] 388341 0
PROMIS SF 1.0 Fatigue 8a
Timepoint [3] 388341 0
Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
Secondary outcome [4] 388342 0
PROMIS SF 1.0 Sleep 8b
Timepoint [4] 388342 0
Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
Secondary outcome [5] 388343 0
Self-reported cognitive function on FACT-Cog-3 subscales of Perceived Cognitive Abilities, Comments from Others, Impact on Quality of Life
Timepoint [5] 388343 0
Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
Secondary outcome [6] 388344 0
Self-reported prospective memory on Brief Assessment of Prospective Memory
Timepoint [6] 388344 0
Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
Secondary outcome [7] 388345 0
Health-related quality of life on EQ-5D-5L
Timepoint [7] 388345 0
Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
Secondary outcome [8] 388346 0
Health-related quality of life on EORTC-QLQ-C30
Timepoint [8] 388346 0
Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
Secondary outcome [9] 388347 0
Activity and social role participation: Total score on WHO-DAS 2.0
Timepoint [9] 388347 0
Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
Secondary outcome [10] 388348 0
Intervention participant experiences of receiving feedback, as provided during a 30-50 minute semi-structured interview with a research assistant via telephone
Timepoint [10] 388348 0
2 weeks after receiving feedback

Eligibility
Key inclusion criteria
Women greater than or equal to 18 years, completed adjuvant chemotherapy for breast cancer within past 36 months, self-report cognitive impairment in the past 7 days on the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire, attribute cognitive dysfunction to cancer and/or cancer treatment, speak and read English fluently, have access to a computer with internet access and an active email account
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Ongoing cancer treatment (ongoing Herceptin or similar targeted therapies, or hormonal therapies are allowable if on stable dose for at least 2 months), history of neurological disorder, current psychiatric disorder that would interfere with study participation

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 involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with stratification for hormone therapy present/absent
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Qualitative component: Semi-structured telephone interview 30-50 minutes in length conducted within one week of feedback session, for participants in intervention arm, to assess participant experiences of receiving feedback
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To obtain 80% power for detecting a medium effect size of group difference across time, requires 20 participants per arm (a=0.05, within-subject rho=0.8). Effect sizes for primary and secondary outcomes will be computed for time, treatment, and treatment by time interactions using Generalised Linear Mixed Models. For qualitative analyses, participant responses are expected to be relatively homogeneous and therefore require about 15-20 participants to reach saturation of themes.

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)
QLD
Recruitment hospital [1] 17913 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 31776 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 307091 0
University
Name [1] 307091 0
Griffith University
Address [1] 307091 0
Gold Coast campus, Parklands Drive
Griffith University Qld 4222
Country [1] 307091 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
School of Applied Psychology
Gold Coast campus
Griffith University Qld 4222
Country
Australia
Secondary sponsor category [1] 307662 0
None
Name [1] 307662 0
Address [1] 307662 0
Country [1] 307662 0
Other collaborator category [1] 281524 0
Hospital
Name [1] 281524 0
Gold Coast Hospital and Health Service
Address [1] 281524 0
Gold Coast University Hospital and Health Service
Parklands Drive
Southport Qld 4215
Country [1] 281524 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307207 0
Gold Coast Hospital and Health Service Human Research Ethics Committe
Ethics committee address [1] 307207 0
Office for Research Governance and Development
Level 2, Pathology and Education Building
1 Hospital Boulevard
Southport Qld 4215
Ethics committee country [1] 307207 0
Australia
Date submitted for ethics approval [1] 307207 0
Approval date [1] 307207 0
14/06/2018
Ethics approval number [1] 307207 0
HREC/18/QGC/130
Ethics committee name [2] 307210 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 307210 0
Office for Research
Bray Centre (N54)
Nathan campus
Griffith University Qld 4111
Ethics committee country [2] 307210 0
Australia
Date submitted for ethics approval [2] 307210 0
Approval date [2] 307210 0
10/04/2019
Ethics approval number [2] 307210 0
2019/277

Summary
Brief summary
This trial is investigating the efficacy of providing neuropsychological feedback in addressing self-reported cognitive impairment in breast cancer survivors.

Who is it for?
You may be eligible for this trial if you are a female over the age of 18 who has completed adjuvant chemotherapy for breast cancer within past 36 months and have self-reported cognitive dysfunction attributed to cancer and/or cancer treatment.

Study details
Participants will be randomly allocated to either the intervention arm or the control arm.
Intervention: Participants will undertake a screening interview, online cognitive assessment and complete questionnaires related to cognitive performance and health. They will then receive feedback on their results and discuss implications with a psychologist over the phone.
Control: Participants will undertake a screening interview, online cognitive assessment and complete questionnaires related to cognitive performance and health.

Information from this study will be used to plan future intervention studies about the impact of feedback on perceived cognitive impairment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106410 0
Dr Heather Green
Address 106410 0
School of Applied Psychology
Gold Coast campus
Griffith University Qld 4222
Country 106410 0
Australia
Phone 106410 0
+61 7 5678 9086
Fax 106410 0
Email 106410 0
h.green@griffith.edu.au
Contact person for public queries
Name 106411 0
Dr Heather Green
Address 106411 0
School of Applied Psychology
Gold Coast campus
Griffith University Qld 4222
Country 106411 0
Australia
Phone 106411 0
+61 7 5678 9086
Fax 106411 0
Email 106411 0
h.green@griffith.edu.au
Contact person for scientific queries
Name 106412 0
Dr Heather Green
Address 106412 0
School of Applied Psychology
Gold Coast campus
Griffith University Qld 4222
Country 106412 0
Australia
Phone 106412 0
+61 7 5678 9086
Fax 106412 0
Email 106412 0
h.green@griffith.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?
De-identified individual participant data underlying published results
When will data be available (start and end dates)?
Immediately after publication for 5 years after the date of publication
Available to whom?
Available on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Available on a case-by-case basis at the discretion of Primary Sponsor
How or where can data be obtained?
Access subject to approvals by Principal Investigator, contact h.green@griffith.edu.au
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 9571 0
Study protocol
Citation [1] 9571 0
Link [1] 9571 0
Email [1] 9571 0
h.green@griffith.edu.au
Other [1] 9571 0
Attachment [1] 9571 0
Type [2] 9572 0
Informed consent form
Citation [2] 9572 0
Link [2] 9572 0
Email [2] 9572 0
h.green@griffith.edu.au
Other [2] 9572 0
Attachment [2] 9572 0
Summary results
No Results