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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
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Scientific title
The psychological impact of cognitive rehabilitation and neuropsychological feedback in addressing self-reported cognitive impairment in breast cancer survivors: Randomised pilot study
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Secondary ID [1]
302655
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Nil known
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Universal Trial Number (UTN)
U1111-1260-5196
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Trial acronym
ReCogFP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast cancer
319563
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Condition category
Condition code
Cancer
317506
317506
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0
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Breast
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
318942
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Treatment: Other
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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).
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Control group
Active
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Outcomes
Primary outcome [1]
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Self-reported cognitive impairment on Perceived Cognitive Impairments subscale from Functional Assessment of Cancer Therapy – Version 3
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Assessment method [1]
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Timepoint [1]
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Baseline (pre-intervention), 1 week after receiving feedback, 5 weeks after receiving feedback (primary timepoint), and 5 months after receiving feedback
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Secondary outcome [1]
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PROMIS SF 1.0 Depression 8a
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Assessment method [1]
388339
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Timepoint [1]
388339
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Baseline (pre-intervention), 5 weeks after receiving feedback, and 5 months after baseline
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Secondary outcome [2]
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PROMIS SF 1.0 Anxiety 8a
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Assessment method [2]
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Timepoint [2]
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Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
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Secondary outcome [3]
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PROMIS SF 1.0 Fatigue 8a
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Assessment method [3]
388341
0
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Timepoint [3]
388341
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Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
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Secondary outcome [4]
388342
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PROMIS SF 1.0 Sleep 8b
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Assessment method [4]
388342
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Timepoint [4]
388342
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Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
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Secondary outcome [5]
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Self-reported cognitive function on FACT-Cog-3 subscales of Perceived Cognitive Abilities, Comments from Others, Impact on Quality of Life
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Assessment method [5]
388343
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Timepoint [5]
388343
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Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
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Secondary outcome [6]
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Self-reported prospective memory on Brief Assessment of Prospective Memory
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Assessment method [6]
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Timepoint [6]
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Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
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Secondary outcome [7]
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Health-related quality of life on EQ-5D-5L
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Assessment method [7]
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Timepoint [7]
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Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
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Secondary outcome [8]
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Health-related quality of life on EORTC-QLQ-C30
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Assessment method [8]
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Timepoint [8]
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Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
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Secondary outcome [9]
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Activity and social role participation: Total score on WHO-DAS 2.0
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Assessment method [9]
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Timepoint [9]
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Baseline, 5 weeks after receiving feedback, and 5 months after receiving feedback
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Secondary outcome [10]
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Intervention participant experiences of receiving feedback, as provided during a 30-50 minute semi-structured interview with a research assistant via telephone
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Assessment method [10]
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Timepoint [10]
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2 weeks after receiving feedback
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with stratification for hormone therapy present/absent
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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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
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
11/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2021
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Actual
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Sample size
Target
40
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Accrual to date
26
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
31776
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4215 - Southport
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Griffith University
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Address [1]
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Gold Coast campus, Parklands Drive
Griffith University Qld 4222
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Country [1]
307091
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Australia
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Primary sponsor type
University
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Name
Griffith University
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Address
School of Applied Psychology
Gold Coast campus
Griffith University Qld 4222
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Country
Australia
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Secondary sponsor category [1]
307662
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None
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Name [1]
307662
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Address [1]
307662
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Country [1]
307662
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Other collaborator category [1]
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Hospital
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Name [1]
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Gold Coast Hospital and Health Service
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Address [1]
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Gold Coast University Hospital and Health Service
Parklands Drive
Southport Qld 4215
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Country [1]
281524
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
307207
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Gold Coast Hospital and Health Service Human Research Ethics Committe
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Ethics committee address [1]
307207
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Office for Research Governance and Development
Level 2, Pathology and Education Building
1 Hospital Boulevard
Southport Qld 4215
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Ethics committee country [1]
307207
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Australia
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Date submitted for ethics approval [1]
307207
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Approval date [1]
307207
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14/06/2018
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Ethics approval number [1]
307207
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HREC/18/QGC/130
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Ethics committee name [2]
307210
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Griffith University Human Research Ethics Committee
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Ethics committee address [2]
307210
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Office for Research
Bray Centre (N54)
Nathan campus
Griffith University Qld 4111
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Ethics committee country [2]
307210
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Australia
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Date submitted for ethics approval [2]
307210
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Approval date [2]
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10/04/2019
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Ethics approval number [2]
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2019/277
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Heather Green
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Address
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School of Applied Psychology
Gold Coast campus
Griffith University Qld 4222
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Country
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Australia
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Phone
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+61 7 5678 9086
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Heather Green
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Address
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School of Applied Psychology
Gold Coast campus
Griffith University Qld 4222
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Country
106411
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Australia
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Phone
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+61 7 5678 9086
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Fax
106411
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Heather Green
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Address
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School of Applied Psychology
Gold Coast campus
Griffith University Qld 4222
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Country
106412
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Australia
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Phone
106412
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+61 7 5678 9086
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Fax
106412
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual participant data underlying published results
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When will data be available (start and end dates)?
Immediately after publication for 5 years after the date of publication
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Available to whom?
Available on a case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
Available on a case-by-case basis at the discretion of Primary Sponsor
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How or where can data be obtained?
Access subject to approvals by Principal Investigator, contact
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
9571
Study protocol
[email protected]
9572
Informed consent form
[email protected]
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.
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