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Trial registered on ANZCTR
Registration number
ACTRN12621001015831
Ethics application status
Approved
Date submitted
14/06/2021
Date registered
4/08/2021
Date last updated
4/08/2021
Date data sharing statement initially provided
4/08/2021
Date results information initially provided
4/08/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Efficacy of individual cognitive rehabilitation for adult cancer survivors: A pilot study
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Scientific title
Development and Piloting of an Individual Adaptation of Manualised Group Cognitive Rehabilitation for Adult Cancer Survivors
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Secondary ID [1]
304938
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cognitive Decline
322241
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Cancer
322788
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Condition category
Condition code
Cancer
319930
319930
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0
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Any cancer
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Mental Health
319931
319931
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention to be used is a manualised education and skills training intervention that is designed to be delivered by an appropriately trained and qualified health professional (e.g., psychologist or occupational therapist). The intervention was delivered in 4 one-hour sessions (one-on-one face-to-face and individual online sessions) delivered at weekly intervals facilitated by a provisional psychologist under the supervision of a clinical psychologist. The procedures and manuals for the intervention have been adapted from the existing and previously trialled versions of the "Responding to Cognitive Concerns (ReCog)" intervention. Participants are randomly allocated to either a three- or four-week baseline whereby they complete the cognitive measures at baseline 1 and then the anxiety, depression, sleep, and fatigue measures at all other baselines. Participants then took part in within-session activities and between-session homework tasks (e.g., relaxation practice, applying memory strategies, and applying attention strategies)von the following topics: (1) Ageing, Health, Cancer, and Cognitive Function (2) Memory (3) Attention (4) Fatigue, Emotions, and Cognition.
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Intervention code [1]
320783
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Treatment: Other
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Comparator / control treatment
Participants act as their own control during a randomly allocated baseline period of 3 or 4 weeks prior to receiving the intervention whereby they complete cognitive measures each week.
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Control group
Active
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Outcomes
Primary outcome [1]
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Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Cognitive Function 8a (PROMIS-CF) self-report measure
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Assessment method [1]
327805
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Timepoint [1]
327805
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3 or 4 timepoints prior to commencing intervention dependent on which baseline the participant is allocated, each occurring seven days apart. Then completed each week of the intervention being implemented seven days apart for four intervention modules.
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Primary outcome [2]
328217
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PROMIS Short Form v2.0 Cognitive Function Abilities Subset 8a (PROMIS-CFA) self-report measure
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Assessment method [2]
328217
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Timepoint [2]
328217
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3 or 4 timepoints prior to commencing intervention dependent on which baseline the participant is allocated, each occurring seven days apart. Then completed each week of the intervention being implemented seven days apart for four intervention modules.
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Secondary outcome [1]
396657
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PROMIS Item Bank v1.0 Emotional Distress Depression Short Form 8a
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Assessment method [1]
396657
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Timepoint [1]
396657
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Completed at initial time point (three or four weeks prior to commencing the intervention) and then at the last time point (after the final intervention session)
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Secondary outcome [2]
398102
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PROMIS Item Bank v1.0 Emotional Distress Anxiety Short Form 8a self-report measure
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Assessment method [2]
398102
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Timepoint [2]
398102
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Completed at initial time point (three or four weeks prior to commencing the intervention) and then at the last time point (after the final intervention session)
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Secondary outcome [3]
398103
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PROMIS Item Bank v1.0 Fatigue Short Form 8a self-report measure
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Assessment method [3]
398103
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Timepoint [3]
398103
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Completed at initial time point (three or four weeks prior to commencing the intervention) and then at the last time point (after the final intervention session)
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Secondary outcome [4]
398104
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PROMIS Item Bank v1.0 – Sleep Disturbance – Short Form 8b self-report measure
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Assessment method [4]
398104
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Timepoint [4]
398104
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Completed at initial time point (three or four weeks prior to commencing the intervention) and then at the last time point (after the final intervention session)
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Secondary outcome [5]
398105
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ReCog-I Intervention Program Participant Satisfaction Survey (designed specifically for this study and previous ReCog/eReCog studies)
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Assessment method [5]
398105
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Timepoint [5]
398105
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At the last time point (after the final intervention session)
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Eligibility
Key inclusion criteria
Inclusion criteria are: 18 years and older; fluent in English; previous diagnosis of adult-onset cancer; completion of primary treatments such as surgery, chemotherapy, and radiotherapy; and on a stable dose for at least 2 months for any long-term medication, such as hormonal or targeted therapies.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria are: childhood cancer history; known primary or secondary central nervous system tumour; current mental disorder that would interfere with the ability to give informed consent and/or participate in the intervention; and history of intracranial radiotherapy or intrathecal chemotherapy.
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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 was conducted by researcher separate from the primary team who was "off-site".
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant was randomly allocated to either three or four weeks of baseline assessment using computer generated random allocation sequence. This was held by a separate researcher and revealed for each participant only after eligibility was confirmed, to avoid unconscious bias in screening and consent processes.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Each participant was randomly allocated to either three or four weeks of baseline assessment using computer generated random allocation sequence. This was held by a separate researcher and revealed for each participant only after eligibility was confirmed, to avoid unconscious bias in screening and consent processes. The baseline period enabled participants to act as their own control prior to the delivery of the intervention.
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Reliable change and visual analysis of graphed data was used to evaluate the effectiveness of this program.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
14/02/2020
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Date of last participant enrolment
Anticipated
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Actual
17/07/2020
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Date of last data collection
Anticipated
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Actual
29/08/2020
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Sample size
Target
4
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Accrual to date
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Final
4
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
308784
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University
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Name [1]
308784
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Griffith University
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Address [1]
308784
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1 Parklands Drive, Southport QLD 4218
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Country [1]
308784
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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
1 Parklands Drive, Southport QLD 4218
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Country
Australia
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Secondary sponsor category [1]
309694
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None
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Name [1]
309694
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Address [1]
309694
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Country [1]
309694
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308697
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Griffith University; Griffith University Human Research Ethics Committee
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Ethics committee address [1]
308697
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1 Parklands Drive, Southport QLD 4215
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Ethics committee country [1]
308697
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Australia
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Date submitted for ethics approval [1]
308697
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28/08/2019
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Approval date [1]
308697
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08/11/2019
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Ethics approval number [1]
308697
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2019/809
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Summary
Brief summary
Some people who have been treated for non-central nervous system cancers experience problems with cognitive function during and/or after treatment. In this project, an education and skills intervention that was previously delivered successfully for this population by psychologists or occupational therapists in small group format (Responding to Cognitive Concerns, ReCog) and individual online format (eReCog) will be adapted for individual face-to-face delivery by appropriate professionals (ReCog-I) and piloted with a small number of people who have been treated for cancer. This research aims to gather initial evidence about whether the ReCog-I program has an influence on perceived cognitive function and mental health in participants who have been treated for cancer.
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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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Miss Chantelle Pin
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Address
111594
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Griffith University, 1 Parklands Drive, Southport QLD 4215
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Country
111594
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Australia
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Phone
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+61 452525783
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Fax
111594
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Email
111594
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[email protected]
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Contact person for public queries
Name
111595
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Dr Heather Green
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Address
111595
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Griffith University, 1 Parklands Drive, Southport QLD 4215
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Country
111595
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Australia
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Phone
111595
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+610756789086
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Fax
111595
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Email
111595
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[email protected]
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Contact person for scientific queries
Name
111596
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Dr Heather Green
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Address
111596
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Griffith University, 1 Parklands Drive, Southport QLD 4215
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Country
111596
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Australia
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Phone
111596
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+610756789086
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Fax
111596
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Email
111596
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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)?
No
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No/undecided IPD sharing reason/comment
This is a small sample size project and for privacy reasons it is not planned to make data publicly available.
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What supporting documents are/will be available?
No Supporting Document Provided
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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