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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
Scientific title
Development and Piloting of an Individual Adaptation of Manualised Group Cognitive Rehabilitation for Adult Cancer Survivors
Secondary ID [1] 304938 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Decline 322241 0
Cancer 322788 0
Condition category
Condition code
Cancer 319930 319930 0 0
Any cancer
Mental Health 319931 319931 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 320783 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 327805 0
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Cognitive Function 8a (PROMIS-CF) self-report measure
Timepoint [1] 327805 0
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.
Primary outcome [2] 328217 0
PROMIS Short Form v2.0 Cognitive Function Abilities Subset 8a (PROMIS-CFA) self-report measure
Timepoint [2] 328217 0
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.
Secondary outcome [1] 396657 0
PROMIS Item Bank v1.0 Emotional Distress Depression Short Form 8a
Timepoint [1] 396657 0
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)
Secondary outcome [2] 398102 0
PROMIS Item Bank v1.0 Emotional Distress Anxiety Short Form 8a self-report measure
Timepoint [2] 398102 0
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)
Secondary outcome [3] 398103 0
PROMIS Item Bank v1.0 Fatigue Short Form 8a self-report measure
Timepoint [3] 398103 0
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)
Secondary outcome [4] 398104 0
PROMIS Item Bank v1.0 – Sleep Disturbance – Short Form 8b self-report measure
Timepoint [4] 398104 0
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)
Secondary outcome [5] 398105 0
ReCog-I Intervention Program Participant Satisfaction Survey (designed specifically for this study and previous ReCog/eReCog studies)
Timepoint [5] 398105 0
At the last time point (after the final intervention session)

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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 was conducted by researcher separate from the primary team who was "off-site".
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Reliable change and visual analysis of graphed data was used to evaluate the effectiveness of this program.

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

Funding & Sponsors
Funding source category [1] 308784 0
University
Name [1] 308784 0
Griffith University
Address [1] 308784 0
1 Parklands Drive, Southport QLD 4218
Country [1] 308784 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
1 Parklands Drive, Southport QLD 4218
Country
Australia
Secondary sponsor category [1] 309694 0
None
Name [1] 309694 0
Address [1] 309694 0
Country [1] 309694 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308697 0
Griffith University; Griffith University Human Research Ethics Committee
Ethics committee address [1] 308697 0
1 Parklands Drive, Southport QLD 4215
Ethics committee country [1] 308697 0
Australia
Date submitted for ethics approval [1] 308697 0
28/08/2019
Approval date [1] 308697 0
08/11/2019
Ethics approval number [1] 308697 0
2019/809

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111594 0
Miss Chantelle Pin
Address 111594 0
Griffith University, 1 Parklands Drive, Southport QLD 4215
Country 111594 0
Australia
Phone 111594 0
+61 452525783
Fax 111594 0
Email 111594 0
chantellepin@windowslive.com
Contact person for public queries
Name 111595 0
Dr Heather Green
Address 111595 0
Griffith University, 1 Parklands Drive, Southport QLD 4215
Country 111595 0
Australia
Phone 111595 0
+610756789086
Fax 111595 0
Email 111595 0
h.green@griffith.edu.au
Contact person for scientific queries
Name 111596 0
Dr Heather Green
Address 111596 0
Griffith University, 1 Parklands Drive, Southport QLD 4215
Country 111596 0
Australia
Phone 111596 0
+610756789086
Fax 111596 0
Email 111596 0
h.green@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
Results indicated delivery of ReCogI within individual practice is achievable. Participants reported satisfaction with the content and delivery style of this program and reported one-on-one sessions are valuable due to the versatility and individualised approach. This satisfaction was higher than some small-group delivery (Green et al., 2017) and similar to web-based delivery (Mihuta et al., 2017). Participant outcomes on measure feedback was not commented on in the satisfaction survey. There is also evidence of reliable and clinical change for all participants in at least two perceived symptoms. However, a larger sample in required to ensure this program can be generalised to a diverse population. Overall, this research indicates that ReCogI shows promising preliminary evidence for assisting adult cancer survivors who experience cancer-related cognitive impairment.