Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001289303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
14/10/2025
Date registered
Help: Date registered
27/10/2026
Date last updated
Help: Date last updated
27/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
27/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a Trauma-Informed Cognitive Rehabilitation Intervention for Cancer Survivors
Scientific title
Evaluating a Trauma-Informed Cognitive Rehabilitation Intervention for Cancer Survivors to Investigate its Impacts on Self-Reported Cognitive Impairment, Post-Traumatic Stress Symptoms, Depression and Anxiety
Additional trial identifiers [1] 315562 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Self-reported cognitive impairment 339190 0
Depression symptoms 339191 0
Post-traumatic stress symptoms 339192 0
Anxiety symptoms 339193 0
Cancer 339194 0
Condition category
Condition code
Cancer 335465 335465 0 0
Any cancer
Mental Health 335466 335466 0 0
Anxiety
Mental Health 335467 335467 0 0
Depression
Mental Health 335468 335468 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 335469 335469 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Tri-eReCog is a trauma-informed online cognitive rehabilitation intervention aimed at addressing symptoms of self-reported cognitive impairment amongst cancer survivors. It includes five online modules which incorporate psychoeducation, relaxation, strategy training, discussion questions, and homework. The five modules will address topics including (in order of module): ageing, health, cancer and cognitive function; memory; attention; fatigue, emotions and cognition; and distress. Tri-eReCog will be accessed individually by participants via a computer at a location of their choice. The intervention includes 5 x 30–60-minute sessions, once per week for five weeks. Content will be presented using the software LAMS. Participants will log in to the LAMS program and content will be presented as an interactive module that includes text, interactive quizzes, and audio files.

Content will be modified to include more trauma-informed language through the emphasis of the optional nature of the discussion activities, quizzes and homework. For example, under the group discussion activities, there will be the addition of a disclaimer stating that responding to these prompts is completely optional, and participants need only respond if they feel completely comfortable doing so (“Please remember that responding to these prompts is completely optional, and you need only respond if you feel completely comfortable doing so”). Furthermore, at the end of each module, information will be added regarding how participants can seek further help, if they wish to. This will include information on accessing resources such as the Cancer Council, Beyond Blue, Lifeline and emergency services if they feel they are in experiencing an emergency. Moreover, they will be encouraged to contact their general practitioner or another registered health practitioner if they feel they need further support (“If you ever feel that you need to seek further help, please do not hesitate to reach out to any of the below resources: Beyond Blue [call a counsellor using 1300 22 4636; chat to a counsellor online via their website; or get support from the online community via their website]; Lifeline [call using 13 11 14; chat with them online via their website; or text via 0477 13 11 14]; Cancer Council. If you are in an emergency, please do not hesitate to call 000. You can also reach out to a registered health practitioner such as your GP if you would like to seek further help. Finally, please reach out to your support network if you feel you need support.”). Finally, a fifth module will be added regarding distress and trauma, which will include psychoeducation about depression, anxiety and post-traumatic stress symptoms and how this may link to self-reported cognitive impairment.

Intervention adherence will be assessed through the monitoring of adherence and study retention rates by the researchers. Specifically, the LAMS program allows for the researchers to see which participants have completed the modules, and whether they have completed the activities associated with the modules.
Intervention code [1] 332188 0
Treatment: Other
Description of the comparator or control
The control group will be a group of cancer patients with self-reported cognitive impairment and symptoms of distress (anxiety, depression and/or post-traumatic stress symptoms) who do not receive the intervention. The control group will be added to a wait-list and will receive access to the intervention after the final outcome assessment (6-weeks post-randomisation).
Control group
Active

Outcomes
Primary outcome [1] 343026 0
Self-reported cognitive impairment
Timepoint [1] 343026 0
Baseline and immediately post-intervention completion (within 7 days) for the intervention group, 6 weeks post-randomisation for the control group (primary timepoint)
Primary outcome [2] 343027 0
Post-traumatic stress symptoms
Timepoint [2] 343027 0
Baseline and immediately post-intervention completion (within 7 days) for the intervention group, 6 weeks post-randomisation for the control group (primary timepoint)
Primary outcome [3] 343028 0
Anxiety symptoms
Timepoint [3] 343028 0
Baseline and immediately post-intervention completion (within 7 days) for the intervention group, 6 weeks post-randomisation for the control group (primary timepoint)
Secondary outcome [1] 453191 0
Depression symptoms (primary outcome)
Timepoint [1] 453191 0
Baseline and immediately post-intervention completion (within 7 days) for the intervention group, 6 weeks post-randomisation for the control group (primary timepoint)
Secondary outcome [2] 469509 0
Participant satisfaction
Timepoint [2] 469509 0
Immediately post-intervention completion (within 7 days) for the intervention group.

Eligibility
Key inclusion criteria
Key inclusion criteria will consist of a diagnosis of non-central nervous system cancer, complaints of distress symptoms (either post-traumatic stress, depression and/or anxiety symptoms), self-reported cognitive impairment, completion of primary treatment at least 6 months prior to enrolment (excluding ongoing hormone therapy), and no anticipated cancer treatments apart from hormonal medications.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Key exclusion criteria will include central-nervous system related cancer, a lack of English language proficiency that would allow participants to give informed consent and participate in the intervention, and active cancer treatment.

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)
Random number generation in excel
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation in excel
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Fifty participants will be recruited based on pragmatics. This allows for 25 participants per group with an estimated attrition rate of <20% and allows for 20+ per cell which is the minimum for a reasonably stable estimate of standard deviation.

Data will be analysed through a series of 2 (group: intervention and control) x 2 (time: baseline and post-intervention) ANOVAs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2027
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 28640 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 44869 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 320167 0
University
Name [1] 320167 0
Griffith University
Country [1] 320167 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 322723 0
None
Name [1] 322723 0
Address [1] 322723 0
Country [1] 322723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318704 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 318704 0
Ethics committee country [1] 318704 0
Australia
Date submitted for ethics approval [1] 318704 0
16/05/2025
Approval date [1] 318704 0
16/10/2025
Ethics approval number [1] 318704 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 145002 0
Dr Heather Green
Address 145002 0
1 Parklands Dr, Southport, QLD, 4215, Griffith University, Gold Coast Campus, G40 Room 7.99
Country 145002 0
Australia
Phone 145002 0
+61 7 5678 9086
Fax 145002 0
Email 145002 0
[email protected]
Contact person for public queries
Name 145003 0
Heather Green
Address 145003 0
1 Parklands Dr, Southport, QLD, 4215, Griffith University, Gold Coast Campus, G40 Room 7.99
Country 145003 0
Australia
Phone 145003 0
+61 7 5678 9086
Fax 145003 0
Email 145003 0
[email protected]
Contact person for scientific queries
Name 145004 0
Heather Green
Address 145004 0
1 Parklands Dr, Southport, QLD, 4215, Griffith University, Gold Coast Campus, G40 Room 7.99
Country 145004 0
Australia
Phone 145004 0
+61 7 5678 9086
Fax 145004 0
Email 145004 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.