Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000189729
Ethics application status
Approved
Date submitted
20/01/2022
Date registered
3/02/2022
Date last updated
18/11/2022
Date data sharing statement initially provided
3/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Group cognitive rehabilitation via telehealth for brain cancer
Scientific title
Evaluation of an online group program targeting management of everyday memory and thinking problems of brain cancer survivors
Secondary ID [1] 305556 0
None
Universal Trial Number (UTN)
Trial acronym
BRAINS LaTCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive difficulties associated with brain cancer 324711 0
Condition category
Condition code
Mental Health 322159 322159 0 0
Studies of normal psychology, cognitive function and behaviour
Cancer 322480 322480 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the impact of the LaTCH (La Trobe – Caulfield Hospital) memory program on the wellbeing of adult brain cancer survivors through a randomised control trial, hybrid implementation, design. This method allows for the primary aim of determining the effectiveness of the LaTCH intervention, with a concurrent secondary aim of gathering information to better understand the context for future implementation of the intervention.

Intervention - The LaTCH Program
The LaTCH program provides psychoeducation, practical advice, and strategies for coping with the memory and thinking difficulties encountered in everyday life following cancer diagnosis and treatment. The program incorporates didactic presentations, interactive group activities (e.g. brainstorming), and short video presentations (e.g. vignettes of memory difficulties and memory strategies). It consists of 6 x 2-hour, weekly interactive group sessions covering the following topics:

Session 1
Describing common memory problems and frustrations.
Memory stores (working memory, recently acquired memories and remote memories) are described and participants give examples of some aspects of memory. Prospective memory and forgetting are explained.
Memory processes (registration, retention, retrieval) are described and ideas about enhancing these are discussed with input from the group.
Ways of dealing with memory problems are described.

Session 2
Cognition and cancer - Description of the causes of normal memory/ cognitive lapses due to cancer; cancer treatment; and associated factors, and older age (if relevant to group). Explanation of the cumulative effect of these causes.
Active learning techniques, incorporating explanation, illustration, and demonstration.

Session 3
Remembering Tasks - discuss different types of Prospective Memory tasks and the different solutions that are suitable for each.
Using external memory aids.

Session 4
Review of content covered so far.
Responding to memory difficulties in conversation.
Active learning techniques, incorporating explanation, illustration, and demonstration.
Approaches to learning to use new technology.

Session 5
Remembering non-verbal information.
Losing belongings.
Concentration, organisation, and routines.
Unwinding and staying calm.
Navigating to new places.

Session 6
Keeping Your Brain Healthy - factors shown to affect cognitive function; diet, exercise, health checks, depression/anxiety, sleep.
Review personal memory goals.

Booster
Revision of keys points from each session.
Review personal memory goals.


LaTCH has been shown to improve cognitive strategy knowledge/use, well-being and self-reported memory ability in samples of healthy ageing Australians (ACTRN12620000979954), in those with mild cognitive impairment (trial not registered), and in cancer survivors (trial not registered). However, it has not yet been used exclusively with survivors of brain cancer. A recent pilot trial of this face-to-face group for cancer survivors (N=10; 60% brain cancer) at Olivia Newton John centre, Austin Health (HREC/46115/2018), provided preliminary evidence of efficacy, with large effect sizes found in relation to pre-post changes in goals, perceived cognition, memory strategy use, memory contentment, and emotional well-being. Recruitment of a sufficient number of brain cancer patients from a single site was challenging, and a telehealth model will enable nationwide recruitment and reduce access barriers, especially in the context of the current pandemic. Of note, the LaTCH program has recently been successfully adapted for telehealth delivery in patients with mild cognitive impairment (MCI) (Mullaly & Rand, 2021).

The LaTCH program intervention will be conducted online via zoom with between 10-12 groups of participants (approximately 4-5 participants per group, totalling 50 participants overall). The intervention sessions for each group will occur over a 6-week period and may run concurrently or consecutively, depending on facilitator schedules and participant recruitment rates. A reminder email will be sent to each participant several days in advance of each session. Participant attendance at each session will be recorded by the facilitator. If a participant does not attend a session, they will be contacted by email by the researchers to enquire if they wish to remain in the program or withdraw. If a participant elects to withdraw, they will asked to complete a brief online ‘Withdrawal of Consent’ form, nominating their reason for withdrawing.

Block randomisation of participant groups will occur once 8-10 participants have been recruited. Wherein 4-5 participants will be randomly allocated to either the intervention or waitlist. One to two weeks prior to participation, a member of the research team will make contact with each participant in a given group to administer the pre-assessment (baseline) measures. The intervention groups will meet weekly via zoom for six weeks to participate in the 2-hour sessions of LaTCH. The LaTCH facilitators will be either trained members of the research team or, to enhance future implementation likelihood, relevant health professionals will be trained as facilitators (i.e., interested brain cancer coordinators). At the end of the first LaTCH session, participants will generate personal functional memory goals with the assistance of the LaTCH facilitator. This was evidenced in the 2019 LaTCH pilot to be the most effective timepoint for goal generation because participants have acquired an understanding of the content and focus of LaTCH. Following the conclusion of the six sessions, the outcome measures will be re-administered to both the waitlist and intervention groups (utilising the same format as the pre-intervention).

Intervention-group participants will return six weeks after the completion of the LaTCH program for a 90-minute booster session. Following the conclusion of the booster session, the outcome measures will be re-administered to both the waitlist and intervention groups (utilising the same format as the pre-intervention). Participants in the intervention group will also complete the post-intervention semi-structured interview with a member of the research team. Inclusion of this third outcome measures testing point allows for both the assessment of the longitudinal maintenance of LaTCH and any further implementation information that participants could provide following utilisation of LaTCH in their everyday lives. This also provides the ability for the research team to monitor participants’ change in cognition over time.

The waitlist groups will be offered the intervention after their respective intervention group have completed the intervention (6-week LaTCH program and 6-week post-booster session). Inclusion of 4-5 paired intervention/waitlist control groups will allow us to determine if the LaTCH program contributes to any improvements in subjective cognitive ability and well-being.
Intervention code [1] 322471 0
Treatment: Other
Comparator / control treatment
Wait-list control group.
Control group
Active

Outcomes
Primary outcome [1] 329929 0
Primary outcome – subjective cognition (Perceived memory ability, strategy use and contentment)
Measure: Multifactorial Memory Questionnaire (Troyer & Rich, 2002)
Timepoint [1] 329929 0
Assessments across all outcome measures will take place at three time-points across the study (detailed below). The primary time-point is post-intervention.

Baseline (1-2 weeks prior to intervention commencement)
Post-intervention (1-2 weeks post intervention completion)
Post-booster (1-2 weeks post booster session completion)
Primary outcome [2] 330184 0
Primary outcome – subjective cognition (Perceived cognitive ability)
Measure: Functional Assessment of Cancer Therapy-Cognitive Function (Wagner, Sweet, Butt, & Cella, 2009)
Timepoint [2] 330184 0
Assessments across all outcome measures will take place at three time-points across the study (detailed below). The primary time-point is post-intervention.

Baseline (1-2 weeks prior to intervention commencement)
Post-intervention (1-2 weeks post intervention completion)
Post-booster (1-2 weeks post booster session completion)
Secondary outcome [1] 405171 0
Secondary outcome – emotional wellbeing (Quality of life)

Measure: Functional Assessment of Cancer Therapy-General
(Wagner, Sweet, Butt, & Cella, 2009)
Timepoint [1] 405171 0
Assessments across all outcome measures will take place at three time-points across the study (1-2 weeks prior to intervention commencement, 1-2 weeks post intervention completion, and 1-2 weeks post booster session completion).
Secondary outcome [2] 405172 0
Secondary outcome – emotional wellbeing (fatigue)

Measure: European Organization for Research and Treatment of Cancer – Fatigue (Weis et al., 2017)
Timepoint [2] 405172 0
Assessments across all outcome measures will take place at three time-points across the study (1-2 weeks prior to intervention commencement, 1-2 weeks post intervention completion, and 1-2 weeks post booster session completion).
Secondary outcome [3] 405173 0
Secondary outcome – emotional wellbeing (fatigue)

Measure: Functional Assessment of Cancer Therapy-Fatigue (Wagner, Sweet, Butt, & Cella, 2009)
Timepoint [3] 405173 0
Assessments across all outcome measures will take place at three time-points across the study (1-2 weeks prior to intervention commencement, 1-2 weeks post intervention completion, and 1-2 weeks post booster session completion).
Secondary outcome [4] 405174 0
Secondary outcome – emotional wellbeing (mood)

Measure: Hospital Anxiety and Depression Scale
(Zigmond & Snaith, 1983)
Timepoint [4] 405174 0
Assessments across all outcome measures will take place at three time-points across the study (1-2 weeks prior to intervention commencement, 1-2 weeks post intervention completion, and 1-2 weeks post booster session completion).

Eligibility
Key inclusion criteria
Eligible participants are (a) adult survivors of brain cancer over the age of 18 years old, (b) who are at least three months post diagnosis, and (c) have expressed a desire to take part in the LaTCH program. Participants must fluently read and speak English to participate in the study. Additionally, participants must be available to attend the two-hour LaTCH program sessions and have access to the internet and a computer or tablet to attend the zoom sessions. On formal screening (TELE phone assessment, Gatz et al., 1995), participants will need to obtain a minimum score of 16 following sensitivity/specificity guidelines for identifying cognitive impairment (Gatz et al., 2002).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not have undergone radiation therapy in the month prior to the LaTCH program. Additional exclusion criteria are the presence of severe behavioural disturbances that would preclude appropriate participation in group sessions (e.g., behavioural disinhibition or inappropriateness, aggression, significant emotional lability).

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (www.randomizer.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will examine intervention effects (assessing the primary and secondary objectives) immediately following the intervention and at 3 month follow up using a repeated measures analysis of covariance (ANCOVA), with group (control/intervention) as the between-subjects factor and time as the within-subjects factor (6-week and 3-month). Baseline scores will be used as covariates to control for baseline group differences. We will examine the group effect to determine the effect of the intervention, and the time by group interaction to examine whether intervention effects are maintained.

Personal memory goals will be examined using nonparametric analyses, in order to maintain the ordinal nature of the data; differences between pre and post intervention ratings will be analysed using Wilcoxon signed rank tests.

A qualitative thematic analysis of implementation-focused semi-structured interviews, as well as other related information (e.g., expected/unexpected participation benefits, barriers to participation, concerns that were addressed well/not addressed), will be conducted to determine important commonalities raised by participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
7/10/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
50
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21520 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 21521 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 21522 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 36427 0
3084 - Heidelberg
Recruitment postcode(s) [2] 36428 0
3050 - Parkville
Recruitment postcode(s) [3] 36429 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 309920 0
Government body
Name [1] 309920 0
Department of Health
Country [1] 309920 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Department of Psychology & Counselling
Cnr Plenty Road And Kingsbury Drive
BUNDOORA VIC 3086
Country
Australia
Secondary sponsor category [1] 310951 0
None
Name [1] 310951 0
Address [1] 310951 0
Country [1] 310951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309640 0
Austin Health
Ethics committee address [1] 309640 0
Ethics committee country [1] 309640 0
Australia
Date submitted for ethics approval [1] 309640 0
28/01/2022
Approval date [1] 309640 0
19/09/2022
Ethics approval number [1] 309640 0

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

Contacts
Principal investigator
Name 114870 0
Dr Kerryn Pike
Address 114870 0
La Trobe University
Department of Psychology & Counselling
Cnr Plenty Road And Kingsbury Drive
BUNDOORA VIC 3086
Country 114870 0
Australia
Phone 114870 0
+61 3 9479 1381
Fax 114870 0
Email 114870 0
[email protected]
Contact person for public queries
Name 114871 0
Sian Virtue-Griffiths
Address 114871 0
La Trobe University
Department of Psychology & Counselling
Cnr Plenty Road And Kingsbury Drive
BUNDOORA VIC 3086
Country 114871 0
Australia
Phone 114871 0
+61 0422294248
Fax 114871 0
Email 114871 0
[email protected]
Contact person for scientific queries
Name 114872 0
Kerryn Pike
Address 114872 0
La Trobe University
Department of Psychology & Counselling
Cnr Plenty Road And Kingsbury Drive
BUNDOORA VIC 3086
Country 114872 0
Australia
Phone 114872 0
+61 3 9479 1381
Fax 114872 0
Email 114872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14736Study protocol    Publication is in progress.



Results publications and other study-related documents

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