Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000039684
Ethics application status
Approved
Date submitted
12/12/2022
Date registered
13/01/2023
Date last updated
26/11/2023
Date data sharing statement initially provided
13/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
CanCommunicate: Efficacy of optimising communication for people with brain cancer and their families
Scientific title
CanCommunicate: Efficacy of optimising communication for people with brain cancer and their families with group and individual management sessions
Secondary ID [1] 308600 0
None
Universal Trial Number (UTN)
U1111-1286-0398
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain cancer 328477 0
Condition category
Condition code
Cancer 325511 325511 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CanCommunicate will have two key components: component 1 will involve whole-group education sessions and component 2 will involve individual management sessions. The 3 group education sessions will explore the construct of language and communication, common language changes with brain cancer, and effective communication strategies, targeting both the needs of family/friends and the person with the brain tumour to support and optimize their communication. The final group session will focus on skills generalisation within the group context and maintenance of skills in daily life. Each group session will run for approximately one hour, including information provision and discussion/questions, and will occur either face-to-face or via videoconferencing (depending on the participant’s preference). If participants elect for a face-to-face session, the session will occur at the Princess Alexandra Hospital.

The 4 individual sessions will involve a detailed assessment (including case history) and individualised intervention plan by a speech pathologist, strategies, details for freely available communication apps and referrals to other healthcare services as required. The exact nature of the session will be tailored to each participant's needs; however, the basic session structure will involve rapport building (10 mins), standard speech pathology therapy tasks, communication strategies or assessment (40 mins), and recapping the session (10 mins). Each session will last for up to one hour and will occur either face-to-face or via videoconferencing (depending on the participant’s preference). If participants elect for a face-to-face session, the session will occur at the Princess Alexandra Hospital.

All group and individual sessions will be delivered by a qualified speech pathologist. The sessions will be delivered sequentially once per week, with the initial 2 group sessions followed by the 4 individual sessions, and then the final group session. The total intervention duration is approximately 1 hour per week for 7 weeks. Participants will be given the option of having a support person present to assist them with the sessions if required. Adherence to the intervention will be monitored using session attendance checklists.
Intervention code [1] 325047 0
Rehabilitation
Comparator / control treatment
Participants will receive the usual care provided to people with brain cancer at the recruiting hospital by speech pathologists, which will be systematically recorded. This usual care may include assessment of communication function, written information provision about communication changes associated with brain cancer, communication therapy, and referrals to other services. The control group will be offered the intervention after the intervention group completes their 6-week follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 333356 0
Communication disability will be assessed using the Comprehensive Aphasia Test (CAT) Disability Questionnaire (DQ)
Timepoint [1] 333356 0
Baseline, end of the intervention time period (primary endpoint) and 6 weeks later
Secondary outcome [1] 416732 0
Quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G)
Timepoint [1] 416732 0
Baseline, end of the intervention time period, and 6 weeks later
Secondary outcome [2] 416733 0
Participant perceptions of their communication will be assessed using the La Trobe Communication Questionnaire (LCQ)
Timepoint [2] 416733 0
Baseline, end of the intervention time period, and 6 weeks later
Secondary outcome [3] 416734 0
Participant perceptions of their communication function will be explored using a Qualitative Semi-Structured Interview.
Timepoint [3] 416734 0
Baseline, end of the intervention time period, and 6 weeks later
Secondary outcome [4] 416735 0
Participants' communication function will be assessed via a 10 minute conversation. The conversation will be video recorded by the research assistant for subsequent analysis using the Measure of Skill in Supported Conversation (MSC).
Timepoint [4] 416735 0
Baseline, end of the intervention time period, and 6 weeks later
Secondary outcome [5] 417456 0
Participant perceptions of the intervention will be explored using a Qualitative Semi-Structured Interview.
Timepoint [5] 417456 0
End of the intervention time period and 6 weeks later
Secondary outcome [6] 417457 0
Participants' communication function will be assessed via a 10 minute conversation. The conversation will be video recorded by the research assistant for subsequent analysis using the Measure of Participation in Conversation (MPC).
Timepoint [6] 417457 0
Baseline, end of the intervention time period, and 6 weeks later
Secondary outcome [7] 417458 0
Participants' communication function will be assessed via a 10 minute conversation. The conversation will be video recorded by the research assistant for subsequent analysis using conversation analysis (e.g., word finding difficulties, communication breakdowns).
Timepoint [7] 417458 0
Baseline, end of the intervention time period, and 6 weeks later

Eligibility
Key inclusion criteria
Aged 18 years or over, diagnosis of primary brain tumour (including benign, lower-grade glioma and higher-grade glioma) which is consistent with the clinical population seen in the multidisciplinary clinic at the recruiting hospital, post-initial cancer treatment, and able to participate in assessment and intervention sessions (with communication support as required).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis other than primary brain cancer (e.g., brain metastases), comorbid substance abuse or psychiatric disorder not effectively managed, or experiencing rapid deterioration in health which limits engagement in the intervention.

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 will be concealed using opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation in blocks of 10 participants. Randomisation will be stratified according to tumour type (benign, lower grade, high grade). Randomisation (individual level) will occur using a computerised random number generator by an independent researcher who is not part of the research team, with 50:50 assignment to CanCommunicate or usual care. Allocation will be concealed using opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The control group will receive usual care during the 7-week intervention period and will then be offered the intervention after the 6-week follow-up assessment (Total waitlist time between initial and 6 week follow up assessment = 13 weeks). This is to give participants in the control condition the opportunity to participate in the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures mixed models will be used to analyse within and between group differences at T1, T2 and T3 on the CAT DQ, FACT-G, LCQ and conversation analysis (MSC, MPC, breakdowns, word finding difficulties). Analyses will occur blinded to group allocation. Demographic information will be analysed descriptively. Interview transcripts will be analysed using thematic analysis to identity key themes within the data. Themes will be checked and discussed by the research team to ensure rigour.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
14/11/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
84
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23711 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 39147 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 312846 0
Hospital
Name [1] 312846 0
Princess Alexandra Hospital
Country [1] 312846 0
Australia
Primary sponsor type
Individual
Name
Emma Finch
Address
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 314492 0
Hospital
Name [1] 314492 0
Princess Alexandra Hospital
Address [1] 314492 0
199 Ipswich Road
Woolloongabba QLD 4102
Country [1] 314492 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312124 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 312124 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4012
Ethics committee country [1] 312124 0
Australia
Date submitted for ethics approval [1] 312124 0
19/01/2023
Approval date [1] 312124 0
21/02/2023
Ethics approval number [1] 312124 0
92333

Summary
Brief summary
This study will evaluate a tailored communication intervention, developed with people with brain cancer, for people with brain cancer and their families.

Who is it for?
You may be eligible for this study if you are an adult with a diagnosis of a primary brain tumour (including benign, lower-grade glioma and higher-grade glioma).

Study details
Participants will be randomly allocated to either the intervention or control group. The intervention group will have a combination of weekly individual and group sessions focused around communication strategies and resources, delivered by a speech pathologist. The control group will receive usual care by hospital speech pathologists, and will have the opportunity to access the tailored communication intervention once the intervention group have completed their assessments. All participants will be asked to complete questionnaires and interviews assessing their communication function and perception of the intervention over the study period.

It is hoped that findings from this study will help optimise communication treatments for people with brain cancer, where communication impairments are highly prevalent.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123562 0
Dr Emma Finch
Address 123562 0
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 123562 0
Australia
Phone 123562 0
+61 7 3176 9591
Fax 123562 0
Email 123562 0
[email protected]
Contact person for public queries
Name 123563 0
Dr Emma Finch
Address 123563 0
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 123563 0
Australia
Phone 123563 0
+61 7 3176 9591
Fax 123563 0
Email 123563 0
[email protected]
Contact person for scientific queries
Name 123564 0
Dr Emma Finch
Address 123564 0
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 123564 0
Australia
Phone 123564 0
+61 7 3176 9591
Fax 123564 0
Email 123564 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?

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.