Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000453785p
Ethics application status
Submitted, not yet approved
Date submitted
2/11/2021
Date registered
23/03/2022
Date last updated
23/03/2022
Date data sharing statement initially provided
23/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Multidisciplinary brain cancer rehabilitation, holistic assessment, and multimodal interventions to address survivorship needs: Brain Trial
Scientific title
Multidisciplinary brain cancer rehabilitation, holistic assessment, and multimodal interventions to address survivorship needs: Brain Trial Patients
Secondary ID [1] 305714 0
Nil
Universal Trial Number (UTN)
Trial acronym
BRAIN TRIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Cancer 324181 0
Condition category
Condition code
Cancer 321657 321657 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
15 eligible participants (18+ years) and their family/caregiver will be randomly allocated to the needs-based multimodal supportive care intervention. There are four main components to the intervention arm and each participant will receive the following:

(1) Informational Materials
Participants will be provided with an evidence-based information booklet, designed specifically for this study. The booklet will take approximately 10 minutes to read through and will include: how to self-care, managing side-effects, nutrition and exercise, relationships and sexual well-being, healthy lifestyle approaches and community-based supports. Participants can review and refer back to the materials at their own discretion.

(2) Holistic Needs Assessment
Participants will have an individualised, face-to-face session at each out-patient clinical review appointment (total duration of 6 months). The anticipated duration of each session is 30 minutes in length. The Holistic Needs Assessment (HNA) questionnaire will be completed by patients and family/caregiver before the consultation. The information gathered from the HNA will then directly inform an individually tailored self-management care plan. Concerns and problems, as well as realistic goals/expectations will be discussed and any necessary referrals to other multidisciplinary team members will be provided.

(3) Self-Management Care Plans
Self-management care plans will be developed with the participants at the end of the discussion of the HNA and shared with GPs. The self-management care plans may include self-care advice for specific symptom management, along with any lifestyle recommendations that may benefit the individual participant. Each care plan will be reviewed and adjusted (where necessary) by a member of the research team, at the 2, 4 and 6 month follow-up appointments.

(4) Physical Exercise Programme
Exercises will be prescribed based on the needs of each participant, identified by the exercise physiologist and the individual during the initial data collection appointment. Exercises (cardiovascular and/or body weight/resistance) will be tailored to individual needs depending on individual abilities and any existing co-morbidities. The individual exercise programme may be completed at home or in a clinical rehabilitation gym with an exercise physiologist supervisor. Any restrictions and limits on the exercise programme will be based on the needs of each participant, identified by the exercise physiologist and the individual during the initial data collection appointment.

Session attendance checklists will be implemented to assess and monitor adherence to the interventions.
Intervention code [1] 322099 0
Rehabilitation
Comparator / control treatment
15 eligible participants (18+ years) and their family/caregiver will be randomly allocated to the control group consisting of standard care currently available at their clinical site.
Current standard care includes the provision of disease and/or treatment specific information, which is at the discretion of the treating clinician, along with the contact details of the specialist nurse, should the patient require any further information, advice or support.
Control group
Active

Outcomes
Primary outcome [1] 329431 0
Supportive Care Needs Survey (SCNS-34)
Timepoint [1] 329431 0
Patients will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [1] 406105 0
Physical activity outcome:

6-minute walk test
Timepoint [1] 406105 0
Patients will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [2] 406106 0
Physical activity outcome:

30 second sit to stand test
Timepoint [2] 406106 0
Patients will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [3] 406107 0
Physical activity outcome:

Blood pressure and Pulse Wave Velocity, which will be measured using a SphygmoCor device (SphygmoCoR; At-Cor Medical Pty Ltd., Sydney, Australia).
Timepoint [3] 406107 0
Patients will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [4] 406108 0
PROM:

Quality of Life (QLQ-C30 & BN20)
Timepoint [4] 406108 0
Patients will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [5] 406109 0
PROM:

Mental Adjustment to Cancer Scale (coping)
Timepoint [5] 406109 0
Patients will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [6] 406110 0
PROM:

Communication and Attitudinal Self-Efficacy Scale for Cancer (self-efficacy).
Timepoint [6] 406110 0
Patients will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [7] 406111 0
PROM:

Hospital Anxiety and Depression Scale (anxiety and depression)
Timepoint [7] 406111 0
Both patients and partners will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [8] 406112 0
PROM:

Sense of Coherence Scale (coherence)
Timepoint [8] 406112 0
Both patients and partners will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [9] 406113 0
PROM:

Measuring Dyadic Adjustment (couples adjustment)
Timepoint [9] 406113 0
Both patients and partners will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [10] 406114 0
PROM:

Distress Thermometer (distress)
Timepoint [10] 406114 0
Both patients and partners will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [11] 406120 0
PROM:

Supportive Care Needs Survey Partners & Caregivers (SCNS-P&C)
Timepoint [11] 406120 0
Partners will complete at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [12] 406121 0
Economic Evaluation - The study will use cost-effective analysis and/or cost-benefit analysis depending on the suitability of the outcomes for analysis. The study will evaluate the impact of the intervention on pre-to-post variation in cost due to change in hospitalisation, onwards referrals for supportive care, hospital admissions, outpatient appointments and out-of-hours care for both the intervention versus control (standard care) arms. This will help to estimate the cost savings to the health system and any saving in Out of Pocket Expenditure to the patients.
Timepoint [12] 406121 0
These will be completed at the time of recruitment prior to randomisation, and at 2, 4, 6 months post randomisation.
Secondary outcome [13] 406122 0
Qualitative interviews (patients):

Semi-structured interviews with 12 patients and family/caregiver (6 participants and their family/caregivers from each arm) will be conducted to explore their experience of person-centred supportive care delivery. All interviews will be recorded and transcribed verbatim.
Timepoint [13] 406122 0
All interviews will be conducted at the end of the study.
Secondary outcome [14] 406123 0
Qualitative interviews (healthcare professionals):

12 interviews will be conducted with healthcare professionals to explore the barriers and facilitators to delivering holistic multimodal supportive care. All interviews will be recorded and transcribed verbatim.
Timepoint [14] 406123 0
All interviews will be conducted at the end of the study.

Eligibility
Key inclusion criteria
Patients (and family/caregiver) aged 18 years and over being treated for high-grade gliomas (III/IV), Karnofsky Performance Score (KPS) greater than 50, self-assessed written and verbal English proficiency, able to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Estimated prognosis of fewer than 3 months, KPS <60 or those unable to
follow verbal instructions.

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 by opaque envelope after randomisation by someone outside of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software will be used (sequence generator pro or similar)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Study Population:

Thirty patients including family and/or caregivers will be recruited into this pilot study. Pilot RCT’s do not have the same objectives as a full-scale trial and utilising a formal power calculation for sample determination is not required in this context. For full-scale trials designed with 90% power and 5% level of significance, a sample size of 15 per arm (total n=30) is recommended for pilot RCTs.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The interviews will be analysed using framework analysis and coded by two researchers
to reach overall agreement.

This study will be reported according to CONSORT guidelines. Intention to treat
principles and imputation using last observation carried forward will be applied. Outcome
data will be analysed using mixed-effects, multivariable linear and generalised models.
Estimated effects will be reported with associated 95% confidence intervals and p-values
(compared to 5%).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
Date of last participant enrolment
Anticipated
3/10/2022
Actual
Date of last data collection
Anticipated
10/04/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 35845 0
2600 - Canberra

Funding & Sponsors
Funding source category [1] 310071 0
Government body
Name [1] 310071 0
Canberra Health Services
Country [1] 310071 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari Street
Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 311124 0
None
Name [1] 311124 0
Address [1] 311124 0
Country [1] 311124 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309763 0
Canberra Health Services Ethics Committee
Ethics committee address [1] 309763 0
University Drive,
Bruce ACT 2617
Ethics committee country [1] 309763 0
Australia
Date submitted for ethics approval [1] 309763 0
11/11/2021
Approval date [1] 309763 0
Ethics approval number [1] 309763 0

Summary
Brief summary
This study aims to prospectively assess the impact of multidisciplinary multimodal supportive care intervention on cancer selected outcomes in people diagnosed with high grade glioma (HGG) brain cancer and their family and/or caregiver.

Who is it for?
Adults (18+ years) diagnosed with high-grade (III-IV) gliomas, and if applicable their family and/or caregiver.

Study details:
30 participants will be randomly allocated into one of two groups. One group (n=15) will receive standard care currently available at their clinical site (oral/written information and the contact details of the specialist nurse for additional support, if required). The other group (n=15) will undergo (needs-based) multimodal supportive care, which involves informational materials, holistic needs assessment, self-management care plan and a tailored exercise programme.

It is anticipated the results of this study will improve health outcomes for cancer patients in Canberra by driving changes in local health procedures and policy to ensure better integrated multimodal supportive care based on routine, holistic needs assessments. This project may also have implications that inform care models both domestically and internationally.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115306 0
Prof Catherine Paterson
Address 115306 0
University of Canberra,
11 Kirinari Street
Bruce, ACT, 2617
Country 115306 0
Australia
Phone 115306 0
+61 416860535
Fax 115306 0
Email 115306 0
catherine.paterson@canberra.edu.au
Contact person for public queries
Name 115307 0
Prof Catherine Paterson
Address 115307 0
University of Canberra,
11 Kirinari Street
Bruce, ACT, 2617
Country 115307 0
Australia
Phone 115307 0
+61 41686535
Fax 115307 0
Email 115307 0
catherine.paterson@canberra.edu.au
Contact person for scientific queries
Name 115308 0
Prof Catherine Paterson
Address 115308 0
University of Canberra,
11 Kirinari Street
Bruce, ACT, 2617
Country 115308 0
Australia
Phone 115308 0
+61 416860535
Fax 115308 0
Email 115308 0
catherine.paterson@canberra.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


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.