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Trial registered on ANZCTR


Registration number
ACTRN12618001737224
Ethics application status
Approved
Date submitted
18/10/2018
Date registered
22/10/2018
Date last updated
2/11/2018
Date data sharing statement initially provided
31/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a telehealth intervention for delivering psychological support to people with brain tumour and their families
Scientific title
A randomised controlled trial comparing the clinical efficacy and cost-effectiveness of a telehealth psychological support intervention with standard care for people with brain tumours and their families
Secondary ID [1] 296362 0
APP1152217
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary brain tumour 310092 0
Depression 310122 0
Anxiety 310123 0
Condition category
Condition code
Cancer 308837 308837 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The telehealth Making Sense of Brain Tumour (Tele-MAST) program is adapted from the face-to-face Making Sense of Brain Tumor program. This program involves 10 x 1 hour weekly individual therapy sessions delivered by a psychologist, with the focus of support guided by individuals’ goals and family involvement (i.e., individual, couple, and family support sessions). Common goals relate to understanding the effects of brain tumour (psychoeducation), managing emotional distress (psychoeducation & psychotherapy), managing cognitive and behavioural changes (cognitive rehabilitation, family education), improving relationship functioning (couple & family-based support), and addressing fears/concerns regarding end-of-life issues and legacy making. Participants will use their own device (PC, laptop, Ipad) from home to receive therapy sessions via Zoom video-conferencing. Family members' involvement in therapy will vary across programs, depending on the family member's availability and the program goals. Therapy sessions will be recorded using Zoom Cloud Recording (M4A files, audio only) with 15% reviewed (random selection) at the end of the project to examine adherence to the therapy protocol.
Intervention code [1] 312695 0
Treatment: Other
Comparator / control treatment
As a pragmatic trial, the Tele-MAST program is being compared to the current standard of care for people with cancer including brain tumour. Current services available for cancer patients in the Queensland context are based on a stepped care model that involves distress screening and referral to nurse counsellor or psychology services. Individuals presenting with moderate to severe distress typically receive up to 5 x 1 hour sessions of psychological support from a psychologist.

Participants in the standard care condition will receive routine psychological support from the Cancer Council Queensland in accordance with the stepped model of care. This will entail up to 5 sessions (1 hour) of psychological support delivered via telephone, Skype or face-to-face, depending upon participants' circumstances. The number of sessions, general focus (e.g., stress management), duration and mode of delivery of standard care sessions will be systematically recorded. This group will also serve as a wait list control condition, as participants will be offered the telehealth intervention after the 6-week post-intervention follow-up.
Control group
Active

Outcomes
Primary outcome [1] 307813 0
Depression

Severity of depression will be measured using the Montgomery-Asberg Depression Rating Scale: a semi-structured clinical interview assessing the presence and severity of depression. The 10 items are clinician-rated on a seven-point Likert scale, ranging from 0 (no or minimal symptoms) to 6 (maximum symptoms), with total scores of 0-60.
Timepoint [1] 307813 0
Measured at baseline, post-intervention (within 1 week of completing program - primary timepoint), 6-weeks post-intervention, 6-months post-intervention
Secondary outcome [1] 353004 0
Quality of life (global and physical, social, emotional, and functional well-being domains),

Functional Assessment of Cancer Therapy-Brain: a 50-item QoL measure assessing physical, social, emotional, and functional well-being and neurological symptoms.
Timepoint [1] 353004 0
Measured at baseline, post-intervention (within 1 week of program completion), 6-weeks post-intervention, 6-months post-intervention

Secondary outcome [2] 353005 0
Anxiety

Generalized Anxiety Disorder 7-item: a 7-item measure of the cognitive and affective components of anxiety that omits items on somatic/musculoskeletal effects that can directly arise from brain tumour or its treatment
Timepoint [2] 353005 0
Measured at baseline, post-intervention (within 1 week of program completion), 6-weeks post-intervention, 6-months post-intervention
Secondary outcome [3] 353008 0
Low mood

Depression scale from the Depression, Anxiety and Stress Scales-21: a 7 item self-report measure assessing affective symptoms of low mood that omits items on somatic/physical and neuro-vegetative symptoms that can directly arise from brain tumour or its treatment;
Timepoint [3] 353008 0
Measured at baseline, post-intervention (within 1 week of program completion), 6-weeks post-intervention, 6-months post-intervention
Secondary outcome [4] 353012 0
Existential well-being

The Existential well-being subscale of the McGill Quality of Life Questionnaire assesses people’s sense of control, purpose and meaning in their existence and self-worth.
Timepoint [4] 353012 0
Measured at baseline, post-intervention (within 1 week of program completion), 6-weeks post-intervention, 6-months post-intervention
Secondary outcome [5] 353018 0
Quality Adjusted Life Years

The EuroQoL-5D (EQ-5D-5L) will measure preference-based QoL to calculate quality-adjusted life years (QALYs) and incremental cost per QALY gained for the Tele-MAST intervention relative to standard CCQ care. The EQ-5D items include mobility, self-care, usual activities, pain/discomfort & anxiety/depression. EQ-5D scores (0 = worse possible health to 1 = perfect health) are used to weight survival time to generate QALYs.
Timepoint [5] 353018 0
Measured at baseline, post-intervention (within 1 week of program completion), 6-weeks post-intervention, 6-months post-intervention
Secondary outcome [6] 353020 0
Family members' psychological well-being

Depression Anxiety Stress Scales 21
Timepoint [6] 353020 0
Measured at baseline, post-intervention (within 1 week of program completion), 6-weeks post-intervention, 6-months post-intervention
Secondary outcome [7] 353024 0
Family member's quality of life

WHOQOL-BREF (26 items)
Timepoint [7] 353024 0
Measured at baseline, post-intervention (within 1 week of program completion), 6-weeks post-intervention, 6-months post-intervention
Secondary outcome [8] 353110 0
Incremental cost per QALY gained

The EuroQoL-5D (EQ-5D-5L) will measure preference-based QoL to calculate quality-adjusted life years (QALYs) and incremental cost per QALY gained for the Tele-MAST intervention relative to standard CCQ care. The EQ-5D items include mobility, self-care, usual activities, pain/discomfort & anxiety/depression. EQ-5D scores (0 = worse possible health to 1 = perfect health) are used to weight survival time to generate QALYs. Incremental cost per effect ratios will be generated from the EQ-5D data using an Australian algorithm and norms to represent the additional cost and health benefits of the Tele-MAST program over and above that of usual care. The difference in mean costs divided by the difference in mean QALYs/% improvers generates the incremental cost per QALY/% improver ratios between two arms. These analyses will be conducted by a senior health economist.
Timepoint [8] 353110 0
Measured at baseline, post-intervention (within 1 week of program completion), 6-weeks post-intervention, 6-months post-intervention
Secondary outcome [9] 353446 0
Distress on the Distress Thermometer with a threshold of 4 or higher out of 10 indicating the need for psychosocial support.
Timepoint [9] 353446 0
Measured at baseline, post-intervention (within 1 week of program completion), 6-weeks post-intervention, 6-months post-intervention
Secondary outcome [10] 353447 0
Patient costs: Out-of-pocket expenses ($ over the past 3 months) assessed using a study-specific questionnaire that requests information on costs specific to receiving psychological support through the telehealth platform or CCQ standard care
Timepoint [10] 353447 0
Measured only at the 6-week post-intervention follow-up
Secondary outcome [11] 353448 0
Financial impact of illness, as measure using the Comprehensive Score for Financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy
Timepoint [11] 353448 0
Measured only at the 6-week post-intervention follow-up

Eligibility
Key inclusion criteria
Participants will be eligible if they meet the following criteria:
1) diagnosis of a benign or malignant primary brain tumour at any stage of disease or time post-onset;
2) evidence of psychological distress on screening (i.e., Distress Thermometer [DT] score 4+/10);
3) adequate cognitive capacity and receptive and expressive English language skills to participate in therapy; and
4) reliable access to the Internet and a computer, which individuals can operate independently or with a family member’s support.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Metastatic brain tumour, severe sensory, perceptual, cognitive and/or language impairment that affect participants' capacity to understand and complete assessments and engage in therapy. Insufficient receptive and expressive English language skills.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random allocation will occur independent of the project staff with allocation concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pre-determined computer generated sequence. Randomisation will be stratified according to baseline distress (DT scores of moderate [4-7/10] vs severe [8+/10]) and family involvement in therapy (yes vs. no).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
A standard care condition based on Cancer Council Queensland's cancer counselling service is needed to examine the effectiveness of the Tele-MAST intervention relative to existing cancer support services. Participants in the standard CCQ condition will be offered the Tele-MAST intervention after the 6-week follow-up (T3). A shortened waitlist period of 4 months (T1-T3) will be adopted rather than 10 months (T1 to 6-month follow-up) as this design best balances the potential negative effects of withholding brain tumour specific therapy with the need to maintain validity of the results.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Our previous RCT of the MAST intervention (Ownsworth et al., 2015) found moderate to large effect sizes for between-group differences in depression, existential well-being, and global QoL, indicating better mental health and QoL for MAST participants relative to wait list controls. A moderate effect size was used in the power calculation because this difference is considered clinically meaningful and is consistent with previous telehealth interventions. A power analysis was conducted using G*Power with an estimated moderate effect size (partial eta squared =.08), alpha level of .05, and power >0.80. A sample size of n = 123 (62 per group) would be required to detect a moderate sized difference in severity of depression between the Tele-MAST and standard care groups at the post-intervention assessment (primary endpoint) controlling for baseline depression.

A mixed model approach to repeated measures with group allocation as the between-subjects factor, time (post-intervention, 6-weeks follow-up) as the repeated factor and baseline functioning (T1) as the covariate will be used to evaluate whether the Tele-MAST intervention is more effective than standard care for the primary and secondary outcome measures at post-intervention (T2), and whether these effects are sustained at 6-weeks follow-up (T3). Any demographic or clinical variables that are significantly associated with the outcome variables will be included as covariates. The same approach will be used to examine the impact of the Tele-MAST intervention on family caregivers’ mood and QoL. Longer-term outcomes of the Tele-MAST intervention will be examined using the six month follow-up data (T4), relative to baseline functioning (T1).

Recruitment
Recruitment status
Recruiting
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
Recruitment hospital [1] 12204 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 24378 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 24379 0
4006 - Fortitude Valley

Funding & Sponsors
Funding source category [1] 300964 0
Government body
Name [1] 300964 0
National Health & Medical Research Council
Address [1] 300964 0
National Health & Medical Research Council
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 300964 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
School of Applied Psychology, Griffith University
Mt Gravatt Campus,
176 Messines Ridge Road, 4122
Queensland
Country
Australia
Secondary sponsor category [1] 300539 0
None
Name [1] 300539 0
Address [1] 300539 0
Country [1] 300539 0
Other collaborator category [1] 280397 0
Charities/Societies/Foundations
Name [1] 280397 0
Cancer Council Queensland
Address [1] 280397 0
553 Gregory Terrace, Fortitude Valley QLD 4006
Country [1] 280397 0
Australia
Other collaborator category [2] 280398 0
Hospital
Name [2] 280398 0
Princess Alexandra Hospital
Address [2] 280398 0
199 Ipswich Rd, Woolloongabba QLD 4102
Country [2] 280398 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301728 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 301728 0
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Ethics committee country [1] 301728 0
Australia
Date submitted for ethics approval [1] 301728 0
23/07/2018
Approval date [1] 301728 0
04/09/2018
Ethics approval number [1] 301728 0
HREC/2018/QMS/43843
Ethics committee name [2] 301734 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 301734 0
Office for Research
Kessels Road
Griffith University, Nathan, 4111
Queensland
Ethics committee country [2] 301734 0
Australia
Date submitted for ethics approval [2] 301734 0
10/09/2018
Approval date [2] 301734 0
28/09/2018
Ethics approval number [2] 301734 0
GU Ref No: 2018/808.

Summary
Brief summary
The purpose of this study is to determine if 10 sessions of psychological support, delivered online, is effective in improving the mental health of those with brain tumours and their families.

Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with a benign or malignant brain tumour.

Study details
Participants in this study will undergo one of the two following treatments:
Treatment 1 – participants will receive up to five 1-hour sessions of psychological support from a psychologist. These may be done over the phone, online or face-to-face. These participants will have the option of completing treatment 2 after 4 months.
Treatment 2 – participants will receive ten 1-hour sessions from a psychologist either individually or with family involvement. These will be done online by using video-conferencing technology from their own home.
The treatment the participant will complete will be randomly decided.

Participants will be asked to complete measures of mental health and quality of life before and after the treatment, as well as 6-weeks and 6-months after the treatment.

It is hoped that this research will help determine if online psychological interventions are able to improve mental health and quality of life for people with brain tumours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87910 0
Prof Tamara Ownsworth
Address 87910 0
School of Applied Psychology
Griffith University, Mt Gravatt campus
Mt Gravatt, 4122
Queensland
Country 87910 0
Australia
Phone 87910 0
+61 07 3735 3307
Fax 87910 0
Email 87910 0
t.ownsworth@griffith.edu.au
Contact person for public queries
Name 87911 0
Miss Stephanie Jones
Address 87911 0
School of Applied Psychology
Griffith University, Mt Gravatt campus
Mt Gravatt, 4122
Queensland
Country 87911 0
Australia
Phone 87911 0
+61 07 3735 3324
Fax 87911 0
Email 87911 0
stephanie.jones@griffith.edu.au
Contact person for scientific queries
Name 87912 0
Prof Tamara Ownsworth
Address 87912 0
School of Applied Psychology
Griffith University, Mt Gravatt campus
Mt Gravatt, 4122
Queensland
Country 87912 0
Australia
Phone 87912 0
+61477717068
Fax 87912 0
Email 87912 0
t.ownsworth@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
The organisations providing ethical clearance do not permit individual participant data sharing even in de-identified form
What supporting documents are/will be available?
Study protocol
Summary results
Not applicable