Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000382471p
Ethics application status
Submitted, not yet approved
Date submitted
14/04/2025
Date registered
30/04/2025
Date last updated
30/04/2025
Date data sharing statement initially provided
30/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
REST: Randomised trial of an intervention targeting self-Efficacy to self-manage cancer-related fatigue in people with a primary brain Tumour
Scientific title
REST: Randomised trial of an intervention targeting self-Efficacy to self-manage cancer-related fatigue in people with a primary brain Tumour
Secondary ID [1] 314189 0
None
Universal Trial Number (UTN)
Trial acronym
REST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Primary Brain Tumour 337062 0
Cancer-related fatigue 337063 0
Condition category
Condition code
Cancer 333504 333504 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An online intervention targeting self-efficacy to self-manage cancer-related fatigue (CRF). The online intervention consists of six sessions that will be completed across a 12 week period. Each session takes approximately 30 minutes to complete. The content of each session is summarised below:

Session 1 (About Fatigue) provides education about CRF, including how it is commonly experienced by people with a primary brain tumour and what the possible causes and impacts are. It includes video animations of patient narratives about their experiences of CRF. Participants are asked to identify areas of their life affected by fatigue that they would like to focus on throughout the intervention. An optional quiz on CRF is provided for those who would like to assess their own knowledge.

Session 2 (Making Plans) introduces the concept of self-monitoring and setting plans to address fatigue using SMART goals (i.e. specific, measurable, attainable, relevant, and time bound). Possible barriers to following plans are discussed and video animations of patient narratives describing the usefulness of setting plans to manage fatigue are included. External links to useful resources are also provided.

Session 3 (Home and Lifestyle) describes how CRF may impact on aspects of everyday life including home life, and how setting effective plans can help to manage this interference. Impacts of CRF on exercise, housework, laundry, childcare, diet, grocery shopping, sleep and meal preparation are discussed, along with strategies for managing these impacts. External links to useful information and resources are provided.

Session 4 (Work) focuses on how CRF can impact on work and provides strategies for managing these impacts including by setting effective plans. External links are provided to useful information and resources.

Session 5 (Thoughts & Feelings) focuses on how thoughts and feelings can impact CRF and how this can be managed using CBT principles, as well as by setting effective management plans. It discusses self-esteem, uncertainty, stress, worry and anxiety, and negative thoughts and feelings generally, and provides strategies for helping to manage them. External links to additional information and resources are provided.

Session 6 (Talking to Others) describes the difficulties of talking to others about CRF and introduces strategies to help manage this, including through setting effective plans. It includes strategies for talking to employers, friends and family, health professionals, and choosing not to talk. External links to useful resources are provided.


Activities are available throughout each session. These include an online fatigue diary participants can use to monitor their fatigue from day-to-day, in addition to single-item assessments of fatigue at the beginning of each session. Stories (video animations) from people with primary brain tumour are included throughout to provide examples of how people with a brain tumour are affected by CRF and strategies they have used to help them manage. Automated tailored feedback based on goal-related progress and change in fatigue levels from the previous session are included throughout and links are provided to additional information and useful resources relevant to each session. Participants can pause completion and return to a particular session either later that same day or on a different day if necessary. During the trial, patients will receive automated emails encouraging them to complete their session or begin the next session if they have not done so within 14 days. Similar emails will be sent to prompt completion of outcome measures. If participants choose not to complete a particular session they will be asked to provide a reason.

Adherence to the intervention will be captured using website analytics.

Intervention code [1] 330797 0
Rehabilitation
Comparator / control treatment
An online relaxation intervention consisting of six sessions that will be completed across a 12 week period. Each session takes approximately 30 minutes to complete. Each online session is self-guided and will be undertaken independently by the participants. Each session is based on a manualized relaxation training program for cancer patients, The online sessions will deliver training in progressive and passive muscle relaxation, meditative relaxation, visualisation and “quick relaxation” techniques, with regular homework exercises between sessions. The training is delivered via text-based materials and audio-recordings of relaxation training exercises.


Adherence to the intervention will be captured using website analytics.


Control group
Active

Outcomes
Primary outcome [1] 341099 0
Perceived Self-Efficacy for Fatigue Self-Management
Timepoint [1] 341099 0
Baseline, 12 weeks (immediately post- completion of the online intervention program), and 24 weeks post-baseline.
Secondary outcome [1] 446225 0
Cancer-Related Fatigue
Timepoint [1] 446225 0
Baseline, 12 weeks (immediately post- completion of the online intervention program), and 24 weeks post-baseline.
Secondary outcome [2] 446226 0
Health-related quality of life (HRQL)
Timepoint [2] 446226 0
Baseline, 12 weeks (immediately post- completion of the online intervention program), and 24 weeks post-baseline.
Secondary outcome [3] 446227 0
Depressive symptoms
Timepoint [3] 446227 0
Baseline, 12 weeks (immediately post- completion of the online intervention program), and 24 weeks post-baseline.
Secondary outcome [4] 446228 0
Acceptability
Timepoint [4] 446228 0
At 12 weeks (immediately post- completion of the online intervention program).

Eligibility
Key inclusion criteria
Eligible patients:
• Will have a histologically confirmed diagnosis of a malignant primary brain tumour
• Will have a life expectancy of at least 24 weeks
• Will have a score in the clinical range (4 or more) on the unidimensional 11-point numeric single item rating scale for fatigue included in the Edmonton Symptom Assessment Scale (ESAS).
• Will be 18 years or older
• Are able to provide informed consent in the opinion of a member of their healthcare team
• Will be English-speaking
• Will have or are willing to create an email account and have access to the internet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are:
• Less than 6-8 weeks post-surgery or radiation treatment
• ECOG Performance status of 3 or more
• Diagnosis of a benign primary brain tumour
• Unable to engage in the intervention and/or study assessments determined by a member of their clinical team

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)
Randomisation will be generated by a statistician blinded to the identity of participants, using computer-generated random numbers. A research assistant will notify participants of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be generated by a statistician using permuted blocks of size 4 and 6 in REDCap. Participants will be randomly assigned to receive either the RESTORE-BT or relaxation intervention in a 1:1 ratio. Randomisation will be stratified by (i) low vs high grade tumour; (ii) active treatment (i.e. Chemoradiation or clinical trial participation) versus not; (iii) h moderate (i.e. score 4-6 on ESAS) versus severe (i.e. score 7-10 on ESAS) fatigue; (iv) fully active or slightly restricted (0-1 ECOG score) versus limited ability to perform daily activities (ECOG 2); and (v) less than versus more than two years post diagnosis; these characteristics will be participant-reported.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
The primary outcome is Perceived Self Efficacy for Fatigue Self-Management, a 6-item scale with the total score ranging from 0-10.

We plan to recruit approximately 200 participants. This number is based primarily on practical considerations including the estimated number of eligible participants and the time frame for the study. A study of 200 participants has 80% power at 5% two-sided significance level to detect a difference in mean self-efficacy scores between groups, assuming a true difference in means of 0.45 standard deviations and loss to follow-up of approximately 20%. In the Foster study (Foster et al., 2015) the between-participant standard deviation of self-efficacy scores was approximately 2.2, so a difference of 0.45 SDs corresponds to a difference in means of approximately one unit on the outcome scale of 0-10.

The primary analysis will use a linear model to compare scores at T1 (12 weeks after baseline) between randomised groups with adjustment for baseline score. If the within-participant correlation between baseline and T1 scores is greater than zero, the power will increase or a smaller true difference can be assumed. For example, with correlation of 0.5 between baseline and T1 scores in the same participant a true difference of 0.39 SDs can be assumed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2027
Actual
Date of last data collection
Anticipated
6/03/2028
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318707 0
Government body
Name [1] 318707 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF) Brain Cancer Mission
Country [1] 318707 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321136 0
None
Name [1] 321136 0
Address [1] 321136 0
Country [1] 321136 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317313 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317313 0
Ethics committee country [1] 317313 0
Australia
Date submitted for ethics approval [1] 317313 0
16/04/2025
Approval date [1] 317313 0
Ethics approval number [1] 317313 0

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

Contacts
Principal investigator
Name 140666 0
Dr Rachel Campbell
Address 140666 0
School of Psychology, Brennan-Maccallum Building (A18), The University of Sydney, NSW, 2006
Country 140666 0
Australia
Phone 140666 0
+61 2 8627 7631
Fax 140666 0
Email 140666 0
[email protected]
Contact person for public queries
Name 140667 0
Dr Rachel Campbell
Address 140667 0
School of Psychology, Brennan-Maccallum Building (A18), The University of Sydney, NSW, 2006
Country 140667 0
Australia
Phone 140667 0
+61 2 8627 7631
Fax 140667 0
Email 140667 0
[email protected]
Contact person for scientific queries
Name 140668 0
Rachel Campbell
Address 140668 0
School of Psychology, Brennan-Maccallum Building (A18), The University of Sydney, NSW, 2006
Country 140668 0
Australia
Phone 140668 0
+61 2 8627 7631
Fax 140668 0
Email 140668 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.