Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001180606p
Ethics application status
Submitted, not yet approved
Date submitted
13/09/2023
Date registered
15/11/2023
Date last updated
21/06/2024
Date data sharing statement initially provided
15/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeting wellBeing in AdoLescent and young Adult treated for CaNCEr (BALANCE)
Scientific title
WellBeing in AdoLescent and young Adult treated for CaNCEr (BALANCE): Assessing the Impact of a digital lifestyle program on Quality of Life in Young People Treated for Cancer
Secondary ID [1] 310477 0
BALANCE
Universal Trial Number (UTN)
Trial acronym
BALANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer recovery 331415 0
Condition category
Condition code
Alternative and Complementary Medicine 328163 328163 0 0
Other alternative and complementary medicine
Cancer 328372 328372 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BALANCE intervention was developed with adolescents and adults (AYAs) experienced with cancer and clinicians specialising in youth and young adult in cancer care.

The intervention consists of different components:

Educational modules
The BALANCE intervention consists of a selection of online lifestyle modules and three individual one-hour coaching sessions with the interventionists (psychologists, social workers or nurses experienced in cancer care and specifically trained in the intervention) delivered over an 8-week period. Modules will be delivered within 3 domains:
Body, Mind, and Connections.

The Body modules covers sub-modules on movement, nourishment, rest, reproduction, pain and health screening; the Mind module encompasses emotional wellbeing; and the Connections module aims to support social wellbeing, with a focus of friends, family, intimacy, and the wider world such as negotiating schoolwork, university or employment.

The educational information will be delivered in various forms: text, short videos, podcasts, and links to reputable websites. The length of each topic varies between 30 and 90 minutes to complete. Participants will be able to pause and return to the module or skip topics that may not interest them.

AYAs have varying needs; hence the intervention ‘prescribed’ by the clinician is individually tailored to each participant during their first intervention consultation. However, the modules covering movement, nourishment and emotional distress are mandatory (and consistently measured at each time point), whereas the remaining modules are non-compulsory. Participants will have the flexibility to complete intervention modules based on their interests and needs, completing them at their own pace and preferred time. Within the coaching sessions, interventionists will guide participants to additional modules mutually considered to be suitable for their needs, creating personalised support. For participants with specific concerns or quantified distress, a mechanism has been developed for evaluation and referral to specialists at Canteen or within the Youth Cancer Services.

Interactive components
There are also interactive components within the BALANCE program, which comprise:
1. Motivational messages for eight weeks via an interactive eBook, animations and video podcasts accessible via the project’s secure web platform.
2. Online diary and journaling tools contextualised to the program, which are confidential to the participant and not able to be accessed by project staff.
3. A private and fully moderated online community (Canteen Connect) for participants to foster peer support and encouragement to achieve their individual goals.
4. A link to the project’s online data collection platform to enable participants to fill out study questionnaires at the specified time points.

Virtual consultations
All participants will undertake three individual one-hour consultations with Canteen staff (cancer nurses, psychologists and social workers) trained in the intervention over the 8-week intervention period. All participants will have an introductory session with a research assistant to ascertain their baseline health and wellbeing needs.

Coaching sessions will occur at Weeks 2, 5 and 8 via Zoom, enabling remote access to expert advice and support in the participant’s choice of location. In keeping with privacy guidelines, virtual consultations will occur in a private environment and will not be recorded. The structure of the three coaching sessions will include:
1. Rapport building, assessment of personal risk factors, exploration of personal aims, collaborative goal setting for behavioural changes relevant to personal risk factors and participant aims, and discussions on movement, nourishment, and emotional well-being.
2. Checking in with the participant's progress in the program, reviewing and addressing any issues, discussing relevant learning modules, exploring the integration of self-care into their weekly routine, and addressing strategies for managing setbacks.
3. Reflecting on the participant's feelings about the program, reviewing and addressing any issues, revisiting goals and making necessary adjustments, discussing ways to stay motivated, and emphasizing the importance of establishing lifelong healthy habits.
Adherence will be measured in several ways: website analytics to monitor completion of online modules and attendance at coaching sessions.
Intervention code [1] 326968 0
Lifestyle
Comparator / control treatment
No control group - this is a one-arm interrupted time series study, with measures undertaken at 12 timepoints.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336036 0
Quality of life assessed by Assessment of Quality of Life - 6D scale (AQoL-6D) for adolescents and young adults
Timepoint [1] 336036 0
Pre-intervention (8 weeks): Week -8, -6, -4, -2
During intervention (8 weeks): Week 2, 4, 6, 8
Post-intervention (12 weeks): Week 10, 12, 14, 20
Primary outcome [2] 336213 0
Quality of life assessed by Visual Analogue Scale – Quality of Life (VAS)
Timepoint [2] 336213 0
Pre-intervention (8 weeks): Week -8, -6, -4, -2
During intervention (8 weeks): Week 2, 4, 6, 8
Post-intervention (12 weeks): Week 10, 12, 14, 20
Secondary outcome [1] 426535 0
Self-efficacy assessed by Patient Activation Survey (PAS)
Timepoint [1] 426535 0
Pre-intervention (8 weeks): Week -8, -6, -4, -2
During intervention (8 weeks): Week 2, 4, 6, 8
Post-intervention (12 weeks): Week 10, 12, 14, 20
Secondary outcome [2] 426536 0
Physical movement by FitBit data
Timepoint [2] 426536 0
This will be collected continuously from week -8 to week 20.
Secondary outcome [3] 426537 0
Psychological distress by the Emotion Thermometer (ET)
Timepoint [3] 426537 0
Pre-intervention (8 weeks): Week -8, -6, -4, -2
During intervention (8 weeks): Week 2, 4, 6, 8
Post-intervention (12 weeks): Week 10, 12, 14, 20
Secondary outcome [4] 426538 0
Body image by the Body Image Scale (BIS)
Timepoint [4] 426538 0
Pre-intervention: Week -8
During intervention: Week 8
Post-intervention: Week 20
Secondary outcome [5] 426539 0
Sleep health by the Insomnia Severity Index (ISI)
Timepoint [5] 426539 0
Pre-intervention: Week -8
During intervention: Week 8
Post-intervention: Week 20
Secondary outcome [6] 426540 0
Dietary habits by the Food Variety Checklist (FVC)
Timepoint [6] 426540 0
Pre-intervention: Week -8
During intervention: Week 8
Post-intervention: Week 20
Secondary outcome [7] 426541 0
Patterns of alcohol and other substance use will be assessed as a composite secondary outcome, measured by by relevant items in the National Drug and Strategy Household Survey.
Timepoint [7] 426541 0
Pre-intervention: Week -8
During intervention: Week 8
Post-intervention: Week 20
Secondary outcome [8] 427356 0
Sleep duration by FitBit data
Timepoint [8] 427356 0
This will be collected continuously from week -8 to week 20.

Eligibility
Key inclusion criteria
Inclusion criteria
• Confirmed diagnosis of any cancer;
• Aged between 15-25 years at time of recruitment;
• Completed intensive cancer treatment including surgery, chemotherapy and radiotherapy (individuals may participate while still on maintenance therapy for cancer e.g., oral chemotherapy, 3-monthly vincristine and intrathecal methotrexate permitted);
• Legally able to consent (aged >17 years) or assent (aged <18 years) with parental/guardian parental consent obtained;
• Able to access a computer, tablet or smart phone, and internet in any form.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
• Have any clinical contraindication that precludes safe completion of the program in the judgement of the project team;
• Receiving intensive cancer treatments while enrolled.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
209
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 314680 0
Government body
Name [1] 314680 0
National Health and Medical Research Council
Country [1] 314680 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Level 3, Chamberlain Building (35), Campbell Road, St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 316760 0
None
Name [1] 316760 0
Address [1] 316760 0
Country [1] 316760 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313697 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 313697 0
Ethics committee country [1] 313697 0
Australia
Date submitted for ethics approval [1] 313697 0
28/08/2023
Approval date [1] 313697 0
Ethics approval number [1] 313697 0

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

Contacts
Principal investigator
Name 129054 0
Prof Alexandra McCarthy
Address 129054 0
G40 Griffith Health Centre, Griffith University, Gold Coast Campus, Southport QLD 4215
Country 129054 0
Australia
Phone 129054 0
+61428566283
Fax 129054 0
Email 129054 0
[email protected]
Contact person for public queries
Name 129055 0
Vivian Chiu
Address 129055 0
Level 3, Chamberlain Building (35), Campbell Road, The University of Queensland St Lucia QLD 4072
Country 129055 0
Australia
Phone 129055 0
+61451179629
Fax 129055 0
Email 129055 0
[email protected]
Contact person for scientific queries
Name 129056 0
Alexandra McCarthy
Address 129056 0
G40 Griffith Health Centre, Griffith University, Gold Coast Campus, Southport QLD 4215
Country 129056 0
Australia
Phone 129056 0
+61428566283
Fax 129056 0
Email 129056 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
20289Study protocol    Not yet available



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.