Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000849392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
19/05/2026
Date registered
Help: Date registered
13/07/2026
Date last updated
Help: Date last updated
13/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/07/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
The MyWell Study: A randomised trial of a co-designed, group-based mental wellbeing intervention for people living with myeloma.
Scientific title
The MyWELL Study: A randomised hybrid implementation-effectiveness type 1 trial of a co-designed, group-based mental wellbeing intervention for people living with myeloma.
Additional trial identifiers [1] 317332 0
Nil known
Universal Trial Number (UTN)
U1111-1341-0302
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
mental wellbeing 341985 0
depression 341986 0
anxiety 341987 0
myeloma 342487 0
Condition category
Condition code
Cancer 338064 338064 0 0
Myeloma
Mental Health 338614 338614 0 0
Anxiety
Mental Health 338615 338615 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
MyWell Plan
The MyWell Plan is a personalised wellbeing plan that participants develop and refine throughout the program. It is an individualised implementation plan for evidence-based psychological skills and wellbeing habits. Participants identify meaningful and achievable actions that support their mental health and wellbeing while living with myeloma, and progressively update these actions as they learn new skills and insights across the seven sessions.

A full description of the program sessions is detailed below:

1. Introduction to Living Well with Myeloma (Foundations of mental health and habits). Key components: Group norms, meaningful pictures, mental health overview, myeloma–mental health links, living well case studies, identifying existing routines, early habit formation.
2. Noticing Our Thoughts (Thinking patterns & mindfulness). Key components: Thinking traps, negativity bias, consequences of unhelpful thinking, mindfulness skills, autopilot case study, mindfulness practice videos, embedding a mindfulness habit.
3. Gaining a Different Perspective (Self-awareness & self-compassion). Key components: Be Well Tracker assessment, choosing a wellbeing domain, self-compassion theory, compassionate friend exercise, habit refinement and addition.
4. Using Resources to Manage Ups & Downs (Personal resources & character strengths). Key components: Hardship and wellbeing, meaningful pictures, resilience, identifying personal resources, character strengths, converting strengths into habits, adding another wellbeing habit.
5. Improving the Way We Manage with Myeloma (Part 1) (Emotional processing & psychological flexibility). Key components: Grief and loss, biopsychosocial influences, acceptance, thought defusion, psychological flexibility, connection-focused activities, Be Well Plan updates.
6. Improving the Way We Manage with Myeloma (Part 2) (Coping strategies & support systems). Key components: Distress and coping styles, grounding and problem-focused coping, barriers to coping, mapping social and professional supports, practising communication, updating wellbeing plans.
7. Review & Preparing for the Future (Integration, progress & sustainability). Key components: Program reflection, progress and optimism, interpreting tracker results, defining what living well now looks like, refining final habits, routines for sustained change, group encouragement, wrap-up and survey.


Facilitator training
A total of seven Myeloma Nurses will be accredited as facilitators of the MyWell program. Accreditation consists of a 2.5-day face-to-face training program delivered by the research team in partnership with Be Well Co prior to commencement of participant enrolment and intervention delivery. Training covers the theoretical foundations of the Be Well Plan methodology, program content, group facilitation skills, use of the facilitator manual and participant workbook, and procedures for safe and consistent intervention delivery. Nurses will deliver the program in pairs, with an additional trained facilitator available to cover absences.

Duration and frequency
The intervention comprises seven sessions delivered over seven consecutive weeks. Each session is approximately two hours in duration and is delivered via Zoom. Participants receive a printed workbook by post to support engagement with session activities and development of their MyWell Plan between sessions.

Monitoring adherence and intervention fidelity
Several strategies will be used to support and monitor intervention adherence and fidelity:

All facilitators will receive a detailed session-by-session manual and a standardised checklist specifying required content, key activities, and therapeutic processes for each session.
Facilitators will complete the checklist following each session, documenting coverage of prescribed content and rating participant engagement with each topic.
Facilitators may access additional booster or refresher supervision and training sessions as required, including a scheduled mid-program refresher opportunity, to support ongoing adherence to the intervention protocol.
Participant adherence will be monitored through attendance records and automated weekly surveys delivered via email or SMS (according to participant preference). These surveys will assess session attendance, self-reported engagement during attended sessions, and completion of recommended between-session activities and home practice.
Intervention code [1] 334121 0
Prevention
Intervention code [2] 334122 0
Behaviour
Description of the comparator or control
This study will use a waitlist control with enhanced treatment-as-usual (TAU) and Minimal Ethical Control (MEC) components. There is currently no clearly defined, uniformly delivered psychological standard of care for distress in multiple myeloma in Australia. Patients typically manage emotional health through a heterogeneous mix of self-initiated strategies, Myeloma Australia nurse-led telephone support and peer support groups, and primary-care or private psychology referrals.

Waitlist participants will gain access to the intervention 1 month after the intervention group has completed the program.

Considering ethical and methodological limitations of a waitlist control in the absence of a standard Treatment As Usual, participants randomised to the control arm will receive the following structured package, which reflects real-world usual care while meeting contemporary ethical standards for waitlist designs in psycho-oncology: (1)Provision of the Myeloma Australia “Emotional Health and Wellbeing” fact sheet, (2) Information about self-referral pathways to existing Myeloma Australia support groups and the national nurse support hotline, (3) Clear escalation pathways and 24/7 crisis contact details in the event of clinical deterioration.

To mirror the weekly contact schedule of the intervention arm and to reduce attrition, these usual-care resources will be delivered in seven weekly emails (one per week for the duration of the active intervention phase). Each email will contain one section of the fact sheet, a brief wellbeing tip, and a reminder of available support options.

Participants in the control arm remain free to access any additional community or clinical mental health services they would normally use. Randomisation is expected to balance the use of these heterogeneous supports across arms, and data on service use will be collected.
Control group
Active

Outcomes
Primary outcome [1] 345471 0
Anxiety
Timepoint [1] 345471 0
baseline and 1-month post intervention for both intervention and waitlist group
Primary outcome [2] 345472 0
Depression
Timepoint [2] 345472 0
baseline and 1-month post intervention for both intervention and waitlist group
Secondary outcome [1] 461781 0
Mental wellbeing
Timepoint [1] 461781 0
baseline and 1-month post intervention for both intervention and waitlist group
Secondary outcome [2] 461782 0
Wellbeing Empowerment
Timepoint [2] 461782 0
baseline and 1-month post intervention for both intervention and waitlist group
Secondary outcome [3] 461783 0
Quality of Life
Timepoint [3] 461783 0
baseline and 1-month post intervention for both intervention and waitlist group
Secondary outcome [4] 461784 0
Quality of Life
Timepoint [4] 461784 0
baseline and 1-month post intervention for both intervention and waitlist group
Secondary outcome [5] 461785 0
Health Service Usage
Timepoint [5] 461785 0
baseline and 1-month post intervention for both intervention and waitlist group

Eligibility
Key inclusion criteria
There are two participant groups in the current study, program participants and program facilitators. Program participants should meet the following criteria: (1) aged 18+ years and living in Australia, (2) diagnosed with SMM or MM (including newly diagnosed cases), (3) able to communicate in English, (4) access to internet-enabled device (for online participation), and (5) available for the proposed intervention session dates.

Myeloma nurses, who will deliver the My Well Plan, will be included in the study as participants primarily to capture implementation barriers and enablers. They will be recruited on the following criteria: (1) Voluntarily expressed interest in participating as a facilitator to deliver the program within usual paid work hours, (2) Currently employed as a Myeloma Australia nurse with at least 3 years of experience in multiple myeloma patient care, (3) successfully completed the accredited My Well Plan (Be Well Plan) Train-the-Trainer program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Prospective participants reporting elevated depression or anxiety symptoms during screening questionnaire (i.e. GAD-7 great than or equal to 15 and/or PHQ-9 great than or equal to 20, and/or responses on the PHQ-9 indicating thoughts of self-harm) will be contacted by a member of the study team to clarify the aims of the program, what the participants can and can’t expect and outline topics discussed.
The purpose of this contact is to confirm informed consent regarding participation, including that the MyWell program is a supportive wellbeing intervention and is not a substitute for psychological therapy, crisis care, or other indicated mental health treatment.
As such, participants will be ineligible if they:
(1) actively decide not to participate upon receiving detailed information about the program
(2) if they verbally express suicidal ideation upon receiving information about the program provided during the phone conversation. If this is the case, they will be informed that the program may not be suitable for them at this point and they will be referred to further support options, including Lifeline (13 11 14), the Suicide Call Back Service (1300 659 467), and the Myeloma Australia Support Line (1800 693 566).
If a participant remains willing to proceed and confirms their understanding of the scope and limits of the program, they may elect to participate in the study.
Upon completion of the consent form and eligibility survey, all participants will receive help-seeking resources which they can save as a PDF in case further support is required.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using stratified blocked randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
5/03/2026
Date of last participant enrolment
Anticipated
Actual
1/04/2026
Date of last data collection
Anticipated
25/02/2027
Actual
Sample size
Target
100
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321898 0
Government body
Name [1] 321898 0
Department of Health, Disability and Ageing - Medical Research Future Fund (MRFF)
Country [1] 321898 0
Australia
Primary sponsor type
University
Name
Adelaide University
Address
Country
Australia
Secondary sponsor category [1] 324761 0
University
Name [1] 324761 0
University of the Sunshine Coast
Address [1] 324761 0
Country [1] 324761 0
Australia
Secondary sponsor category [2] 324764 0
University
Name [2] 324764 0
Flinders Universty
Address [2] 324764 0
Country [2] 324764 0
Australia
Secondary sponsor category [3] 324765 0
University
Name [3] 324765 0
University of Technology Sydney
Address [3] 324765 0
Country [3] 324765 0
Australia
Other collaborator category [1] 283951 0
Charities/Societies/Foundations
Name [1] 283951 0
Myeloma Australia
Address [1] 283951 0
Country [1] 283951 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320439 0
Bellberry Human Research Ethics Committee G
Ethics committee address [1] 320439 0
Ethics committee country [1] 320439 0
Australia
Date submitted for ethics approval [1] 320439 0
17/12/2025
Approval date [1] 320439 0
23/02/2026
Ethics approval number [1] 320439 0

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

Contacts
Principal investigator
Name 150486 0
Dr Matthew Iasiello
Address 150486 0
Adelaide University, North Terrace, ADELAIDE, SA 5005, Australia
Country 150486 0
Australia
Phone 150486 0
+61431246122
Fax 150486 0
Email 150486 0
[email protected]
Contact person for public queries
Name 150487 0
Matthew Iasiello
Address 150487 0
Adelaide University, North Terrace, ADELAIDE, SA 5005, Australia
Country 150487 0
Australia
Phone 150487 0
+61431246122
Fax 150487 0
Email 150487 0
[email protected]
Contact person for scientific queries
Name 150488 0
Matthew Iasiello
Address 150488 0
Adelaide University, North Terrace, ADELAIDE, SA 5005, Australia
Country 150488 0
Australia
Phone 150488 0
+61431246122
Fax 150488 0
Email 150488 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Direct to research team via email: [email protected]

Are there extra considerations when requesting access to 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.