None listed
Conditions
Brief summary
Brief description of the study purpose This study aims to evaluate whether a structured psychological skills program (the MyWell program) can improve mental health and wellbeing for people living with multiple myeloma. Who is it for? You may be eligible for this study if you are an adult living in Australia aged 18 years or older who have been diagnosed with multiple myeloma or smouldering myeloma and are able to participate in an online program. Study details Participants who are eligible will be randomly assigned to one of two groups. One group will take part in a seven session online psychological wellbeing program delivered via Zoom, where they will learn practical skills such as mindfulness, coping strategies, and ways to manage thoughts and emotions. Sessions are delivered in small groups by experienced myeloma nurses, and participants will also receive a workbook to support their learning. The other group will receive usual support resources, such as information sheets and access to support services, during the first phase of the study, and may access the program later. Participants will complete questionnaires about their mental health, including symptoms of anxiety and depression, as well as overall wellbeing and quality of life. It is hoped this research will show whether a structured, nurse led psychological program can improve mental health outcomes and provide better support for people living with myeloma.
Interventions
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 ses
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.
Sponsors
Adelaide University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed