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Testing the MySurvivorCare website: An online tool to help breast cancer survivors manage hot flushes and night sweats after cancer

Randomised Controlled Feasibility and Pilot Trial for an Online Patient-driven Stepped-care (MySurvivorCare) Website for Managing Vasomotor Symptoms after Cancer (and GP sub study).

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000273381
Enrollment
146
Registered
2026-03-04
Start date
2026-04-01
Completion date
2026-05-31
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In Australia, many cancer survivors live with bothersome vasomotor symptoms (i.e., hot flushes and night sweats) after cancer treatment. These symptoms can affect daily life. Although supportive treatments exist, barriers such as geographical location, limited specialist clinics hinder accessibility. To address this, efficient models of care to improve access to existing healthcare services are necessary. The MySurvivorCare website, an online health tool designed to help cancer survivors manage hot flushes and night sweats after cancer, was developed to address the unmet. Why this study? This study aims to find out whether it is feasible to conduct a large trial of the MySurvivorCare website before it is launched or made publicly available. Who is it for? You may be eligible for this study if you are a breast cancer survivor and are experiencing hot flushes/night sweats. Study details Participants in this study will be, by chance, allocated to use either the MySurvivorCare website or be provided with access to menopause information from the Australasian Menopause Society website. The MySurvivorCare website will provide users with a self-help guide and information to provide to your GP regarding how to manage symptoms according to the current best practice guidelines. The Australasian Menopause Society website provides educational resources on menopause, including how best to manage symptoms. Participants will be followed up for 6 months via questionnaires. It is hoped that this study will assess how acceptable and easy to use the MySurvivorCare website is, and whether it shows early signs of helping women manage their symptoms over time.

Interventions

The intervention is called MySurvivorCare website. The MySurvivorCare intervention is a patient-driven stepped-care website. The website includes VMS symptom assessment tool, personalised reports and recommendations, informational and interactive materials such as educational content on VMS after cancer, downloadable and printable letters and clinical summaries, and a cognitive behavioural therapy (CBT)–based self-help guide for VMS management. Participants create an account using a Google or

The intervention is called MySurvivorCare website. The MySurvivorCare intervention is a patient-driven stepped-care website. The website includes VMS symptom assessment tool, personalised reports and recommendations, informational and interactive materials such as educational content on VMS after cancer, downloadable and printable letters and clinical summaries, and a cognitive behavioural therapy (CBT)–based self-help guide for VMS management. Participants create an account using a Google or Microsoft account, and complete baseline demographic and cancer-related clinical information. Users then assess the impact of hot flushes and night sweats on daily life using the validated 10-item Hot Flushes–Related Daily Interference Scale (HFRDIS). Based on their HFRDIS score, users are categorised as having mild, moderate, or severe symptom impact and are directed to personalised, stepped-care recommendations. Users may reassess symptoms over time and step up or down levels of care depending on symptom response. The MySurvivorCare website was developed by researchers and clinicians from the University of Melbourne, Western Sydney University, the University of Western Australia, and Peter MacCallum Cancer Centre, with input from consumer organisations and consumer advisory groups. The MySurvivorCare website intervention is delivered online and is self-directed. Content is accessed individually and asynchronously, allowing users to engage with the platform at times convenient to them. The intervention is delivered remotely through an online platform and can be accessed from any location with internet connectivity, including urban, regional, rural, and remote settings. Participants can access the MySurvivorCare website at any time during the study period. The intervention is tailored based on symptom impact as determined by HFRDIS scores. The intervention arm “MSC participants” with mild symptoms will be directed to a CBT self-help guide for management. The self-help guide is a 4-week self-help, resource designed to empower users to build the skills needed to effectively manage those troublesome-hot flushes and night sweats. The guide begins with a “Be Informed and Reduce Stress” section, which introduces menopause, explains what hot flushes are, and provides guidance on relaxation and paced breathing techniques, as well as strategies for monitoring and reducing triggers. Week 2 focuses on managing hot flushes in more depth, including understanding the role of thoughts and behaviours, practising relaxation techniques, and continuing to monitor and reduce triggers. Week 3 addresses night sweats and sleep, providing information about sleep, guidance on improving sleep habits, introducing sleep scheduling, exploring beliefs about sleep, and offering strategies for dealing with worries. Week 4 serves as a review and consolidation module, covering the menopause transition, reactions to cancer and its treatment, coping with uncertainty, maintaining changes, and developing a personalised maintenance plan. Throughout the programme, participants complete structured activities such as symptom and trigger monitoring, practising relaxation and paced breathing exercises, identifying and challenging unhelpful thoughts, implementing sleep scheduling, managing worries, and creating a long-term maintenance plan. MSC participants directed to the CBT-based self-help guide will be advised to engage with the resource over 4-week period. MSC participants will be advised to dedicate approximately 30 minutes each day, at any time that works for them, plus an additional one hour per week for a treatment session. The one-hour treatment session will consist of a structured review of the self-help material and the participant’s experience of working through it. During this session, key concepts from the guide will be revisited, including managing hot flushes, sleep strategies, and cognitive and behavioural techniques. The participant will have the opportunity to reflect on the activities completed, discuss any challenges encountered, and clarify any aspects of the material. The session will also focus on reinforcing the skills learned, supporting continued use of relaxation and behavioural strategies, and strengthening the maintenance plan to promote long-term symptom management. •MSC participants with moderate symptoms will be provided with a downloadable, emailable and printable platform-generated reports, letters, guidelines and will be advised to share the recommendations with their GPs, to facilitate a personalised care plan. The generated reports outlines their vasomotor symptom assessment results. The introductory letter explains that the participant accessed the MySurvivorCare website to assess their vasomotor symptoms and that the assessment identified moderate symptom interference, and that GP-led management was recommended. To equip GP with symptom management, the letter includes links to several key evidence-based clinical guidelines and resources to support GP management. These include the 2024 updated NICE guideline on menopause identification and management; the Practitioner’s Toolkit for Managing Menopause developed by Monash University (updated 2025); a 2024 Lancet review on managing menopause after cancer; a 2024 Lancet clinical framework on optimising health after early menopause; and the Menopause Quick 6 (MQ6) Interactive Treatment Algorithm for healthcare professionals. Treatment guidance resources are also provided, resources on guidance on menopausal hormone therapy dosing, non-hormonal treatment options information, and complementary therapies and lifestyle changes. The letter also notes that the participants has been granted access to an online cognitive behavioural therapy (CBT) platform for self-management strategies to practise at home. Participants are explicitly asked to discuss their results with their GP. While participants are not informed about the exact timeframe to share this recommendation, it clearly directs participants to arrange a discussion with their GP following receipt of their results so that appropriate GP-led management can be initiated. • MSC participants with severe symptoms will be provided with platform-generated reports and letters, which can be downloaded, emailed, or printed. The platform-generated reports and letters are largely the same in structure and content as those for moderate symptoms, but with a key difference in the management recommendation. As with the moderate group, participants receive a summary of their results, and a letter is generated for their GP explaining that the patient accessed the MySurvivorCare website and completed a menopause symptom assessment. The letter outlines that symptoms are causing severe interference and recommends GP-led management; however, in contrast to the moderate pathway, it additionally states that non-GP medical specialist-guided management may be initiated if needed. The same suite of evidence-based clinical guidelines and treatment resources is provided to support management, and participants are also granted access to the online cognitive behavioural therapy (CBT) platform for self-management strategies. Importantly, for severe symptoms, the letter includes information about referral options to non-GP medical specialists, such as gynaecologists, reproductive endocrinologists, general menopause specialists, or Specialist Menopause After Cancer clinics, and provides examples of relevant specialist services. Participants with severe symptoms are asked to discuss their results with their GP. However, as with the moderate symptom pathway, participants are advised to share and discuss the results with their GP so that appropriate GP-led or specialist-guided management can be arranged, but it does not mandate a defined timeframe for doing so. MSC participants within the moderate and severe group will also be granted access to the CBT- based self-help resources to build the skills needed to effectively manage their symptoms. Access is provided for use while awaiting GP or specialist consultations and may also be used alongside prescribed treatments. MSC participants will be advised that VMS management takes time, and most approaches need 4–8 weeks before they will notice real changes, therefore we recommend they give any self-help guide and any treatment provided by their GPs and/or specialists time to work. A total of 63 participants will have access to the MySurvivorCare website for the full duration of the study period. No modifications to the intervention will be made during the trial period. Intervention fidelity is supported through automated delivery of standardised assessments, scoring algorithms, and recommendation pathways embedded within the platform. Intervention adherence and fidelity will be assessed by monitoring participant engagement with the platform and completion of symptom reassessments at specified time points. A nested qualitative GP sub study will also be conducted in the trial. A qualitative study will adopt in-depth one-on-one online interviews. In line with standard participants recruitment in qualitative research, GP recruitment will continue until data adequacy (i.e., information redundancy) is achieved. This will not require pre-defined sample size calculations; instead, this will be determined when three consecutive interviews yield no new themes. Based on prior experience, up to 20 GPs will be interviewed on their acceptability, and the enablers and barriers to implementing its recommendations and resources. Participants in the intervention (“MSC participants”) will be requested to invite their GPs, whom they shared the recommendations with, to participate in the sub-study. If a GP agrees, the MSC participant will be requested to directly invite the GP to the study during their visit or via email or the team will provide the MSC participants with an invitation letter to share with their GP via their preferred method of communication. The letter will be a clear explanation of the study's purpose and importance, and how GP participation could benefit managing menopause in women living with and beyond cancer. This letter will also have a QR code with instructions about how to express interest and participate. The interview guide was developed by the research team . One exploratory question will be asked about GP’s acceptability of the MSC platform, and seven (7) questions will probe various aspects of the GP's experience with managing menopausal symptoms in cancer survivors and experience with the recommendation from the MSC website. For example: 'How would you describe your experience with managing menopause after cancer?', 'What was your initial reaction to receiving these recommendations?', 'Did you agree with the platform's assessment that specialist care or seeing a GP to manage the symptoms was needed?', 'How familiar were they with the management approaches suggested by the platform?' 'Did they have the skills or expertise needed to implement the platform's recommendations?' 'How did they incorporate the platform's suggestions into their decision-making?' Interview recordings will be transcribed verbatim by Trint, an artificial intelligence platform which converts audio to text. The use of Trint has been reviewed through UoM’s Privacy Impact Assessment process (PIA0601-2020, 8/7/21) and judged to be at-least medium risk from a privacy perspective, low-risk from information security perspective and low-risk in terms of records assessment perspective. Any identifiable clinics or names will be anonymised manually. Two members of the research team will double-check the transcription accuracy, then recordings will be deleted from Trint. Interviews and analysis will be conducted simultaneously using QSR NVivo 12. The overall study duration is approximately eight (8) months from commencement of recruitment to completion of final follow-up.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Primary Trial ‘Women participants’: Women cancer survivors with VMS (i.e., hot flushes and night sweats) after cancer To be eligible women participants must: 1. Be breast cancer survivors. 2. Have undergone or are undergoing breast cancer treatment. 3. Be amenorrhoeic for at least 12 months. 4. Be experiencing any (bothersome or non-bothersome) VMS (hot flushes and/or night sweats). 5. Have had VMS at least one day over 2 weeks period. 6. Seeking treatment for VMS 7. Be aged over 18. 8. Be able to give informed written consent. 9. Understand and speak English. 10. Currently live in Australia. GP-substudy GP participants’: GPs who are involved in the management of women living with and beyond breast cancer experiencing vasomotor symptoms who have been recruited to the feasibility study. To be eligible GP participants must: 1. Be registered with valid license issued by Australian Health Practitioner Regulation Agency (AHPRA). 2. Be currently practicing and have at least one year of clinical experience in treating or managing menopausal symptoms in after cancer treatment. 3. Have managed breast cancer survivors with vasomotor symptoms who were part of the feasibility/pilot study. 4. Currently work in Australia. 5. Be able to give informed written consent

Exclusion criteria

Primary Trial ‘Women participants’: Women cancer survivors with VMS (i.e., hot flushes and night sweats) after cancer They are excluded if: 1. They are not experiencing vasomotor symptoms. 2. Non-breast cancer survivors. [Note: While the MSC platform has been designed for all women with lived experience of cancer, this current study is limited by time constraints of a PhD program. Given this, the study has been designed to be focused and feasible within the given timeframe, hence, the focus on a single tumour group. Breast cancer was chosen as it is common, has high survival rate and many experience VMS. Future work will include survivors of other tumour types] 3.They cannot read, understand or speak English. [Note: Due to lack of funding for multilingual interpreters and for translation the study documents into all possible languages, we will be excluding non-English speakers. However, there are plans to include these groups in future grant applications.] GP-substudy GP participants’: GPs who are involved in the management of women living with and beyond breast cancer experiencing vasomotor symptoms who have been recruited to the feasibility study. They are excluded if: 1. They have no experience in managing VMS. 2. They managed VMS in breast cancer survivors not involved in our feasibility and pilot RCT study.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 14, 2026