ADDRESSING THE SIDE EFFECTS OF ENDOCRINE THERAPY: A NEW CARE PATHWAY COMBINING DIGITAL SUPPORT AND HUMAN EXPERTISE

Dr Maria Alice Franzoi, medical oncologist and specialist in digital health and care pathway implementation, will present the results of the HOPE study at the ESMO Congress. This clinical trial evaluated a hybrid care pathway combining a mobile application and nurse-led support to help women receiving endocrine therapy for breast cancer. The aim is to reduce the burden of treatment-related side effects, which can compromise adherence to a therapy that is essential for lowering the risk of recurrence, while strengthening patients’ confidence in managing their symptoms. Ultimately, this approach seeks to improve quality of life, access to supportive care, and long-term continuation of endocrine therapy.

Abstract No. LBA92, presented orally by Dr Maria Alice Franzoi on Monday 26 October at 8:40 a.m.

 Approximately 70 % [1] of breast cancers diagnosed worldwide are hormone receptor-positive (HR+). This means that tumour growth is driven by hormones, primarily oestrogen. In this type of cancer, endocrine therapy is prescribed following curative treatment for a period of five to ten years to reduce the risk of recurrence. Its purpose is to block the body’s natural hormone production and prevent the stimulation of any cancer cells that may remain.

Despite their proven efficacy, these treatments can be difficult to tolerate because of potentially burdensome side effects, including hot flushes, joint pain, vaginal dryness, insomnia, cognitive difficulties, and cancer-related fatigue. These symptoms often arise after patients have completed curative treatment, at a time when medical follow-up becomes less frequent, with consultations typically taking place every six months.

These side effects are a major reason for treatment discontinuation. A study [2] from the French CANTO cohort showed that 16% of women receiving tamoxifen were already failing to adhere adequately to their treatment after just one year, increasing their risk of recurrence by a factor of 2.3 compared with women who remained adherent.

"Several supportive care interventions, such as adapted physical activity and cognitive behavioural therapies, have individually demonstrated benefits in reducing symptom burden and improving adherence to endocrine therapy. However, these interventions are often fragmented and rarely delivered in a coordinated way. Until now, no study had evaluated a comprehensive pathway combining digital tools for symptom monitoring, access to educational resources, multiple supportive care programmes and personalised human support specifically designed for patients receiving endocrine therapy," explains Dr Maria Alice Franzoi, who will present the results of the HOPE study at ESMO.

Watch Dr Maria Alice Franzoi explain the study in a video presentation.

A Hybrid Care Pathway

The HOPE trial was designed to develop a truly structured care pathway combining technology and human intervention to help patients better manage their symptoms in everyday life and gain greater autonomy. Developed through a co-creation process involving both patients and healthcare professionals, the programme was designed to be realistic and easily integrated into both clinical practice and daily life.

HOPE is built around two major components. The first is a mobile application that enables regular symptom reporting, access to educational content, and scientifically validated supportive self-management programmes covering adapted physical activity, yoga, meditation and cognitive behavioural therapies. The second is personalised nurse support. Patients receive an initial consultation with a specialist nurse to identify and prioritise their most troublesome side effects and guide them towards the most appropriate support modules. When symptoms fail to improve or when limited engagement with the application is detected, nurses can proactively contact patients to understand and address any difficulties they may be experiencing.

Sponsored by Gustave Roussy, HOPE is a multicentre, randomised phase III trial evaluating the effectiveness of this hybrid pathway in reducing symptom burden, measured using questionnaires covering several symptoms commonly associated with endocrine therapy. Another endpoint assessed patients’ confidence in self-managing their symptoms. The 180 enrolled patients were randomly assigned either to the HOPE pathway or to standard care.

"One of the strengths of our study is the diversity of the women we enrolled, which closely reflects our patient population. Participants ranged in age from 29 to 87 years and represented a wide variety of educational backgrounds. More than fifteen different languages were spoken in the households of enrolled patients. These are populations that are often difficult to include in clinical studies," notes Dr Maria Alice Franzoi.

Improving Autonomy and Symptom Self-Management

Results at three months showed an average reduction in symptom burden of 3.41 points among women enrolled in the HOPE pathway compared with those receiving standard care."This improvement is consistent with our expectations but was not large enough to reach statistical significance,"explains Dr Franzoi. However, exploratory analyses suggest that patients who engaged more actively with the application experienced a greater reduction in symptom burden, with an average improvement of 4.26 points.

The study also demonstrated a significant improvement in patients’ confidence in managing their symptoms. Women supported through the HOPE pathway reported being more confident in their ability to understand, monitor and manage endocrine therapy-related side effects than those receiving usual care.

Assessment of programme implementation also yielded encouraging findings, with high levels of adoption: 66% of patients completed more than half of the supportive care programme, while 90% considered the pathway useful and well suited to their needs and said they would recommend it to other patients.

Both patients and healthcare professionals also highlighted the organisational value of the programme, viewing it as a practical and pragmatic approach to delivering personalised, structured support tailored to patients’ needs.

Participants continue to be followed for one year and retain access to the application. Several additional analyses are ongoing, including the evaluation of symptom burden at six and twelve months, the programme’s impact on adherence to endocrine therapy and objective measures of physical activity and sleep.

"This study demonstrates that it is possible to effectively support a highly diverse patient population and strengthen patients’ ability to manage treatment-related symptoms independently. These findings encourage us to continue developing this approach. A HOPE 2 study is already being prepared to provide even more personalised and longer-term support, particularly for younger women receiving intensified endocrine therapy strategies, including new modules dedicated to hot flushes and the most disabling symptoms," concludes Dr Maria Alice Franzoi.

Abstract No. LBA92

HOPE: Phase III randomized trial of a personalized digital supportive-care pathway (DP) for endocrine therapy (ET) symptoms in early breast cancer (BC).

Proffered paper session presented by Dr Maria Alice Franzoi.

Monday 26 October 2026 | 8:40 a.m.

[1]Kim, N., & Lukong, K. E. (2025).Treating ER-positive breast cancer: a review of the current FDA-approved SERMs and SERDs and their mechanisms of action. Oncology reviews, 19, 1564642.https://doi.org/10.3389/or.2025.1564642

[2]Pistilli, B., et al (2020).Serum Detection of Nonadherence to Adjuvant Tamoxifen and Breast Cancer Recurrence Risk. Journal of clinical oncology, 38(24), 2762–2772.https://doi.org/10.1200/JCO.19.01758

Claire Parisel

presse@gustaveroussy.fr

Léona Pinto

presse@gustaveroussy.fr

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Gustave Roussy

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