JMIR Publications

ABSTRACT

Background:

Hot flashes are frequent and distressing adverse effects of adjuvant hormone therapy (HT) in women with non-metastatic, hormone receptor–positive breast cancer, negatively affecting health-related quality of life (HRQoL) and potentially treatment adherence. Non-pharmacological approaches, including hypnosis, have shown promising but inconsistent results. Digitally delivered guided self-hypnosis with therapist support may provide a scalable, low-risk option, but its efficacy for hot flashes in this population has not been evaluated.

Objective:

The primary objective is to evaluate the effect of daily guided self-hypnosis sessions, delivered via a digital solution, on the reduction of hot flashes in patients with non-metastatic breast cancer receiving adjuvant HT. The secondary objectives are to evaluate adherence to the programme, HRQoL, sleep quality, satisfaction with care, and usability of the digital tool.

Methods:

HYBOU is a pilot, prospective, single-centre, open-label, randomized controlled trial with two parallel arms, conducted at the Institut de Cancérologie de Lorraine, France. Women aged ≥18 years with non-metastatic breast cancer receiving adjuvant HT, with or without a cyclin-dependent kinase 4/6 inhibitor, and experiencing ≥50 hot flashes per week or ≥7 per day will be randomized 1:1 to standard care or to standard care plus digital guided self-hypnosis. The intervention is a 3-week programme delivered through the HypnoCare-solution®, in which participants practise self-hypnosis daily for approximately 20 minutes. It addresses 3 themes introduced sequentially, one per week: pleasant coolness, body-temperature regulation, and anxiety and stress management, with weekly telephone or teleconsultation contact with a hypnotherapist. The primary outcome is the weekly Hot Flash Score (HFS), derived from daily hot flash frequency and severity (graded 1-4), assessed over a baseline week (the 7 days before randomization) and the week preceding day 28. Secondary outcomes are adherence, HRQoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30), sleep quality (Pittsburgh Sleep Quality Index), satisfaction with care, and usability of the digital tool (System Usability Scale). A total of 76 evaluable participants (38 per arm) are required; 91 participants will be pre-included to account for patients not meeting inclusion criteria at randomization.

Results:

The study received a favourable opinion from the French ethics committee (Comité de Protection des Personnes Ile de France III) on September 11, 2024. The first participant was enrolled on December 20, 2024. Recruitment is planned over 30 months and is expected to end on June 20, 2027, within an overall project duration of 40 months. Results are not yet available.

Conclusions:

HYBOU will evaluate a digitally delivered, multi-thematic guided self-hypnosis programme with weekly therapist support for hot flash management during adjuvant HT for breast cancer. If effective, the findings will inform the design of a larger multicentre confirmatory trial. Clinical Trial: ClinicalTrials.gov NCT06552091 (prospectively registered on August 12, 2024); French national authorisation number (ID-RCB) 2024-A01105-42