Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy

N/ARecruitingNCT06552091

Institut de Cancérologie de Lorraine76 enrolled

Overview

Patients treated for breast cancer with hormone therapy (HT) suffer from hot flashes. This side effect impacts treatment adherence. Indeed, approximately 50% of women take less than 80% of the prescribed dose, and up to 50% abandon their treatment before the fifth year of prescription, significantly increasing the risk of recurrence. Moreover, these hot flashes strongly impact the quality of life. According to the CANTO study, these hot flashes can persist up to two years after diagnosis, affecting social relationships, return to work, and physical and mental health. Some side effects resulting from HT (sleep disturbances, fatigue, hot flashes) could be alleviated by a non-pharmacological approach involving the patient. Our hypothesis is that a non-pharmacological solution, such as the use of self-hypnosis, could reduce hot flashes and the side effects related to HT or the perception thereof in patients treated for breast cancer. Consequently, this could improve the quality of life and lead to better treatment adherence. The principal objective is to evaluate the effect of daily guided self-hypnosis sessions in reducing hot flashes in patients with non-metastatic breast cancer receiving anti-aromatase hormone therapy. The secondary objectives are to evaluate : * Patient adherence to guided self-hypnosis via a digital solution * Quality of life * Sleep quality * Satisfaction with care * Usability of the digital tool The originality of this clinical trial is the proposal of self-hypnosis sessions over three weeks with three different themes using a digital solution.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient, * WHO ≤ 2, * Patient who is premenopausal, perimenopausal, or postmenopausal at diagnosis, * Patient being treated for non-metastatic breast cancer, * Ongoing adjuvant endocrine therapy, with or without concomitant anti-CDK 4/6 targeted therapy, * Patient reporting at least 50 hot flashes per week or at least 7 hot flashes per day * Patient has a computer device capable of accessing the self-hypnosis program link, * Information provided and informed consent signed, * Patient affiliated with the social security system. Exclusion Criteria: * Male, * Patient with hearing impairments, * Patient with psychotic and/or cognitive disorders As assessed by the clinician, * Patient who does not understand the French language, * Patient not diagnosed with non-metastatic breast cancer, * Patient not undergoing anti-aromatase treatment, * Patient reporting fewer than 50 hot flashes per week or fewer than 7 hot flashes per day, * Prior participation in a hypnosis or self-hypnosis program before inclusion, * Patient participating in a therapeutic program related to hot flashes, * Patient already included in another therapeutic trial on the same topic, * Patient already included in another therapeutic trial with an experimental drug, * Pregnant or breastfeeding woman, * Patient deprived of liberty (including guardianship and curatorship).

Outcomes

Primary Outcomes

Hot Flash Score (HFS)

In each group (standard and hypnosis), hot flashes will be primarily assessed using the Hot Flash Score (HFS) \[Elkins et al. 2013\], calculated through daily measurements as follows: HFS = frequency × average severity of hot flashes, where severity is rated from 1 to 4 (1: mild, 2: moderate, 3: severe, 4: very severe). The weekly HFS is calculated by averaging the daily HFS scores for each patient. Secondly, we will also evaluate the effect of guided self-hypnosis in reducing the frequency of hot flashes.

Time frame: 28 days

Secondary Outcomes

Patient adherence

calculated from the data automatically recorded by the digital solution software. Adherence is thus evaluated by the rate of session follow-ups, estimated by the proportion of patients who followed all the recommended sessions without interruption, for the hypnosis group only.

Time frame: 28 days

Score of quality of life

Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at Day 0 and Day 28. The global score ranges from 0 to 100. For each question the scale ranges from 0 = not at all to 4 = a lot.

Time frame: 28 days

Sleep quality

Evaluated using the Pittsburgh Sleep Quality Index questionnaire score at Day 0 and Day 28. The global score ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.

Time frame: 28 days

Patient satisfaction

Assessed at Day 28 using a numerical scale. The numerical scale ranges from 0 = not satisfied to 10 = very satisfied.

Time frame: 28 days

Usability of the digital tool

Assessed at Day 28 using the System Usability Scale questionnaire score (Gronier \& Baudet, 2021) for the hypnosis group only. It's composed of 10 questions on a scale from 0 = strongly disagree to 5 = strongly agree

Time frame: 28 days

Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts