An interventional study of self-hypnosis sessions in Breast Cancer Female, sponsored by Institut de Cancérologie de Lorraine. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Institut de Cancérologie de Lorraine · Not applicable, Interventional, and Supportive care
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 :
The originality of this clinical trial is the proposal of self-hypnosis sessions over three weeks with three different themes using a digital solution.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 76 is close to the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institut de Cancérologie de Lorraine is the lead sponsor of 62 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard care
experimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily
Other: self-hypnosis sessions
3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily
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 and severity of hot flashes.
Time frame: 28 days
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
Started Dec 2024 (actual). Primary completion is estimated for Sep 2027, 33 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 33 months is close to that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 2, 2026: start Oct 2024 → Dec 2024, primary completion Apr 2027 → Sep 2027 and completion Feb 2028 → Sep 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Institut de Cancérologie de Lorraine