Breast Cancer FemaleHYBOUNCT06552091
Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy
A study testing self-hypnosis sessions in people with Breast Cancer Female, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- self-hypnosis sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2024to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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,
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54500
JEAN LOUIS MERLIN, PU-PH, +33 3 83 65 60 62, jl.merlin@nancy.unicancer.fr
CECILE HUIN SCHOHN, PhD, + 33 3 83 59 86 07, c.huinschohn@nancy.unicancer.fr
About this study
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.
Read more
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.
- Conditions
- Breast Cancer Female
- Being tested
- self-hypnosis sessions
- Keywords
- breast cancer, non-metastatic, hormone therapy, hot flashes, self-hypnosis
- Medical subject headings
- Breast Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-hypnosis sessionsOther
3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily
| Study group | Role | What they receive |
|---|---|---|
| Standard group | No intervention | standard care |
| Hypnosis group | Experimental | experimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily Receives: Other: self-hypnosis sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 28 days
Patient satisfaction
Assessed at Day 28 using a numerical scale. The numerical scale ranges from 0 = not satisfied to 10 = very satisfied.
Measured: 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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start20 Dec 2024
- Primary completion20 Sep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Standard group: standard care. * Hypnosis group: experimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AURELIEN LAMBERT, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552091
- Sponsor's protocol ID
- 2024-A01105-42
- Acronym
- HYBOU
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy
- ClinicalTrials.gov ID
- NCT06552091
- Acronym / sponsor ID
- HYBOU / 2024-A01105-42
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer, non-metastatic, hormone therapy, hot flashes, self-hypnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Standard group: standard care. * Hypnosis group: experimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily.
| Arm | Type | Receives |
|---|---|---|
| Standard group | No intervention | –standard care |
| Hypnosis group | Experimental | Other: self-hypnosis sessionsexperimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-hypnosis sessions3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily | Other | Hypnosis group |
Primary outcome
Hot Flash Score (HFS)
Time frame: 28 days
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.
5 secondary outcomes
Patient adherence
Time frame: 28 days
Score of quality of life
Time frame: 28 days
Sleep quality
Time frame: 28 days
Patient satisfaction
Time frame: 28 days
Usability of the digital tool
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AURELIEN LAMBERT, MD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-hypnosis sessions in people with Breast Cancer Female, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JEAN LOUIS MERLIN, PUPH (+33 3 83 65 60 62, jl.merlin@nancy.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot Flash Score (HFS) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.