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Trial Title:
Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Anti-Aromatase Hormone Therapy
NCT ID:
NCT06552091
Condition:
Breast Cancer Female
Conditions: Official terms:
Hot Flashes
Conditions: Keywords:
breast cancer
non-metastatic
anti-aromatase hormone therapy
hot flashes
self-hypnosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
self-hypnosis sessions
Description:
3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily
Arm group label:
Hypnosis group
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult patient,
- WHO ≤ 3,
- Patient being treated for non-metastatic breast cancer,
- Currently undergoing anti-aromatase treatment,
- Patient experiencing at least 50 hot flashes per week,
- 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,
- Patient who does not understand the French language,
- Patient not diagnosed with non-metastatic breast cancer,
- Patient not undergoing anti-aromatase treatment,
- Patient experiencing fewer than 50 hot flashes per week,
- 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).
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Boujedaini Naoual
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54500
Country:
France
Contact:
Last name:
NAOUAL NB BOUJEDAINI NAOUAL, PhD
Phone:
03 83 59 86 68
Phone ext:
8668
Email:
n.boujedaini@nancy.unicancer.fr
Contact backup:
Last name:
CECILE CHS HUIN SCHOHN, PhD
Phone:
03 83 59 86 07
Phone ext:
8607
Email:
c.huinschohn@nancy.unicancer.fr
Investigator:
Last name:
AURELIEN AL LAMBERT, MD
Email:
Principal Investigator
Start date:
September 15, 2024
Completion date:
January 15, 2027
Lead sponsor:
Agency:
Institut de Cancérologie de Lorraine
Agency class:
Other
Source:
Institut de Cancérologie de Lorraine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06552091
