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New treatment option for Breast Cancer Female
Official title Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy
ClinicalTrials.gov ID: NCT06552091
What this study is testing
- What it's testing
- Patients treated for breast cancer with hormone therapy (HT) suffer from hot flashes. This side effect impacts treatment adherence.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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,
You likely can't join if
- 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,
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vandœuvre-lès-Nancy, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.