Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552091
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Anti-Aromatase Hormone Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Anti-Aromatase Hormone Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYBOU
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None