Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
Study NCT ID:
NCT06534957
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy
Sponsor:
Medicos e Investigadores en la Lucha contra el Cancer de Mama
Organization:
Study Overview
Official Title:
Online Mindfulness-based Stress Reduction Intervention for Patients With Breast Cancer Receiving Chemotherapy
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based stress reduction (MBSR) intervention reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy.
The main questions it aims to answer are:
* Does an online MBSR intervention reduce stress levels (measured through the Perceived Stress Scale) among participants?
* Does an online MBSR intervention reduce anxiety, depression, insomnia, fatigue, nausea, diarrhea, constipation, pain, and peripheral neuropathy (measured through the PRO-CTCAE of the National Cancer Institute) among participants?
Researchers will compare the online MBSR intervention to no intervention to see if online MBSR reduces treatment-related stress.
Participants will:
* Participate in an online MBSR intervention or no intervention for 6 weeks
* Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up
The main questions it aims to answer are:
* Does an online MBSR intervention reduce stress levels (measured through the Perceived Stress Scale) among participants?
* Does an online MBSR intervention reduce anxiety, depression, insomnia, fatigue, nausea, diarrhea, constipation, pain, and peripheral neuropathy (measured through the PRO-CTCAE of the National Cancer Institute) among participants?
Researchers will compare the online MBSR intervention to no intervention to see if online MBSR reduces treatment-related stress.
Participants will:
* Participate in an online MBSR intervention or no intervention for 6 weeks
* Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: