RecruitingNot ApplicableNCT06534957

Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy

Online Mindfulness-based Stress Reduction Intervention for Patients With Breast Cancer Receiving Chemotherapy


Sponsor

Medicos e Investigadores en la Lucha contra el Cancer de Mama

Enrollment

200 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether an online mindfulness-based stress reduction (MBSR) program — a structured 6-week course teaching meditation and relaxation techniques — can help women with non-metastatic breast cancer manage stress and anxiety while they are undergoing chemotherapy. Chemotherapy is physically and emotionally demanding, and mindfulness has shown promise in reducing psychological distress. This study makes the program fully online for easier access. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with non-metastatic (early-stage) breast cancer - You are planning to start neoadjuvant or adjuvant chemotherapy within the next 4 weeks - You have internet access at home or on your phone - You are available to participate in the online program for 6 weeks and complete study surveys **You may NOT be eligible if...** - Your breast cancer has come back (recurrence) - You already have an active meditation or mindfulness practice - You are unable to read or write Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROnline mindfulness-based stress reduction

The online MBSR intervention sessions will be available in a website created specifically for this purpose, where each pre-recorded session will be uploaded so that each patient can begin the intervention at the same time as their chemotherapy regimen. Each session will last approximately 1 hour, for a total of 6 sessions. The topics that will be covered in these sessions include: mindfulness overview, stress and suffering, emotional regulation, meditation, management of stressful situations, self-compassion and acceptance. Participants will watch 1 session per week following the order that will be indicated on the website; patients will be encouraged to watch the sessions during their chemotherapy infusions. During these sessions, patients will be instructed in mindfulness practice and will perform targeted exercises to promote complete consciousness, including mindful body awareness (body scan), gentle yoga exercises, and meditation.


Locations(1)

Hospital Zambrano Hellion

San Pedro Garza García, Nuevo León, Mexico

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NCT06534957


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