NCT06534957

Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer
• Stress

Interventions

Type	Name	Description
OTHER	Online 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.

Timeline

• Start date: 2025-09-02
• Primary completion: 2026-01-01
• Completion: 2026-04-01
• First posted: 2024-08-02
• Last updated: 2025-09-26

Locations

1 site across 1 country: Mexico