Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Stress
• Intervention / Treatment: Other: Online mindfulness-based stress reduction

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • San Pedro Garza García, Nuevo León, Mexico, 66278
      • Recruiting
      • Hospital Zambrano Hellion
      • Contact: Fernanda Mesa-Chavez, MD, MSc; Phone Number: +52-81-8888-0442; Email: fernanda.mesa@tecsalud.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female sex
• Age ≥18 years
• Diagnosis of non-metastatic breast cancer
• Plan to start neoadjuvant or adjuvant chemotherapy in <4 weeks
• Internet access at home or in their mobile phone
• Availability to participate in the online MBSR intervention for 6 weeks
• Availability to answer the study surveys
• Provision of signed informed consent

Exclusion Criteria:

• Disease recurrence
• Current meditation or mindfulness practice
• Inability to read or write

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will be assessed with the study surveys at baseline (T1), will participate in the online MBSR intervention for the next 6 weeks, and will be subsequently reassessed with the study surveys at 7 weeks (T2) and at 11 weeks (T3) of follow-up.	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.
No Intervention: Wait-list control group; A wait-list control group will be used with the objective that all participants have the opportunity of receiving the online MBSR intervention and at the same time allow comparison of the effectiveness of the program with a group without intervention. Given that treatment-related stress has an important negative impact on patients' wellbeing, it is appropriate to offer the control group the possibility of receiving the intervention if its effectiveness is demonstrated. The control group will be assessed with the study surveys at baseline (T1), will not participate in the online MBSR intervention for the next 6 weeks, and will be subsequently reassessed with the study surveys at the same timepoints as the intervention group at 7 weeks (T2) and at 11 weeks (T3) of follow-up. Upon completion of recruitment and follow-up of all participants, the study will end, and the control group will be able to receive the online MBSR intervention according to their preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress	Measured through the Perceived Stress Scale (PSS). The PSS is a self-report instrument that assesses the level of perceived stress over the past month. It consists of 10 items that are rated using a 5-point Likert scale (0: Never; 1: Almost never; 2: Sometimes; 3: Fairly often; 4: Very often). The total score is obtained by adding the scores of the 10 items, obtaining a total value between 0-40, where higher scores indicate a higher level of perceived stress. A moderate stress level is considered between 20-25 points, and a high stress level is considered when obtaining >25 points.	11 weeks

Collaborators and Investigators

• Sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; mindfulness-based stress reduction; chemotherapy-related stress
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: ECA-MIND-QT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No