Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy

NCT ID: NCT06534957

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-02
• Study Completion Date: 2026-04-30

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

Conditions

Breast Cancer; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Online mindfulness-based stress reduction

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medicos e Investigadores en la Lucha contra el Cancer de Mama

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Mesa-Chavez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Zambrano Hellion

San Pedro Garza García, Nuevo León, Mexico

Site Status: RECRUITING

Countries

Mexico

Facility Contacts

Fernanda Mesa-Chavez, MD, MSc

Role: primary

fernanda.mesa@tecsalud.mx

+52-81-8888-0442

Other Identifiers

ECA-MIND-QT

Identifier Type: -

Identifier Source: org_study_id