Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy

The goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based intervention (MBI) reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy.

The main questions it aims to answer are:

* Does an online MBI intervention reduce stress levels (measured through the Perceived Stress Scale) among participants? * Does an online MBI 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 MBI to no intervention to see if online MBI reduces treatment-related stress.

Participants will:

* Participate in an online MBI or no intervention for 6 weeks * Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stress

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Zambrano Hellion

San Pedro Garza García, Nuevo León, 66278, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female sex
Age ≥18 years
Diagnosis of non-metastatic breast cancer
Treatment with neoadjuvant or adjuvant chemotherapy or plan to start chemotherapy in <4 weeks
Internet access at home or in their mobile phone
Availability to participate in the online MBI 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

Treatment and study plan

Online mindfulness-based stress reduction

Other

The online MBI 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) and meditation.

Primary outcomes

Stress

Time frame: 11 weeks

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 14-26 points, and a high stress level is considered when obtaining >27 points.

Sponsors and collaborators

Lead sponsor

Medicos e Investigadores en la Lucha contra el Cancer de Mama

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 2, 2024
Registry last updated: Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed