Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy
Mexico128 participantsStarted 2025-09-02
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stress
Timeframe: 11 weeks
Trial details
NCT IDNCT06534957
SponsorMedicos e Investigadores en la Lucha contra el Cancer de Mama