Breast CancerNCT06534957
Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy
A study testing Online mindfulness-based stress reduction in people with Breast Cancer and Stress, run by Medicos e Investigadores en la Lucha contra el Cancer de Mama at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Stress
- What is being tested?
- Online mindfulness-based stress reduction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteMexico
- Study dates
- 2 Sep 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Disease recurrence
- Current meditation or mindfulness practice
- Inability to read or write
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Zambrano Hellion
San Pedro Garza García, Nuevo León, 66278
About this study
Official title: 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 intervention (MBI) reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy.
The main questions it aims to answer are:
Read more
- 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
- Conditions
- Breast Cancer, Stress
- Being tested
- Online mindfulness-based stress reduction
- Keywords
- breast cancer, mindfulness-based intervention, mindfulness, online mindfulness, chemotherapy-related stress, treatment-related stress
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online mindfulness-based stress reductionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will be assessed with the study surveys at baseline (T1), will participate in the online MBI 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. Receives: Other: Online mindfulness-based stress reduction |
| Wait-list control group | No intervention | A wait-list control group will be used with the objective that all participants have the opportunity of receiving the online MBI 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 MBI 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 MBI according to their preference. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 14-26 points, and a high stress level is considered when obtaining >27 points.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start2 Sep 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicos e Investigadores en la Lucha contra el Cancer de Mama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Mesa-Chavez, Tecnologico de Monterrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534957
- Sponsor's protocol ID
- ECA-MIND-QT
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Mindfulness-based Stress Reduction Intervention for Patients With Breast Cancer Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT06534957
- Acronym / sponsor ID
- ECA-MIND-QT
- Conditions
- Breast Cancer, Stress
- Keywords
- breast cancer, mindfulness-based intervention, mindfulness, online mindfulness, chemotherapy-related stress, treatment-related stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Medicos e Investigadores en la Lucha contra el Cancer de MamaUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Online mindfulness-based stress reductionThe intervention group will be assessed with the study surveys at baseline (T1), will participate in the online MBI 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. |
| Wait-list control group | No intervention | –A wait-list control group will be used with the objective that all participants have the opportunity of receiving the online MBI 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 MBI 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 MBI according to their preference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Disease recurrence
- Current meditation or mindfulness practice
- Inability to read or write
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online mindfulness-based stress reductionThe 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. | Other | Intervention group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online mindfulness-based stress reduction in people with Breast Cancer and Stress, run by Medicos e Investigadores en la Lucha contra el Cancer de Mama at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.