AnxietyNCT05837169
Randomized Study to Evaluate an Intervention Based on Mindfulness to Reduce Anxiety in Breast Cancer Survivors
A study testing Mindfulness-based stress reduction in people with Anxiety and Breast Cancer, run by Medicos e Investigadores en la Lucha contra el Cancer de Mama at 1 site in Mexico.
Trial summary
The diagnosis and treatment of breast cancer (BC) can drastically affect the quality of life of patients with this disease by causing symptoms of vasomotor disorders, insomnia, depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Breast Cancer, Survivorship
- What is being tested?
- Mindfulness-based stress reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteMexico
- Study dates
- 23 Sep 2021to 8 Dec 2022
- 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
- Diagnosis of stage 0-III BC
- Between 1 and 5 years after receiving the diagnosis of BC
- Not being treated with chemotherapy or radiotherapy during the duration of the study
- Score ≥10 on the GAD-7 tool (moderate to severe anxiety)
- Internet access at home
- Availability to participate in the MBSR intervention virtually for 8 weeks
- Availability to answer the follow-up questionnaires during the duration of the study
Who cannot join
- Metastatic disease
- Score <10 on the GAD-7 tool (mild anxiety)
- Current meditation 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: Randomized Study with Wait-list Control to Evaluate the Impact of a Stress Reduction Intervention Based on Mindfulness Offered Virtually to Reduce Anxiety Levels in Breast Cancer Survivors
The diagnosis and treatment of breast cancer (BC) can drastically affect the quality of life of patients with this disease by causing symptoms of vasomotor disorders, insomnia, depression and anxiety. Mindfulness-Based Stress Reduction (MBSR) is a program dedicated to fostering complete awareness in the present in order to accept the moment, thereby reducing stress. Previous studies have shown that MBSR benefits patients with chronic conditions such as mood disorders and chronic pain, as well as patients with BC. However, its usefulness in Mexican patients has not been previously studied.
Read the detailed description
This is a prospective, randomized clinical study, controlled by a wait-list group and blinded to the statistician, with the main objective of evaluating whether an MBSR intervention offered virtually allows reducing the levels of anxiety of BC survivors.
The randomized design will make it possible to compare participants' levels of anxiety, depression, fear of recurrence, and physical symptoms according to whether they participate in a virtual MBSR program or do not. In addition, the randomized design will reduce the possible impact of confounding variables, facilitating direct comparison between the two groups.
Invitation to the study will be made through social networks of Mexican civil associations and through the dissemination of the study by specialists in oncology. It will be done this way because the intervention through an online mindfulness program can be delivered to a considerable volume of BC survivors with internet access, regardless of their place of residence or medical care.
Participants will be assigned to the intervention group or the wait-list control group. Those randomized to the control group will not receive the MBSR intervention during the study period, while those randomized to the intervention group will participate in a virtual MBSR program, which is described below. A wait-list control group will be used with the aim that all participants have the opportunity to receive the MBSR intervention and at the same time allow comparison of the effect of the program with a group without intervention. Given that anxiety has a significant negative impact on people's well-being, it is appropriate to offer the control group the possibility of receiving an intervention if its effectiveness is demonstrated. The control group will be assessed with the study surveys at baseline, will not receive MBSR intervention for the following 8 weeks, and will subsequently be reassessed with the study surveys at the same time points as the intervention group. At the end of the recruitment and follow-up of all the participants, the study will end and the control group will be able to receive the MBSR intervention free of charge according to the preference of the participants.
BC survivors will be invited to participate through an electronic link with a selection questionnaire asking about the inclusion and exclusion criteria. In particular, the General Anxiety Disorder-7 (GAD-7) tool will allow for anxiety screening in order to determine if those interested in participating have the minimum level of anxiety required to be included in the study. Through that same electronic link, those who meet the eligibility criteria will be invited to read and sign the electronic informed consent. Those who accept will be randomly assigned to the intervention group or control group, in a 1:1 ratio considering a stratification according to the severity of anxiety measured by GAD-7 (moderate vs. severe) and menopausal status (pre- vs. post-menopause) in the questionnaire. of selection. Likewise, they will be asked for contact information (i.e., telephone and email) in order to send them the study surveys (participants in both groups) and the electronic links for the MBSR program sessions (participants in the intervention group). At this baseline time (T1), participants randomized to either group will answer the study surveys to assess symptoms of anxiety, depression, and fatigue.
Subsequently, the intervention group will participate in the online MBSR intervention for 8 weeks, while the control group will be registered on a waiting list and will be able to receive the intervention once the study is finished. For both the intervention group and the control group, the online MBSR program will be offered free of charge.
Participants will answer the study surveys again 1 week (T2), 3 months (T3) and 6 months (T4) after completing the online mindfulness program. In the case of participants randomized to the control group, these times correspond to 9 weeks (T2), 5 months (T3) and 8 months (T4) of follow-up. Additionally, in T2 the participants randomized to the intervention group will answer a satisfaction survey with the online MBSR program. At the end of the recruitment and follow-up of the participants, the study will end and those randomized to the control group by waiting list will be able to receive the MBSR intervention online if they wish.
- Conditions
- Anxiety, Breast Cancer, Survivorship
- Being tested
- Mindfulness-based stress reduction
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reductionOther
The control group will be assessed with the study surveys at baseline, will not receive MBSR intervention for the following 8 weeks, and will subsequently be reassessed with the study surveys at the same time points as the intervention group. At the end of the recruitment and follow-up of all the participants, the study will end and the control group will be able to receive the MBSR intervention free of charge according to the preference of the participants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The MBSR program will be offered through the Zoom platform. It consists of a total of 8 weekly sessions, with an approximate duration of 2 hours per session. During these sessions, patients will be instructed in exercises to promote mindfulness, including body awareness (body scan), gentle yoga exercises, and meditation. Additionally, a digital manual will be delivered with exercises that can be done at home, 8 audios with guided exercises and a video with balance and flexibility postures. Patients will be instructed to practice mindfulness exercises at least twice a day, lasting approximately 20 min per exercise, to cultivate the incorporation of meditation into their daily lives. Receives: Other: Mindfulness-based stress reduction |
| Wait-list control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety level, as measured by the General Anxiety Disorder-7 (GAD-7) tool. GAD-7 is a validated tool made up of 7 items that are each rated from 0-3, thus the total score can range from 0-21. A score between 10-14 suggests moderate anxiety and a score of 15-21 suggests severe anxiety. Therefore, a score ≥10 has been established as cut-off point to identify cases of anxiety.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start23 Sep 2021
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- 68 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, Cynthia Villarreal Garza, Medicos e Investigadores en la Lucha contra el Cancer de Mama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837169
- Sponsor's protocol ID
- ECA-MIND
- Status last verified
- Feb 2025
- First submitted
- 19 Apr 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrigno Guajardo A, Salazar-Alejo M, Mesa-Chavez F, Gutierrez-Ornelas J, Platas A, Verduzco-Aguirre H, Villarreal-Garza C. Effectiveness of an online mindfulness-based stress-reduction intervention to reduce anxiety in breast cancer survivors: a randomized-controlled trial. Support Care Cancer. 2025 Jun 24;33(7):623. doi: 10.1007/s00520-025-09681-6.
PubMed 40555874
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study with Wait-list Control to Evaluate the Impact of a Stress Reduction Intervention Based on Mindfulness Offered Virtually to Reduce Anxiety Levels in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05837169
- Acronym / sponsor ID
- ECA-MIND
- Conditions
- Anxiety, Breast Cancer, Survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Medicos e Investigadores en la Lucha contra el Cancer de MamaUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 1 May 2023 (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 diagnosis and treatment of breast cancer (BC) can drastically affect the quality of life of patients with this disease by causing symptoms of vasomotor disorders, insomnia, depression and anxiety. Mindfulness-Based Stress Reduction (MBSR) is a program dedicated to fostering complete awareness in the present in order to accept the moment, thereby reducing stress. Previous studies have shown that MBSR benefits patients with chronic conditions such as mood disorders and chronic pain, as well as patients with BC. However, its usefulness in Mexican patients has not been previously studied.
Detailed description
This is a prospective, randomized clinical study, controlled by a wait-list group and blinded to the statistician, with the main objective of evaluating whether an MBSR intervention offered virtually allows reducing the levels of anxiety of BC survivors.
The randomized design will make it possible to compare participants' levels of anxiety, depression, fear of recurrence, and physical symptoms according to whether they participate in a virtual MBSR program or do not. In addition, the randomized design will reduce the possible impact of confounding variables, facilitating direct comparison between the two groups.
Invitation to the study will be made through social networks of Mexican civil associations and through the dissemination of the study by specialists in oncology. It will be done this way because the intervention through an online mindfulness program can be delivered to a considerable volume of BC survivors with internet access, regardless of their place of residence or medical care.
Participants will be assigned to the intervention group or the wait-list control group. Those randomized to the control group will not receive the MBSR intervention during the study period, while those randomized to the intervention group will participate in a virtual MBSR program, which is described below. A wait-list control group will be used with the aim that all participants have the opportunity to receive the MBSR intervention and at the same time allow comparison of the effect of the program with a group without intervention. Given that anxiety has a significant negative impact on people's well-being, it is appropriate to offer the control group the possibility of receiving an intervention if its effectiveness is demonstrated. The control group will be assessed with the study surveys at baseline, will not receive MBSR intervention for the following 8 weeks, and will subsequently be reassessed with the study surveys at the same time points as the intervention group. At the end of the recruitment and follow-up of all the participants, the study will end and the control group will be able to receive the MBSR intervention free of charge according to the preference of the participants.
BC survivors will be invited to participate through an electronic link with a selection questionnaire asking about the inclusion and exclusion criteria. In particular, the General Anxiety Disorder-7 (GAD-7) tool will allow for anxiety screening in order to determine if those interested in participating have the minimum level of anxiety required to be included in the study. Through that same electronic link, those who meet the eligibility criteria will be invited to read and sign the electronic informed consent. Those who accept will be randomly assigned to the intervention group or control group, in a 1:1 ratio considering a stratification according to the severity of anxiety measured by GAD-7 (moderate vs. severe) and menopausal status (pre- vs. post-menopause) in the questionnaire. of selection. Likewise, they will be asked for contact information (i.e., telephone and email) in order to send them the study surveys (participants in both groups) and the electronic links for the MBSR program sessions (participants in the intervention group). At this baseline time (T1), participants randomized to either group will answer the study surveys to assess symptoms of anxiety, depression, and fatigue.
Subsequently, the intervention group will participate in the online MBSR intervention for 8 weeks, while the control group will be registered on a waiting list and will be able to receive the intervention once the study is finished. For both the intervention group and the control group, the online MBSR program will be offered free of charge.
Participants will answer the study surveys again 1 week (T2), 3 months (T3) and 6 months (T4) after completing the online mindfulness program. In the case of participants randomized to the control group, these times correspond to 9 weeks (T2), 5 months (T3) and 8 months (T4) of follow-up. Additionally, in T2 the participants randomized to the intervention group will answer a satisfaction survey with the online MBSR program. At the end of the recruitment and follow-up of the participants, the study will end and those randomized to the control group by waiting list will be able to receive the MBSR intervention online if they wish.
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: Mindfulness-based stress reductionThe MBSR program will be offered through the Zoom platform. It consists of a total of 8 weekly sessions, with an approximate duration of 2 hours per session. During these sessions, patients will be instructed in exercises to promote mindfulness, including body awareness (body scan), gentle yoga exercises, and meditation. Additionally, a digital manual will be delivered with exercises that can be done at home, 8 audios with guided exercises and a video with balance and flexibility postures. Patients will be instructed to practice mindfulness exercises at least twice a day, lasting approximately 20 min per exercise, to cultivate the incorporation of meditation into their daily lives. |
| Wait-list control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of stage 0-III BC
- Between 1 and 5 years after receiving the diagnosis of BC
- Not being treated with chemotherapy or radiotherapy during the duration of the study
- Score ≥10 on the GAD-7 tool (moderate to severe anxiety)
- Internet access at home
Key exclusion criteria (4 listed)
- Metastatic disease
- Score <10 on the GAD-7 tool (mild anxiety)
- Current meditation 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 |
|---|---|---|
| Mindfulness-based stress reductionThe control group will be assessed with the study surveys at baseline, will not receive MBSR intervention for the following 8 weeks, and will subsequently be reassessed with the study surveys at the same time points as the intervention group. At the end of the recruitment and follow-up of all the participants, the study will end and the control group will be able to receive the MBSR intervention free of charge according to the preference of the participants. | Other | Intervention group |
Primary outcome
Anxiety
Time frame: 8 months
Anxiety level, as measured by the General Anxiety Disorder-7 (GAD-7) tool. GAD-7 is a validated tool made up of 7 items that are each rated from 0-3, thus the total score can range from 0-21. A score between 10-14 suggests moderate anxiety and a score of 15-21 suggests severe anxiety. Therefore, a score ≥10 has been established as cut-off point to identify cases of anxiety.
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 7 Feb 2025.
- Derived from this study: PubMed 40555874Ferrigno Guajardo A, Salazar-Alejo M, Mesa-Chavez F, Gutierrez-Ornelas J, Platas A, Verduzco-Aguirre H, Villarreal-Garza C. Effectiveness of an online mindfulness-based stress-reduction intervention to reduce anxiety in breast cancer survivors: a randomized-controlled trial. Support Care Cancer. 2025 Jun 24;33(7):623. doi: 10.1007/s00520-025-09681-6.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Recruiting
TOUCHminds: Help-seeking in Adolescents With Anxiety
Anxiety Symptoms, Anxiety Disorders
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Recruiting
A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
Pain (Knee), Pain and Anxiety
Active, not recruiting
Relaxation Techniques and Pilates for Menopause Symptoms
Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
RecruitingObservational study
Evaluation of Preoperative Anxiety in Digestive Surgery
Digestive System Neoplasms, Anxiety
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 Mindfulness-based stress reduction in people with Anxiety and Breast Cancer, 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 7 inclusion and 4 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 7 Feb 2025. 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?
Anxiety (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05837169, which also lists 1 linked publication.
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 7 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.