Mindfulness for Breast Cancer

Overseen By Olivia Tigre, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must be taking: Endocrine therapy

Disqualifiers: Non-Spanish speaking, Bipolar, Psychotic, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to adapt a mindfulness program for Spanish-speaking Latina patients with breast cancer to determine its effectiveness in reducing anxiety and depression. A community health worker will receive training to lead the program, and the trial will assess its cultural fit and effectiveness. Participants will either join a mindfulness group for six weeks or be placed on a waitlist. This trial suits Latina breast cancer patients treated in the past year who experience anxiety, depression, or sleep issues. Participants must speak Spanish and be willing to attend group sessions.

As an unphased trial, this study provides a unique opportunity to contribute to culturally tailored mental health support for Latina breast cancer patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mindfulness and does not mention medication changes.

What prior data suggests that this mindfulness program is safe for Latina patients with breast cancer?

Research has shown that mindfulness techniques are generally safe for people with cancer. Many studies have found that patients respond well to mindfulness activities, like those in this trial. For instance, women with breast cancer reported feeling less upset and experiencing better mental health through mindfulness. No major reports of harmful effects or serious problems have emerged from these methods. Instead, mindfulness often helps reduce anxiety, depression, and stress, indicating its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mindfulness for breast cancer because it offers a non-invasive, holistic approach to support mental wellness alongside traditional treatments like surgery, chemotherapy, and radiation. Unlike standard medical treatments, mindfulness focuses on reducing stress and improving quality of life through mental exercises and relaxation techniques. This approach could complement existing therapies by helping patients manage anxiety and depression, potentially leading to better overall outcomes and a more positive treatment experience.

What evidence suggests that mindfulness might be an effective treatment for breast cancer?

Research has shown that mindfulness, which participants in this trial may receive, can help people with breast cancer by reducing anxiety and depression. Studies have found that mindfulness activities improve quality of life and lessen symptoms of depression and anxiety in cancer patients. One study found significant improvements in these areas, with changes being quite noticeable. Additionally, mindfulness-based cognitive therapy has demonstrated positive effects for breast cancer survivors, both mentally and physically. Overall, mindfulness practices offer a promising way to support emotional well-being in breast cancer patients. Participants in the control group will be placed on a waitlist. ^{3 6 7 8 9}

Who Is on the Research Team?

Maria G Juarez-Reyes, MD, PhD

Principal Investigator

Stanford University

Lisa Golman-Rosas, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking Latinas who have had breast cancer treatment or endocrine therapy in the last year. They must identify as having anxiety, depression, or sleep disturbances and be able to sign consent. It's not for those with other diagnoses besides invasive breast cancer, non-Spanish speakers, certain mental health conditions, inability to attend sessions, or current participation in similar programs.

Inclusion Criteria

I have been treated for breast cancer in the last 12 months.

I have not had breast cancer treatment or hormone therapy in the last year.

Self identifies as Latinx / Latina / Latino

Exclusion Criteria

I cannot attend group sessions due to physical or psychological reasons.

I am a cancer survivor not currently on any active or hormone therapy.

I am currently participating in a stress reduction or mindfulness program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 6 weekly educational and mindfulness sessions

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for changes in anxiety, depression, and sleep quality post-intervention

3 months

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Control group
• Mindfulness

Trial Overview The study tests a mindfulness program translated into Spanish and delivered by a trained community health worker. Its cultural acceptability and feasibility are evaluated alongside its effectiveness at reducing anxiety and depression among Latina breast cancer patients.

How Is the Trial Designed?

Group I: Mindfulness group visit Active Control 1 Intervention

Participants will attend 6 weekly educational and mindfulness sessions

Group II: Wait list control Placebo Group 1 Intervention

Participants will be placed on a wait list

Mindfulness is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mindfulness-Based Interventions for:

• Substance Abuse Treatment
• Anxiety Disorders
• Depression

Approved in European Union as Mindfulness-Based Stress Reduction for:

• Stress Management
• Anxiety Disorders
• Chronic Pain

Approved in Canada as Mindfulness-Based Cognitive Therapy for:

• Depression
• Anxiety Disorders
• Substance Abuse Treatment

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39291332/

Efficacy of Mindfulness-Based Stress Reduction for Breast ... Within-group effect size analysis at 26 weeks showed substantial improvements in all three groups (effect sizes >0.50) in subjective impairments ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022399925002764

Mindfulness-based interventions for cancer patients in ... Studies synthesized in this meta-analysis showed that MBIs have positive outcomes, namely increased quality of life, and reduced depression and anxiety symptoms ...

3. nature.com nature.com/articles/s41598-025-85745-1

An examination of the effectiveness of mindfulness ... Based on the results of this study, it can be concluded that MICBT therapy is effective in reducing depression, anxiety, and stress and ...

4. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-023-02486-x

Immediate impact of Mindfulness-Based Cognitive Therapy ... Mindfulness-based cognitive therapy (MBCT) may have positive physiological and psychological benefits for breast cancer survivors.

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0306643

Effects of mindfulness-based stress reduction on quality of life ... The results of the meta-analysis showed that MBSR therapy were significantly better than standard care in reducing FOR in breast cancer patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8200136/

Mindfulness-Based Interventions in Cancer Survivors Among cancer patients, multiple systematic reviews have provided evidence for the efficacy of MBIs in reducing symptoms of mood disturbance, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6436161/

Mindfulness‐based stress reduction for women diagnosed ... MBSR seems to benefit patients with mood disorders and chronic pain, and it may also benefit women with breast cancer.

8. sciencedirect.com sciencedirect.com/science/article/pii/S096522992100008X

The mindfulness-based stress reduction program for ... This study aims to evaluate the efficacy and effectiveness of a mindfulness-based stress reduction (MBSR) program in improving sleep in cancer survivors.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03972020?tab=table

Mindfulness Based Intervention vs Cognitive Behavioral ... Several systematic reviews have shown the effectiveness of MBIs in improving anxiety and depressive symptoms, sleep, fatigue, disease adaptation and stress ...