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

31 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to:Translate a mindfulness program into Spanish for Latina patients with breast cancer.Train a community health worker to facilitate the mindfulness program. Determine if this program is culturally acceptable and feasible, and Obtain pilot data on the program's effectiveness in reducing anxiety and depression

Research Team

Maria G Juarez-Reyes, MD, PhD

Principal Investigator

Stanford University

Lisa Golman-Rosas, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+