31 Participants Needed

Mindfulness for Breast Cancer

MG
OT
Overseen ByOlivia Tigre, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
Must be taking: Endocrine therapy
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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

Who Is on the Research Team?

LG

Lisa Golman-Rosas, PhD

Principal Investigator

Stanford University

MG

Maria G Juarez-Reyes, MD, 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
See 3 more

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.
See 3 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: Mindfulness group visitActive Control1 Intervention
Group II: Wait list controlPlacebo Group1 Intervention

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

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Approved in United States as Mindfulness-Based Interventions for:
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Approved in European Union as Mindfulness-Based Stress Reduction for:
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Approved in Canada as Mindfulness-Based Cognitive Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+
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