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Mindfulness for Breast Cancer
N/A
Waitlist Available
Led By Lisa Golman-Rosas, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Comorbid bipolar affective disorder or psychotic disorder
Other diagnosis besides invasive breast cancer (ie Ductal carcinoma in situ (DCIS), fibroadenoma, abnormal mammogram but not yet with final diagnosis, non-breast cancer patients)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Summary
This trial is testing a mindfulness program to see if it can help Latina breast cancer patients with anxiety and depression.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves a mindfulness program rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal experiences during group sessions.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with bipolar disorder or a psychotic disorder.
Select...
I have a breast condition but it's not invasive breast cancer.
Select...
I do not speak Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability change across session
Difference in Feasibility
Secondary study objectives
Differences in Center for Epidemiological Studies-Depression (CES-D) between time points.
Differences in Generalized Anxiety Disorder-7 (GAD7) between time points.
Differences in PROMIS-SD between time points
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Mindfulness group visitActive Control1 Intervention
Participants will attend 6 weekly educational and mindfulness sessions
Group II: Wait list controlPlacebo Group1 Intervention
Participants will be placed on a wait list
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,363 Total Patients Enrolled
60 Trials studying Breast Cancer
111,018 Patients Enrolled for Breast Cancer
Lisa Golman-Rosas, PhDPrincipal InvestigatorStanford University
Maria G Juarez-Reyes, MD, PhDStudy DirectorStanford University
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Eligibility Criteria:
This trial includes the following eligibility 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.I have been treated for breast cancer in the last 12 months.I have been diagnosed with bipolar disorder or a psychotic disorder.I have not had breast cancer treatment or hormone therapy in the last year.I have a breast condition but it's not invasive breast cancer.I do not speak Spanish.You have told the researchers that you have anxiety, depression, or trouble sleeping.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness group visit
- Group 2: Wait list control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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