Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients

March 11, 2025 updated by: Stanford University

Addressing Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary aims of this study are to: 1) translate a behavioral health intervention into Spanish, 2) deliver it to a population of Spanish speaking Latina breast cancer patients, and 3) determine acceptability and feasibility. Secondary aims are to gather preliminary data on anxiety, depression and sleep quality pre and post intervention.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Self reported diagnosis of invasive breast cancer who has currently or within last 12 months been in active treatment (surgery, chemotherapy, or radiation) or on endocrine therapy
  • Self-identified anxiety (persistent worry or nervousness), depression (feeling sad, little interest or pleasure in doing things or hopeless), or sleep disturbance.
  • Breast cancer related treatment (surgery, radiation, chemotherapy) or endocrine therapy within the last 12 months
  • Self identifies as Spanish speaking
  • Self identifies as Latinx / Latina / Latino
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Non-Spanish speaking
  • 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)
  • comorbid bipolar affective disorder or psychotic disorder (as self-identified by patient after asking "do you have any other psychiatric conditions")
  • inability to physically or psychologically attend group sessions, and by discretion of the study coordinator.
  • Patients currently participation in stress reduction or mindfulness groups/interventions will be excluded from participation
  • Cancer "survivors" if not in active or endocrine treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mindfulness group visit
Participants will attend 6 weekly educational and mindfulness sessions
Behavioral: Mindfulness
6 weekly 2.0 hour video-conferenced group sessions with the following components: 1) short grounding meditation, 2) check in/review of prior weeks practice and symptoms, 3) educational topic, 3) main meditation, 4) reflection on meditation, and 5) action plan formation
Other Names:
  • Educational video
Placebo Comparator: Wait list control
Participants will be placed on a wait list
Behavioral: Control group
Wait list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability change across session
Time Frame: End of each week for 6 weeks
The Acceptability scale was developed for this study and is a 5 point Likert scored scale that will be administered after end of each weeks for 6 weeks. There are two questions with scores ranging from "strongly disagree" (score 0), "disagree" (score 1), "neutral" (score 2), "agree" (score 3), and "strongly agree" (score 4). Scores range from 0 to 8 with the higher scores representing greater levels of acceptability. It has 2 additional open ended questions: "What changes did you make in your daily routine as a result of this intervention, if none, why" and "Were there any barriers to making changes you listed on your action plan, if so what were they? The scale takes approximately 5 minutes to complete. Acceptability change will be measured after each session (week 1-6). The mean score with standard deviation for each 6 sessions and acceptability will be reported.
End of each week for 6 weeks
Difference in Feasibility
Time Frame: Through study completion, an average of 1 year
The Feasibility and Satisfaction scale was developed for this study and is a 5 point Likert scored scale that will be administered at at time of completion of intervention or at time of withdraw (if participant withdraws prior to completion of intervention.) Five questions are scored from "strongly disagree" (score 0), "disagree" (score 1), "neutral" (score 2), "agree" (score 3), and "strongly agree" (score 4). Scores range from 0 to 20 with higher scores representing greater levels of feasibility. Differences in Feasibility will be evaluated and reported. There is also 1 open-ended question "What is the optimal number of visits" with continuous numeric score (participants able to write in number of preferred visits) with higher score representing desire for greater number of visits. The scale takes approximately 5-10 minutes to complete
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Generalized Anxiety Disorder-7 (GAD7) between time points.
Time Frame: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
The GAD7 is a well validated seven-item self-administered questionnaire used to measure anxiety. It has 7 questions with Likert scores ranging from "not at all" (score 0), "several days" (score 1), "more than half the days" (score 2), and "nearly every day (score 3).Scores range from 0 to 21 with higher scores indicating higher levels of anxiety, and a cutoff of or above 10 representing high likelihood of generalized anxiety disorder. Difference in GAD-7 measured at three time points (week 1 and 6 of the intervention and 3 months post intervention) will be compared and reported. The scale takes approximately 5-10 minutes to complete
Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
Differences in Center for Epidemiological Studies-Depression (CES-D) between time points.
Time Frame: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
The CES-D scale is a well validated self-administered questionnaire used to measure depression. The 20 item scale has Likert scores ranging from "rarely or none of the time" (score 0), "some or little of the time" (score 1), "moderate or much of the time" (score 2), and "most or almost all the time" (score 3).Scores range from 0 to 60 with higher scores indicated greater depressive symptoms. A cut off at or above 20 has sensitivity 79% and specificity of 80% for major depression. Difference in CES-D measured at three time points (week 1 and 6 of the intervention and 3 months post intervention) will be reported and compared. The scale takes approximately 5-10 minutes to complete.
Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
Differences in PROMIS-SD between time points
Time Frame: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
The Participant Reported Outcomes Measurement Information System (PROMIS) Adult Short Form: Sleep Disturbance (PROMIS-SD), is an 8 item scale measuring overall sleep quality, disturbances, and satisfaction over the past 7 days on 5 point Likert scale with scores ranging from 1 to 5. Raw scores are converted into t scores ranging from 28.9 to 76.5, with higher scores indicating greater sleep disturbance. Exploratory analysis will compare scores at three time points (week 1 and 6 of the intervention and 3 months post intervention). The scale takes approximately 2 minutes to complete 26 and is available in Spanish.
Three time points (week 1 and 6 of intervention, and 3 months post intervention.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Study Director: Maria G Juarez-Reyes, MD, PhD, Stanford University
  • Principal Investigator: Lisa Golman-Rosas, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

June 16, 2022

Study Completion (Actual)

June 16, 2022

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

April 2, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-57111
  • NCI-2021-06706 (Other Identifier: Clinical Trials Reporting Program (CTRP))
  • BRS0123 (Other Identifier: Stanford OnCore Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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