Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Addressing Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients

Conditions
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Breast Cancer, Depression, Anxiety, Mindfulness, Sleep Disturbance

Intervention / Treatment
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* Behavioral: Mindfulness
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness group visit<br>Participants will attend 6 weekly educational and mindfulness sessions | Behavioral: Mindfulness<br>* 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<br>* Other names: Educational video;|
| Placebo Comparator: Wait list control<br>Participants will be placed on a wait list | Behavioral: Control group<br>* Wait list control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability change across session | 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 | 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. | 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. | 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 | 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.) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral intervention, Spanish speaking, Latina, Breast Cancer, Mindfulness