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Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT04834154
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Breast Cancer Depression, Anxiety Mindfulness Sleep Disturbance Behavioral: Mindfulness Behavioral: Control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Addressing Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2026

Resource links provided by the National Library of Medicine


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 Name: Educational video

Placebo Comparator: Wait list control
Participants will be placed on a wait list
Behavioral: Control group
Wait list control




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834154


Contacts
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Contact: Maria G Juarez-Reyes, MD, PhD 6504989000 mjuarezreyes@stanford.edu
Contact: Olivia Tigre, MPH 650-723-9907 otige@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Olivia Tigre, MPH    650-726-9907    otigre@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Maria G Juarez-Reyes, MD, PhD Stanford University
Principal Investigator: Lisa Golman-Rosas, PhD Stanford University
Publications:

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04834154    
Other Study ID Numbers: IRB-57111
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stanford University:
behavioral intervention
Spanish speaking
Latina
Breast Cancer
Mindfulness
Additional relevant MeSH terms:
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Breast Neoplasms
Dyssomnias
Parasomnias
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders