Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients

NCT04834154 | Completed

• 3 other identifiers: IRB-57111NCI-2021-06706BRS0123
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Depression, Anxiety; Mindfulness; Sleep Disturbance

Keywords

behavioral intervention; Spanish speaking; Latina; Breast Cancer; Mindfulness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Differences in Generalized Anxiety Disorder-7 (GAD7) between time points.

  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.

  Three time points (week 1 and 6 of intervention, and 3 months post intervention.)

• Differences in PROMIS-SD between time points

  Three time points (week 1 and 6 of intervention, and 3 months post intervention.)

Study Arms (2)

Mindfulness group visit

ACTIVE COMPARATOR

Participants will attend 6 weekly educational and mindfulness sessions

Behavioral: Mindfulness

Wait list control

PLACEBO COMPARATOR

Participants will be placed on a wait list

Behavioral: Control group

Interventions

Mindfulness BEHAVIORAL

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

Also known as: Educational video

Mindfulness group visit

Control group BEHAVIORAL

Wait list control

Wait list control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Related Publications (11)

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• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Akman T, Yavuzsen T, Sevgen Z, Ellidokuz H, Yilmaz AU. Evaluation of sleep disorders in cancer patients based on Pittsburgh Sleep Quality Index. Eur J Cancer Care (Engl). 2015 Jul;24(4):553-9. doi: 10.1111/ecc.12296. Epub 2015 Mar 1.

  PMID: 25727241 BACKGROUND

• Wu HS, Harden JK. Symptom burden and quality of life in survivorship: a review of the literature. Cancer Nurs. 2015 Jan-Feb;38(1):E29-54. doi: 10.1097/NCC.0000000000000135.

  PMID: 24831042 BACKGROUND

• Chen D, Yin Z, Fang B. Measurements and status of sleep quality in patients with cancers. Support Care Cancer. 2018 Feb;26(2):405-414. doi: 10.1007/s00520-017-3927-x. Epub 2017 Oct 23.

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• Carlson LE. Mindfulness-based interventions for coping with cancer. Ann N Y Acad Sci. 2016 Jun;1373(1):5-12. doi: 10.1111/nyas.13029. Epub 2016 Mar 9.

  PMID: 26963792 BACKGROUND

• Vollestad J, Nielsen MB, Nielsen GH. Mindfulness- and acceptance-based interventions for anxiety disorders: a systematic review and meta-analysis. Br J Clin Psychol. 2012 Sep;51(3):239-60. doi: 10.1111/j.2044-8260.2011.02024.x. Epub 2011 Sep 9.

  PMID: 22803933 BACKGROUND

• Hoge EA, Bui E, Marques L, Metcalf CA, Morris LK, Robinaugh DJ, Worthington JJ, Pollack MH, Simon NM. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013 Aug;74(8):786-92. doi: 10.4088/JCP.12m08083.

  PMID: 23541163 BACKGROUND

• Schell LK, Monsef I, Wockel A, Skoetz N. Mindfulness-based stress reduction for women diagnosed with breast cancer. Cochrane Database Syst Rev. 2019 Mar 27;3(3):CD011518. doi: 10.1002/14651858.CD011518.pub2.

  PMID: 30916356 BACKGROUND

• Juarez-Reyes M, Martinez E, Xiao L, Goldman Rosas L. A Randomized Controlled Trial of a Culturally Adapted, Community-Based, Remotely Delivered Mindfulness Program for Latinx Patients With Breast Cancer is Acceptable and Feasible While Reducing Anxiety. Glob Adv Integr Med Health. 2024 Aug 16;13:27536130241274240. doi: 10.1177/27536130241274240. eCollection 2024 Jan-Dec.

  PMID: 39157776 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Depression; Anxiety Disorders; Parasomnias

Interventions

Mindfulness; Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Maria G Juarez-Reyes, MD, PhD

  Stanford University

  STUDY DIRECTOR

• Lisa Golman-Rosas, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 8, 2021
• Study Start: March 15, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)