Clinical trial · Interventional
Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients
Addressing Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients
NCT04834154CI-TRIAL-00087130completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Depression, Anxiety | — | UNRESOLVED | — |
| Mindfulness | — | UNRESOLVED | — |
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Behavioral | — | UNRESOLVED |
| Mindfulness | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mindfulness group visit
- description
- Participants will attend 6 weekly educational and mindfulness sessions
- interventionNames
- Behavioral: Mindfulness
- type
- PLACEBO_COMPARATOR
- label
- Wait list control
- description
- Participants will be placed on a wait list
- interventionNames
- Behavioral: Control group
Primary outcomes (2)
- measure
- Acceptability change across session
- timeFrame
- End of each week for 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (11)
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- BACKGROUNDBuysse 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
- BACKGROUNDAkman 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
- BACKGROUNDWu 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
- BACKGROUNDChen 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. PMID 29058128
- BACKGROUNDCarlson 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
- BACKGROUNDVollestad 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.