Clinical trial NCT04834154: Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients
Official title: Addressing Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Depression, Anxiety
Mindfulness
Sleep Disturbance
Keywords: behavioral intervention
Spanish speaking
Latina
Breast Cancer
Mindfulness
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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

Primary outcomes:
measure: Acceptability change across session
timeFrame: End of each week for 6 weeks
measure: Difference in Feasibility
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Differences in Generalized Anxiety Disorder-7 (GAD7) between time points.
timeFrame: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
measure: Differences in Center for Epidemiological Studies-Depression (CES-D) between time points.
timeFrame: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
measure: Differences in PROMIS-SD between time points
timeFrame: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Maria G Juarez-Reyes, MD, PhD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Lisa Golman-Rosas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zich JM, Attkisson CC, Greenfield TK. Screening for depression in primary care clinics: the CES-D and the BDI. Int J Psychiatry Med. 1990;20(3):259-77. doi: 10.2190/LYKR-7VHP-YJEM-MKM2.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.