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Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients

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Stanford University

Status

Completed

Conditions

Breast Cancer
Depression, Anxiety
Mindfulness
Sleep Disturbance

Treatments

Behavioral: Control group
Behavioral: Mindfulness

Study type

Interventional

Funder types

Other

Identifiers

NCT04834154
NCI-2021-06706 (Other Identifier)
BRS0123 (Other Identifier)
IRB-57111

Details and patient eligibility

About

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

Full 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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

31 participants in 2 patient groups, including a placebo group

Mindfulness group visit
Active Comparator group
Description:
Participants will attend 6 weekly educational and mindfulness sessions
Treatment:
Behavioral: Mindfulness
Wait list control
Placebo Comparator group
Description:
Participants will be placed on a wait list
Treatment:
Behavioral: Control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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