Breast CancerNCT04834154
Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients
A study testing Mindfulness in people with Breast Cancer and Depression, Anxiety, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Depression, Anxiety, Mindfulness
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 16 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients
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
Read the 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.
- Conditions
- Breast Cancer, Depression, Anxiety, Mindfulness, Sleep Disturbance
- Being tested
- Mindfulness, Control group
- Keywords
- behavioral intervention, Spanish speaking, Latina, Breast Cancer, Mindfulness
- Medical subject headings
- Breast Neoplasms, Depression, Anxiety Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Also called Educational video
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
Control groupBehavioural
Wait list control
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness group visit | Active comparator | Participants will attend 6 weekly educational and mindfulness sessions Receives: Behavioral: Mindfulness |
| Wait list control | Placebo comparator | Participants will be placed on a wait list Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Differences in Generalized Anxiety Disorder-7 (GAD7) between time points.
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
Measured: 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.
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.
Measured: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
Differences in PROMIS-SD between time points
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.
Measured: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Mar 2021
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria G Juarez-Reyes, MD, PhD, Study director, Stanford UniversityLisa Golman-Rosas, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834154
- Sponsor's protocol ID
- IRB-57111
- Other IDs
- NCI-2021-06706, BRS0123
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2265888Spitzer 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.
PubMed 16717171Buysse 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.
PubMed 2748771Akman 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.
PubMed 25727241Wu 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.
PubMed 24831042Chen 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.
PubMed 29058128Carlson 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.
PubMed 26963792Vollestad 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.
PubMed 22803933Hoge 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.
PubMed 23541163Schell 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.
PubMed 30916356Juarez-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.
PubMed 39157776
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04834154
- Acronym / sponsor ID
- IRB-57111
- Conditions
- Breast Cancer, Depression, Anxiety, Mindfulness, Sleep Disturbance
- Keywords
- behavioral intervention, Spanish speaking, Latina, Breast Cancer, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness group visit | Active comparator | Behavioral: MindfulnessParticipants will attend 6 weekly educational and mindfulness sessions |
| Wait list control | Placebo comparator | Behavioral: Control groupParticipants will be placed on a wait list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessAlso: Educational video6 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 | Behavioural | Mindfulness group visit |
| Control groupWait list control | Behavioural | Wait list control |
Primary outcome
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.
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
3 secondary outcomes
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.)
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.)
Differences in PROMIS-SD between time points
Time frame: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 2265888Zich 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.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 2748771Buysse 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.
- Background: PubMed 25727241Akman 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.
- Background: PubMed 24831042Wu 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.
- Background: PubMed 29058128Chen 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.
- Background: PubMed 26963792Carlson 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.
- Background: PubMed 22803933Vollestad 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.
- Background: PubMed 23541163Hoge 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.
- Background: PubMed 30916356Schell 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.
- Derived from this study: PubMed 39157776Juarez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria G Juarez-Reyes, MD, PhD study director
Stanford University
Lisa Golman-Rosas, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Breast Cancer and Depression, Anxiety, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability change across session (time frame: End of each week for 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834154, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.