Breast CancerNCT07208084
Project SOAR (Speaking Our African American Realities) Awakenings for Black American Women Diagnosed With Breast Cancer
A study testing Project SOAR Awakenings arm and Project SOAR comparison group in people with Breast Cancer, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The goal of this clinical trial is to test an approach to promote well-being in Black American women diagnosed with breast cancer. The main questions it aims to answer are: Can the Project SOAR (Speaking Our African American Realities) Awakenings online intervention improve depressive symptoms in Black American women… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Project SOAR Awakenings arm and Project SOAR comparison group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- identifying as a woman at least 18 years of age (not limited to cisgender Black American women);
- identifying as Black (African) American;
- diagnosed with breast cancer of any stage and any diagnosis duration;
- able to speak and read English;
- residing in the United States;
- access to the internet/Zoom.
Who cannot join
- men diagnosed with breast cancer,
- non-English speaker
- nonresident of the United States
- no internet access
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA
Los Angeles, California, 90095-1563
Annette L Stanton, PhD, 310-825-3105, astanton@ucla.edu
About this study
Official title: Project SOAR Awakenings: Randomized Controlled Trial for Black American Women Diagnosed With Breast Cancer
The goal of this clinical trial is to test an approach to promote well-being in Black American women diagnosed with breast cancer. The main questions it aims to answer are:
- Can the Project SOAR (Speaking Our African American Realities) Awakenings online intervention improve depressive symptoms in Black American women diagnosed with breast cancer?
- Can the Project SOAR (Speaking Our African American Realities) Awakenings intervention improve fatigue in Black American women diagnosed with breast cancer?
- Can the Project SOAR (Speaking Our African American Realities) Awakenings intervention improve well-being in Black American women diagnosed with breast cancer? Researchers will compare the Awakenings online intervention to a comparison condition, to see if women in the Awakenings group improve on depressive symptoms, fatigue, and well-being more than women in the comparison group. Women in the comparison condition will receive materials by mail to use on their own.
Read more
Participants will:
- be randomized (selected by chance) to take part in four Project SOAR Gatherings, which are small group, 90-minute to two-hour online discussions with other Black American women diagnosed with breast cancer and are designed to promote well-being OR to a comparison group. Rev. Dr.(Hon) Tammie Denyse, a 20-year breast cancer survivor and patient advocate, will lead the Gatherings, along with other experts.
- devote about eight hours for women in the Project SOAR Gatherings discussions and two hours for women in the comparison group.
- complete online questionnaires at the beginning of the study and one month and three months later.
- receive a box of resources (e.g., book, cup, blanket, journal) designed to promote well-being.
Read the detailed description
Recruitment of participants for the Project SOAR Awakenings trial will be conducted via the website and other social media platforms of Carrie's TOUCH (https://carriestouch.org), a nonprofit organization located in Sacramento California for Black American women diagnosed with breast cancer. The president of Carrie's TOUCH is Rev. Dr.(Hon) Tammie Denyse, the Project SOAR (Speaking Our African American Realities) Awakenings co-Principal Investigator. Recruitment also will involve announcements and a flyer to parishioner rosters of the fifth district of African Methodist Episcopal (AME) churches, which comprises 15 states and with which Rev Dr.(Hon) Denyse is affiliated.
Announcements will direct women to an email and phone number to contact if they are interested in taking part in the Project SOAR Awakenings trial. When a potential participant expresses interest in the trial via email/phone, research staff will contact her to describe the trial, summarize elements of informed consent, confirm eligibility, answer any questions, and transmit the electronic baseline questionnaire to collect demographic data and reliable and valid measures of outcome variables (i.e., depressive symptoms, fatigue, well-being) and mediators (i.e., self-compassion, cancer-related coping through emotional expression, cancer-related avoidance-oriented coping). All elements of informed consent are described at the beginning of the electronic baseline questionnaire, and contact information is provided for research staff, principal investigators, and the Institutional Review Board. At the end of the description, participants are asked to click to proceed to the baseline questionnaire if they would like to take part in the study.
Upon the completion of the baseline questionnaires, women will be randomized 1:1 via an electronic platform to the Awakenings intervention or the enhanced treatment as usual (ETAU) condition. All participants then will be mailed resources constructed to promote caring for the self, including a book (Homecoming, 2022, Bryant), an article on the Strong Black Woman schema (Denyse … Stanton, 2023), a Project SOAR personal journal, a Project SOAR cup, a Rest Deck (Rest Is Resistance, 2022, Hersey), and a Project SOAR blanket. All participants also will be compensated $100 in a gift card (e.g., Target, Amazon) for their time at the three-month assessment point.
The date and time of the first intervention session will be emailed to participants randomized to the Project SOAR Awakenings intervention, with reminder phone calls. The four Project SOAR Awakenings sessions will be conducted electronically (Zoom) in group format (10-18 participants/group) by Rev. Dr.(Hon) Denyse and another interventionist, Dr. Thea Hairston, who also is expert in psychosocial interventions with Black American women, as assisted by a doctoral candidate research staff. Leaders and participants all will identify as Black American women. One session will be conducted each week over four weeks; each session will be approximately two hours long, for a total of eight hours. Women who miss any session will be encouraged to listen to the audio-recorded session via Zoom.
With encouragement of participants to read the article on the Strong Black Woman schema prior to the session, the first session, led by Rev. Dr.(Hon) Tammie Denyse, focuses on discussing the facets of the Strong Black Woman schema (i.e., suppress emotions related to cancer, prioritize caring for others over caring for the self, resist support from other people, present an image of strength, strive to achieve with insufficient resources) and challenging the harmful facets of the schema to promote self-compassion. The session will be based on the Gathering format used in the researchers' qualitative Project SOAR research, revised for therapeutic intent. With encouragement of participants to read two chapters of the book Homecoming prior to the session, the second session also will be led by Rev. Dr.(Hon) Tammie Denyse. The session will offer foundational psychoeducation and interactional exercises on managing traumatic and stressful experiences, drawing from the book Homecoming (Bryant, 2023). The third session will be led by Dr. Thea Hairston (beloveholistic.com). Dr. Hairston employs mindful movement exercises to promote self-compassion in Black American women. Conducted by Rev. Dr.(Hon) Denyse, the fourth session will summarize and reinforce the themes of prior sessions, including making an action plan for continuing to challenge the facets of the Strong Black Woman schema and enacting self-compassion.
Intervention sessions will be audio-recorded so that participants who miss sessions can listen to them via a password-protected link; the audio-recordings will be destroyed once the study is complete. There will be no paper study materials.
Immediately after the fourth session (and at the same time for ETAU participants), participants will be sent a link to complete measures of mediators and outcomes, with reminder emails/calls as needed to promote complete data collection. Measures again will be administered electronically three months after the final intervention session, with reminder emails/calls as needed. It is estimated that each of the three assessments will require no more than 45 minutes to complete, for a potential total of 135 minutes.
All data will be collected electronically over a secure platform. To minimize risks to confidentiality, all collected data will be coded by participant number. The key to this code will be kept in a password-protected and encrypted file on a HIPAA-compliant Box account hosted by UCLA, separate from all questionnaire data. The key will be accessible only to key study personnel, and no identifying information will be shared with researchers not directly involved in the study. At the end of the study, the key will be destroyed.
Collection of names and addresses of participants is necessary in order to send the study resources (e.g., books, journal) by mail. The electronic file containing names and addresses and linking those to participant numbers will be stored separately from the rest of the data, to be accessed only by study personnel.
- Conditions
- Breast Cancer
- Being tested
- Project SOAR Awakenings arm, Project SOAR comparison group
- Keywords
- Breast Cancer, African American women, Psychoeducational, Psychosocial, Randomized controlled trial, Online, Support
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project SOAR Awakenings armBehavioural
Four Project SOAR Awakenings sessions will be conducted electronically (Zoom) by experts in a group format (12-18 participants/group) with Black American women diagnosed with breast cancer. The Strong Black Woman concept and other culturally curated topics will be discussed as they apply to group members' experience of breast cancer. All women in the study will receive a care box with resources for Black American women diagnosed with breast cancer.
Project SOAR comparison groupBehavioural
Black American women diagnosed with breast cancer in this arm will receive a care box with resources for Black American women diagnosed with breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Project SOAR Comparison Group | Other | Black American women diagnosed with breast cancer in this arm will receive a care box with resources for Black American women diagnosed with breast cancer. Receives: Behavioral: Project SOAR comparison group |
| Project SOAR Awakenings intervention | Experimental | Four Project SOAR Awakenings sessions will be conducted electronically (Zoom) by experts in a group format (12-18 participants/group) with Black American women diagnosed with breast cancer. The Strong Black Woman concept and other culturally curated topics will be discussed as they apply to group members' experience of breast cancer. All women in the study will receive a care box with resources for Black American women diagnosed with breast cancer. Receives: Behavioral: Project SOAR Awakenings arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms - Center for Epidemiologic Studies-Depression scale
Validated self-report measure of depressive symptoms; range = 0-60; higher scores = greater depressive symptoms
Measured: Baseline, 1 month post-baseline, 4 months post-baseline
Fatigue - PROMIS Fatigue Short Form 7a; range = 7 - 35; higher scores indicate higher fatigue
A validated self-report measure of fatigue
Measured: Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcomes (1)
Well-being-World Health Organization-Five Well-Being Index; range = 0 - 25; high scores indicate higher well-being
A validated self-report measure of well-being
Measured: Baseline, 1 month post-baseline, 4 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start25 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 University of California, Los AngelesThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Annette L Stanton, University of California, Los Angeles
- Investigators
- Annette L Stanton, PhD, Principal investigator, University of California, Los AngelesTammie Denyse, MDiv Dr(Hon), Principal investigator, Carrie's TOUCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208084
- Sponsor's protocol ID
- BCRF-24-153
- Status last verified
- Aug 2025
- First submitted
- 3 Sep 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared once the trial is complete and major publications have been accepted.
Publications
Owoyemi P, Denyse T, Pageot YK, Martin KJ, DeLuz KD, Kim JHJ, Stanton AL. "You [God] Gotta Go Through It With Me": Black Women Navigating Spirituality During the Breast Cancer Journey. Psychooncology. 2025 Jan;34(1):e70085. doi: 10.1002/pon.70085.
PubMed 39853607Denyse T, Martin KJ, Kim JHJ, Pageot YK, Owoyemi P, DeLuz KD, Stanton AL. "No Complaining, No Crying": A Qualitative Study of the Strong Black Woman Schema in the Breast Cancer Context. Ann Behav Med. 2023 Aug 21;57(9):733-742. doi: 10.1093/abm/kaad029.
PubMed 37318273Martin KJ, Denyse T, Pageot YK, Kim JHJ, Owoyemi P, DeLuz KD, Stanton AL. "I'm Fighting for My Life": Exploring Interactions Between Black Women with Breast Cancer and Healthcare Providers. Qual Health Res. 2023 Jul;33(8-9):753-764. doi: 10.1177/10497323231168581. Epub 2023 May 22.
PubMed 37212719Denyse T, Martin KJ, Stanton AL. The Ubuntu Approach in Project SOAR (Speaking Our African American Realities): Building a robust community-academic partnership and culturally curated focus groups. Soc Sci Med. 2022 Dec;314:115452. doi: 10.1016/j.socscimed.2022.115452. Epub 2022 Oct 12.
PubMed 36274454
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project SOAR Awakenings: Randomized Controlled Trial for Black American Women Diagnosed With Breast Cancer
- ClinicalTrials.gov ID
- NCT07208084
- Acronym / sponsor ID
- BCRF-24-153
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, African American women, Psychoeducational, Psychosocial, Randomized controlled trial, Online, Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Oct 2025 (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 goal of this clinical trial is to test an approach to promote well-being in Black American women diagnosed with breast cancer. The main questions it aims to answer are:
- Can the Project SOAR (Speaking Our African American Realities) Awakenings online intervention improve depressive symptoms in Black American women diagnosed with breast cancer?
- Can the Project SOAR (Speaking Our African American Realities) Awakenings intervention improve fatigue in Black American women diagnosed with breast cancer?
- Can the Project SOAR (Speaking Our African American Realities) Awakenings intervention improve well-being in Black American women diagnosed with breast cancer? Researchers will compare the Awakenings online intervention to a comparison condition, to see if women in the Awakenings group improve on depressive symptoms, fatigue, and well-being more than women in the comparison group. Women in the comparison condition will receive materials by mail to use on their own.
Participants will:
- be randomized (selected by chance) to take part in four Project SOAR Gatherings, which are small group, 90-minute to two-hour online discussions with other Black American women diagnosed with breast cancer and are designed to promote well-being OR to a comparison group. Rev. Dr.(Hon) Tammie Denyse, a 20-year breast cancer survivor and patient advocate, will lead the Gatherings, along with other experts.
- devote about eight hours for women in the Project SOAR Gatherings discussions and two hours for women in the comparison group.
- complete online questionnaires at the beginning of the study and one month and three months later.
- receive a box of resources (e.g., book, cup, blanket, journal) designed to promote well-being.
Detailed description
Recruitment of participants for the Project SOAR Awakenings trial will be conducted via the website and other social media platforms of Carrie's TOUCH (https://carriestouch.org), a nonprofit organization located in Sacramento California for Black American women diagnosed with breast cancer. The president of Carrie's TOUCH is Rev. Dr.(Hon) Tammie Denyse, the Project SOAR (Speaking Our African American Realities) Awakenings co-Principal Investigator. Recruitment also will involve announcements and a flyer to parishioner rosters of the fifth district of African Methodist Episcopal (AME) churches, which comprises 15 states and with which Rev Dr.(Hon) Denyse is affiliated.
Announcements will direct women to an email and phone number to contact if they are interested in taking part in the Project SOAR Awakenings trial. When a potential participant expresses interest in the trial via email/phone, research staff will contact her to describe the trial, summarize elements of informed consent, confirm eligibility, answer any questions, and transmit the electronic baseline questionnaire to collect demographic data and reliable and valid measures of outcome variables (i.e., depressive symptoms, fatigue, well-being) and mediators (i.e., self-compassion, cancer-related coping through emotional expression, cancer-related avoidance-oriented coping). All elements of informed consent are described at the beginning of the electronic baseline questionnaire, and contact information is provided for research staff, principal investigators, and the Institutional Review Board. At the end of the description, participants are asked to click to proceed to the baseline questionnaire if they would like to take part in the study.
Upon the completion of the baseline questionnaires, women will be randomized 1:1 via an electronic platform to the Awakenings intervention or the enhanced treatment as usual (ETAU) condition. All participants then will be mailed resources constructed to promote caring for the self, including a book (Homecoming, 2022, Bryant), an article on the Strong Black Woman schema (Denyse … Stanton, 2023), a Project SOAR personal journal, a Project SOAR cup, a Rest Deck (Rest Is Resistance, 2022, Hersey), and a Project SOAR blanket. All participants also will be compensated $100 in a gift card (e.g., Target, Amazon) for their time at the three-month assessment point.
The date and time of the first intervention session will be emailed to participants randomized to the Project SOAR Awakenings intervention, with reminder phone calls. The four Project SOAR Awakenings sessions will be conducted electronically (Zoom) in group format (10-18 participants/group) by Rev. Dr.(Hon) Denyse and another interventionist, Dr. Thea Hairston, who also is expert in psychosocial interventions with Black American women, as assisted by a doctoral candidate research staff. Leaders and participants all will identify as Black American women. One session will be conducted each week over four weeks; each session will be approximately two hours long, for a total of eight hours. Women who miss any session will be encouraged to listen to the audio-recorded session via Zoom.
With encouragement of participants to read the article on the Strong Black Woman schema prior to the session, the first session, led by Rev. Dr.(Hon) Tammie Denyse, focuses on discussing the facets of the Strong Black Woman schema (i.e., suppress emotions related to cancer, prioritize caring for others over caring for the self, resist support from other people, present an image of strength, strive to achieve with insufficient resources) and challenging the harmful facets of the schema to promote self-compassion. The session will be based on the Gathering format used in the researchers' qualitative Project SOAR research, revised for therapeutic intent. With encouragement of participants to read two chapters of the book Homecoming prior to the session, the second session also will be led by Rev. Dr.(Hon) Tammie Denyse. The session will offer foundational psychoeducation and interactional exercises on managing traumatic and stressful experiences, drawing from the book Homecoming (Bryant, 2023). The third session will be led by Dr. Thea Hairston (beloveholistic.com). Dr. Hairston employs mindful movement exercises to promote self-compassion in Black American women. Conducted by Rev. Dr.(Hon) Denyse, the fourth session will summarize and reinforce the themes of prior sessions, including making an action plan for continuing to challenge the facets of the Strong Black Woman schema and enacting self-compassion.
Intervention sessions will be audio-recorded so that participants who miss sessions can listen to them via a password-protected link; the audio-recordings will be destroyed once the study is complete. There will be no paper study materials.
Immediately after the fourth session (and at the same time for ETAU participants), participants will be sent a link to complete measures of mediators and outcomes, with reminder emails/calls as needed to promote complete data collection. Measures again will be administered electronically three months after the final intervention session, with reminder emails/calls as needed. It is estimated that each of the three assessments will require no more than 45 minutes to complete, for a potential total of 135 minutes.
All data will be collected electronically over a secure platform. To minimize risks to confidentiality, all collected data will be coded by participant number. The key to this code will be kept in a password-protected and encrypted file on a HIPAA-compliant Box account hosted by UCLA, separate from all questionnaire data. The key will be accessible only to key study personnel, and no identifying information will be shared with researchers not directly involved in the study. At the end of the study, the key will be destroyed.
Collection of names and addresses of participants is necessary in order to send the study resources (e.g., books, journal) by mail. The electronic file containing names and addresses and linking those to participant numbers will be stored separately from the rest of the data, to be accessed only by study personnel.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project SOAR Comparison Group | Other | Behavioral: Project SOAR comparison groupBlack American women diagnosed with breast cancer in this arm will receive a care box with resources for Black American women diagnosed with breast cancer. |
| Project SOAR Awakenings intervention | Experimental | Behavioral: Project SOAR Awakenings armFour Project SOAR Awakenings sessions will be conducted electronically (Zoom) by experts in a group format (12-18 participants/group) with Black American women diagnosed with breast cancer. The Strong Black Woman concept and other culturally curated topics will be discussed as they apply to group members' experience of breast cancer. All women in the study will receive a care box with resources for Black American women diagnosed with breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- identifying as a woman at least 18 years of age (not limited to cisgender Black American women);
- identifying as Black (African) American;
- diagnosed with breast cancer of any stage and any diagnosis duration;
- able to speak and read English;
- residing in the United States;
Key exclusion criteria (4 listed)
- men diagnosed with breast cancer,
- non-English speaker
- nonresident of the United States
- no internet access
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 |
|---|---|---|
| Project SOAR Awakenings armFour Project SOAR Awakenings sessions will be conducted electronically (Zoom) by experts in a group format (12-18 participants/group) with Black American women diagnosed with breast cancer. The Strong Black Woman concept and other culturally curated topics will be discussed as they apply to group members' experience of breast cancer. All women in the study will receive a care box with resources for Black American women diagnosed with breast cancer. | Behavioural | Project SOAR Awakenings intervention |
| Project SOAR comparison groupBlack American women diagnosed with breast cancer in this arm will receive a care box with resources for Black American women diagnosed with breast cancer. | Behavioural | Project SOAR Comparison Group |
Primary outcome
Depressive symptoms - Center for Epidemiologic Studies-Depression scale
Time frame: Baseline, 1 month post-baseline, 4 months post-baseline
Validated self-report measure of depressive symptoms; range = 0-60; higher scores = greater depressive symptoms
Fatigue - PROMIS Fatigue Short Form 7a; range = 7 - 35; higher scores indicate higher fatigue
Time frame: Baseline, 1 month post-baseline, 4 months post-baseline
A validated self-report measure of fatigue
1 secondary outcome
Well-being-World Health Organization-Five Well-Being Index; range = 0 - 25; high scores indicate higher well-being
Time frame: Baseline, 1 month post-baseline, 4 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 39853607Owoyemi P, Denyse T, Pageot YK, Martin KJ, DeLuz KD, Kim JHJ, Stanton AL. "You [God] Gotta Go Through It With Me": Black Women Navigating Spirituality During the Breast Cancer Journey. Psychooncology. 2025 Jan;34(1):e70085. doi: 10.1002/pon.70085.
- Background: PubMed 37318273Denyse T, Martin KJ, Kim JHJ, Pageot YK, Owoyemi P, DeLuz KD, Stanton AL. "No Complaining, No Crying": A Qualitative Study of the Strong Black Woman Schema in the Breast Cancer Context. Ann Behav Med. 2023 Aug 21;57(9):733-742. doi: 10.1093/abm/kaad029.
- Background: PubMed 37212719Martin KJ, Denyse T, Pageot YK, Kim JHJ, Owoyemi P, DeLuz KD, Stanton AL. "I'm Fighting for My Life": Exploring Interactions Between Black Women with Breast Cancer and Healthcare Providers. Qual Health Res. 2023 Jul;33(8-9):753-764. doi: 10.1177/10497323231168581. Epub 2023 May 22.
- Background: PubMed 36274454Denyse T, Martin KJ, Stanton AL. The Ubuntu Approach in Project SOAR (Speaking Our African American Realities): Building a robust community-academic partnership and culturally curated focus groups. Soc Sci Med. 2022 Dec;314:115452. doi: 10.1016/j.socscimed.2022.115452. Epub 2022 Oct 12.
- Individual participant dataSharing planned: Yes. De-identified data will be shared once the trial is complete and major publications have been accepted.
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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.
Annette L Stanton, PhD principal investigator
University of California, Los Angeles
Tammie Denyse, MDiv Dr(Hon) principal investigator
Carrie's TOUCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project SOAR Awakenings arm and Project SOAR comparison group in people with Breast Cancer, run by University of California, Los Angeles 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 4 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Jorge, MA (323-425-9379, projectsoar2018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms - Center for Epidemiologic Studies-Depression scale (time frame: Baseline, 1 month post-baseline, 4 months post-baseline). 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 NCT07208084, which also lists 4 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 26 Jan 2026.