AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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.

Alexandra Jorge, MA contact

323-425-9379

projectsoar2018@gmail.com

Annette Stanton, PhD contact

310-825-3105

astanton@ucla.edu

United States1 site, 1 recruiting
  • UCLA

    Los Angeles, California, 90095-1563

    Annette L Stanton, PhD, 310-825-3105, astanton@ucla.edu

    Recruiting

Other trials in United States

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 groups in NCT07208084
Study groupRoleWhat they receive
Project SOAR Comparison GroupOtherBlack 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 interventionExperimentalFour 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.

  1. 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

  2. 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)
  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.

  1. First posted6 Oct 2025
  2. Study start25 Jul 2025
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

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)
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 39853607
  • Denyse 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 37318273
  • Martin 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 37212719
  • Denyse 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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in