NCT07208084 · University of California, Los Angeles
Project SOAR (Speaking Our African American Realities) Awakenings for Black American Women Diagnosed With Breast Cancer
What this study is about
The goal of this clinical trial is to test an approach to promote well-being in Black American women diagnosed with breast cancer.
View original scientific description
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.
Interventions
BEHAVIORAL
Project SOAR Awakenings arm
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.
BEHAVIORAL
Project SOAR comparison group
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- men diagnosed with breast cancer,
- non-English speaker
- nonresident of the United States
- no internet access
Where
- Los Angeles, California
Collaborators
Breast Cancer Research Foundation
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 26, 2026 · Source of record for eligibility and locations