Recruiting

Project SOAR

Sponsor:

UCLA

Code:

NCT07208084

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Project SOAR Awakenings arm

Project SOAR comparison group

Study Details

Brief 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 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.

Conditions

Breast Cancer

Study ID

NCT07208084

Start date

Jul 25, 2025

Status verified date

Aug, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: 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.

experimental: Project SOAR Awakenings intervention

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.

Interventions

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.

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 measure

  • Depressive symptoms - Center for Epidemiologic Studies-Depression scale [ Time Frame: Baseline, 1 month post-baseline, 4 months post-baseline ]
  • 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 ]

Central Contacts and Locations

Central contacts

Alexandra Jorge, MA

323-425-9379projectsoar2018@gmail.com

Annette Stanton, PhD

310-825-3105astanton@ucla.edu

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095-1563

Contacts

Annette L Stanton, PhD

310-825-3105astanton@ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jan 26, 2026

Last verified

Aug, 2025

Keywords

  • Breast Cancer
  • African American women
  • Psychoeducational
  • Psychosocial
  • Randomized controlled trial
  • Online
  • Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-01-26.