Project SOAR (Speaking Our African American Realities) Awakenings for Black American Women Diagnosed With Breast Cancer

NCT07208084 | Recruiting

• 1 other identifier: BCRF-24-153
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Depressive symptoms - Center for Epidemiologic Studies-Depression scale

  Validated self-report measure of depressive symptoms; range = 0-60; higher scores = greater depressive symptoms

  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

  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

  Baseline, 1 month post-baseline, 4 months post-baseline

Other Outcomes (5)

• Self-compassion - Neff Self-Kindness subscale; range = 5 - 25; higher scores indicate higher self-kindness

  Baseline, 1 month post-baseline, 4 months post-baseline

• Cancer-related coping through emotional expression - Emotional Approach Coping Emotional Expression subscale; range mean = 1 - 4; higher scores indicate higher coping with cancer through emotional expression;

  Baseline, 1 month post-baseline, 4 months post-baseline

• Cancer-related coping through avoidance - COPE Avoidance-oriented coping subscales; range mean = 1-4; higher scores indicate higher coping with cancer through avoidance

  Baseline, 1 month post-baseline, 4 months post-baseline

Study Arms (2)

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.

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.

Behavioral: Project SOAR Awakenings arm

Interventions

Project SOAR Awakenings arm BEHAVIORAL

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 Awakenings intervention

Project SOAR comparison group BEHAVIORAL

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.

Project SOAR Comparison Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• men diagnosed with breast cancer,
• non-English speaker
• nonresident of the United States
• no internet access

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095-1563, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 39853607 BACKGROUND

• 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.

  PMID: 37318273 BACKGROUND

• 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.

  PMID: 37212719 BACKGROUND

• 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.

  PMID: 36274454 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Annette L Stanton, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Tammie Denyse, MDiv Dr(Hon)

  Carrie's TOUCH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Jorge, MA

CONTACT

323-425-9379; projectsoar2018@gmail.com

Annette Stanton, PhD

CONTACT

310-825-3105; astanton@ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: October 6, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Anticipated 2026-2030.
• Access Criteria: To be determined.

Locations

US (1)