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

Project SOAR Awakenings: Randomized Controlled Trial for Black American Women Diagnosed With Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Questionnaires, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "One session will be conducted each week over four weeks; each session will be approximately two hours long, for a total of eight hours."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Project SOAR Awakenings, an online group program, can ease depression symptoms and tiredness and improve well-being in Black American women with breast cancer. Participants are placed by chance into either four online group discussions or a group that gets materials by mail to use on their own.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Identify as a woman and be at least 18 years old; transgender women may also join.
  • Identify as Black (African) American.
  • Have breast cancer at any stage, no matter when it was diagnosed.
  • Be able to speak and read English.
  • Live in the United States.
  • Have access to the internet and Zoom.

Who can't join

  • Men with breast cancer.
  • People who do not speak English.
  • People who do not live in the United States.
  • People without internet access.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA