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

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.

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.

Arms & interventions

• BehavioralProject 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.

• BehavioralProject 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.

Outcome measures

Eligibility criteria