Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention

NCT06168825 | Completed

• 1 other identifier: U23-06-5102
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to learn if the Mind Over Matter (MOM) Intervention, a 5-week group program, can help Black and African American women deal with the fears, worries and sadness that often accompany cancer diagnosis and treatment. The main question this study aims to answer is:

• Whether the MOM Intervention is feasible and acceptable among Black and African American women. We would also like to find out if:
• The MOM Intervention decreases anxiety, depression and physical symptom severity for Black and African American women.
• The MOM Intervention is culturally and linguistically appropriate, and identify barriers, strengths, and areas of improvement. Participants will:
• Attend a Pre-Program Orientation
• Attend 5 weekly MOM Sessions
• Complete 2 questionnaires (one will be given before the first MOM Session begins, and the other will be given after the last MOM Session) Participants also have the choice to attend an optional Focus Group, which will be offered after the last MOM Session. Please note, this entire Intervention will be offered online. There will be no in-person sessions or visits.

Conditions

Cancer; Breast Cancer; Brain Cancer; Central Nervous System Cancer; Colorectal Cancer; Esophageal Cancer; Gynecologic Cancer; Head and Neck Cancer; Gastrointestinal Cancer; Genitourinary Cancer; Melanoma; Blood Cancer; Lung Cancer; Acceptance and Commitment Therapy; Mind-Body Therapies; Psychosocial Intervention

Outcome Measures

Primary Outcomes (2)

• Feasibility of MOM intervention

  The MOM intervention will be considered feasible if 60% of the participants registered to attend the intervention (and complete the consent process) complete 4 out of 5 sessions of the intervention

  Baseline to 7 weeks

• Acceptability of the MOM intervention

  Telehealth Usability Questionnaire (TUQ) which will be used to measure the primary endpoint of acceptability, the TUQ response set ranges from 1 (disagree) to 7 (agree). Anchoring the score of 4 as neither disagree or agree and 5, 6, and 7 are some levels of agreement. The MOM intervention will be considered acceptable if the average usability score, as measured by the TUQ, are equal to or above 4.5.

  Baseline (pretest) and 7 weeks (posttest)

Secondary Outcomes (5)

• Change in Depression from baseline

  Baseline and 7 weeks

• Change in Anxiety from baseline

  Baseline and 7 weeks

• Change in symptom severity from baseline

  Baseline and 7 weeks

• Number of participants who reported MOM intervention as Cultural appropriate

  Baseline and 7 weeks

• Number of participants who reported MOM intervention as linguistically appropriate

  Baseline and 7 weeks

Study Arms (1)

Black and African American Women diagnosed with Cancer

Participants who have completed primary treatment (completed chemotherapy and/or radiation and/or surgery) are eligible to participate in the study

Other: Mind Over Matter (MOM)

Interventions

Mind Over Matter (MOM) OTHER

Each participant's involvement in the study will include: * Attending a Pre-Program Orientation which will be held a week before the first MOM Session. * Completing 5 weekly sessions of MOM * Completing 2 surveys; one will be given before the start of the intervention (a pre-test) and the other will be given after the last MOM Session (a post-test) Participants will also have the option to participate in an optional Focus Group session which will occur a week after the last MOM Session ends Participants will spend about 6 weeks in this study. If they decide to participate in the optional session, they will spend about 7 weeks in this study. Please note, this entire Intervention will be offered online. There will be no in-person sessions or visits.

Black and African American Women diagnosed with Cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants who self-identify as female or a woman are eligible for the Intervention
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Howard University Cancer Center, a cancer center that treats patients that are primarily of African American descent in the Washington, DC metropolitan area, Inova Schar Cancer Institute, a state-of-the-art cancer center in the Washington, DC metropolitan area, and Inova Life With Cancer, a program of the Inova Schar Cancer Institute, which offers a variety of programs and services for cancer patients, survivors and their family members. The outreach for participants will be supported by collaborations and relationships with organizations and institutions that support Black and African American women managing cancer such as the Tigerlily Foundation and the VCU Massey Cancer Center. Potential Participants may also self-refer themselves to this study by contacting the study team.

You may qualify if:

• Self-identify as Black or African American
• Self-identify as female or a woman
• Having received a diagnosis and treatment for any type of cancer
• Having completed primary treatment (completed chemotherapy and/or radiation and/or surgery)
• ≥18 years of age
• Able to understand and provide valid informed consent prior to any study procedure
• Access to the internet and email
• Being able to speak and understand written and spoken English

You may not qualify if:

• Self-identify as other than Black or African American
• Does not Self-identify as a female or a woman
• Does not have a diagnosis of cancer
• Has not completed primary treatment
• Under the age of 18
• Not able to understand and provide valid informed consent
• Does not have access to the internet or email
• Not being able to speak, read and understand English

Sponsors & Collaborators

• Inova Health Care Services: lead
• Howard University: collaborator
• University of Louisville: collaborator
• University of Houston: collaborator
• VCU Massey Cancer Center: collaborator
• Tigerlily Foundation: collaborator

Study Sites (2)

Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

Inova Life With Cancer

Fairfax, Virginia, 22031, United States

Location

Related Publications (1)

• Ferretti M, Lowery Walker K, Bires J, BrintzenhofeSzoc K. Building coping skills to relieve distress and physical symptoms: Findings from a quality improvement project of a five-week group psychoeducational program for cancer patients. J Psychosoc Oncol. 2024;42(2):256-270. doi: 10.1080/07347332.2023.2238263. Epub 2023 Jul 24.

  PMID: 37486181 BACKGROUND

Related Links

• Study Website

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Head and Neck Neoplasms; Gastrointestinal Neoplasms; Urogenital Neoplasms; Melanoma; Hematologic Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Esophageal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michelle Ferretti, MSW, LCSW, OSW-C

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: January 17, 2024
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

US (2)