Clinical trial NCT06168825: Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention
Official title: Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: Howard University
name: University of Louisville
name: University of Houston
name: VCU Massey Cancer Center
name: Tigerlily Foundation
First posted: 2023-12-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Up to half of patients affected by cancer will experience psychosocial distress. Emotional and physical symptoms are two common facets of psychosocial distress. For those managing cancer, unmet psychosocial needs can lead to lower quality of life, poorer adherence to medical treatments, and increased healthcare costs. In a recent study investigating White, African American, Hispanic, Asian and Pacific Islander patients, it was found that African American patients were significantly more likely to experience clinical levels of psychosocial distress.

Inova Life with Cancer® has developed Mind Over Matter (MOM), a group psychosocial program designed to teach emotional coping skills to anyone affected by cancer. MOM consists of five, 1.5-hour sessions. The foundational theories of MOM are Cognitive Behavioral Therapy (CBT), Acceptance \& Commitment Therapy (ACT), and the physiology of the stress response. Each session introduces a core cognitive concept and a different relaxation exercise. These sessions are structured and educational, with a focus on building skills, and are not a therapy or a support group. At the end of each session, participants are given exercises to practice the core cognitive concept and the relaxation at home. Participants are also offered optional reading to support the core cognitive concept. Practice outside of the class is vital. Thus, it is important to allow enough time to process and review the home practice exercises each week - this is the core of the program.

A retrospective secondary data analysis of the MOM intervention found a significant decrease in anxiety, depression, physical symptom severity, and physical symptom interference from pre- to post-test.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of MOM intervention
timeFrame: Baseline to 7 weeks
measure: Acceptability of the MOM intervention
timeFrame: Baseline (pretest) and 7 weeks (posttest)
Secondary outcomes:
measure: Change in Depression from baseline
timeFrame: Baseline and 7 weeks
measure: Change in Anxiety from baseline
timeFrame: Baseline and 7 weeks
measure: Change in symptom severity from baseline
timeFrame: Baseline and 7 weeks
measure: Number of participants who reported MOM intervention as Cultural appropriate
timeFrame: Baseline and 7 weeks
measure: Number of participants who reported MOM intervention as linguistically appropriate
timeFrame: Baseline and 7 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University Cancer Center
state: District of Columbia
city: Fairfax
country: United States
facility: Inova Life With Cancer
state: Virginia
Study officials:
affiliation: Inova Health Care Services
name: Michelle Ferretti, MSW, LCSW, OSW-C
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.