Esophageal Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

44

Study ID:

NCT06168825

Recruitment Status:

Recruiting

Sponsor:

Inova Health Care Services

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There are 2 Locations for this study

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Howard University Cancer Center
Washington District of Columbia, 20060, United States More Info
Teletia Taylor, PhD
Principal Investigator
Inova Life With Cancer
Fairfax Virginia, 22031, United States More Info
Kelly O'Neil, MS
Contact
571-472-0233
[email protected]
Natasha Raja, MS
Contact
[email protected]
Michelle Ferretti, LCSW, OSW-C
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

44

Study ID:

NCT06168825

Recruitment Status:

Recruiting

Sponsor:


Inova Health Care Services

How clear is this clinincal trial information?

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