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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Other: Mind Over Matter (MOM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Black and African American Women diagnosed with Cancer<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression from baseline | Patient Health Questionnaire-8 (PHQ-8) self-report 9-item Likert scale will be used to measure Depression. The first eight items are scored from 0 (not at all) to 4 (nearly every day) with scores ranging from 0 to 32. The last item asks about how difficult the depression is in terms of daily functioning, using a scale from 0 (not at all) to 3 (extremely). The higher the score, the higher the depression. Change in Depression will be considered significant if the mean PHQ-8 scores decrease from the pre- to post-test. | Baseline and 7 weeks | 
| Change in Anxiety from baseline | The Generalized Anxiety Disorder 7 (GAD-7) will be used to measure anxiety. For the first 7 items scores range from 0 (not at all) to 3 (nearly every day) with scores ranges from 0 to 21. Item 8 asks how difficult anxiety has been in terms of daily functioning. The range of scores is 0-21, with the higher score being higher levels of anxiety being reported. Change in Anxiety will be considered significant if the mean GAD-7 scores decrease from the pre- to post-test. | Baseline and 7 weeks | 
| Change in symptom severity from baseline | The MD Anderson Symptom Inventory (MDASI) will be used to measure physical symptom severity and interference with daily living. The MDASI is made up of two subscales, the first includes 13 physical symptoms and the second includes six interference items. The physical symptom severity items are rated on an 11-point scale (0 = not present to 10 = as bad as you can imagine) and the interference items are rated on an 11-point scale (0 = did not interfere to 10 = interfered completely). For both subscales, the higher the score the worse the severity and the level of interference. Change in Symptom severity will be considered significant if the mean MDASI scores decrease from the pre- to post-test. | Baseline and 7 weeks | 
| Number of participants who reported MOM intervention as Cultural appropriate | Cultural appropriateness of the MOM intervention will be determined by participants' self-reported accounts | Baseline and 7 weeks | 
| Number of participants who reported MOM intervention as linguistically appropriate | linguistic appropriateness of the MOM intervention will be determined by participants' self-reported accounts | Baseline and 7 weeks |