Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Esophageal Neoplasms

Breast Neoplasms

Melanoma

Brain Neoplasms

Head and Neck Neoplasms

Lung Neoplasms

Hematologic Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urogenital Neoplasms

Gastrointestinal Diseases

Brain Diseases

Central Nervous System Diseases

Hematologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Esophageal Cancer

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

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.

Mind Over Matter (MOM)

Michelle Ferretti, MSW, LCSW, OSW-C

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.

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.

Participants who self-identify as female or a woman are eligible for the Intervention

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

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.

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.

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.

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.

Cultural appropriateness of the MOM intervention will be determined by participants' self-reported accounts

linguistic appropriateness of the MOM intervention will be determined by participants' self-reported accounts

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention	NCT06168825	Cancer Breast Cancer Brain Cancer Central Nervous... Colorectal Canc... Esophageal Canc... Gynecologic Can... Head and Neck C... Gastrointestina... Genitourinary C... Melanoma Blood Cancer Lung Cancer Acceptance and ... Mind-Body Thera... Psychosocial In...	Mind Over Matte...	18 Years -	Inova Health Care Services
Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention	NCT06168825	Cancer Breast Cancer Brain Cancer Central Nervous... Colorectal Canc... Esophageal Canc... Gynecologic Can... Head and Neck C... Gastrointestina... Genitourinary C... Melanoma Blood Cancer Lung Cancer Acceptance and ... Mind-Body Thera... Psychosocial In...	Mind Over Matte...	18 Years -	Inova Health Care Services

Spots Global Cancer Trial Database for mind over matter (mom)