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| Name | Class |
|---|---|
| Howard University | OTHER |
| University of Louisville | OTHER |
| University of Houston | OTHER |
| VCU Massey Cancer Center |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind Over Matter (MOM) | Other | Each participant's involvement in the study will include:
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. |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Participants who self-identify as female or a woman are eligible for the Intervention
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Ferretti, MSW, LCSW, OSW-C | Inova Health Care Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Howard University Cancer Center | Washington D.C. | District of Columbia | 20060 | United States | ||
| Inova Life With Cancer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37486181 | Background | 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. | |
| 42311030 |
| Label | URL |
|---|---|
| Study Website | View source |
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| UNKNOWN |
| Tigerlily Foundation | UNKNOWN |
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|
| 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 |
| Fairfax |
| Virginia |
| 22031 |
| United States |
| Ferretti M, BrinzenhofeSzoc K, Taylor T, Grant T, Varikkodan S, Sedaghatshoar S, O'Neil K, Raja N, Miller MF, Acquati C, Bires J. Feasibility and Acceptability of a 5-Week Group Coping Skills Program Among Black and African American Women With Cancer. Psychooncology. 2026 Jun;35(6):e70523. doi: 10.1002/pon.70523. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D014565 | Urogenital Neoplasms |
| D008545 | Melanoma |
| D019337 | Hematologic Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004935 | Esophageal Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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