An observational study in Cancer, Breast Cancer and Brain Cancer, sponsored by Inova Health Care Services. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Inova Health Care Services · Observational
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:
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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's enrollment of 40 is below the median of 197 across 176 observational studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Inova Health Care Services is the lead sponsor of 84 studies on the registry; 20 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
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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.
Exclusion Criteria:
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)
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.
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
Time frame: 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.
Time frame: Baseline (pretest) and 7 weeks (posttest)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline and 7 weeks
Plan to share: Undecided
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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