CancerMOMNCT06168825
Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention
An observational study of Cancer and Breast Cancer, run by Inova Health Care Services at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Breast Cancer, Brain Cancer
- What is being tested?
- Mind Over Matter (MOM)
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jan 2024to 4 Jun 2024
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Inova Life With Cancer
Fairfax, Virginia, 22031
Howard University Cancer Center
Washington D.C., District of Columbia, 20060
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Cancer, Breast Cancer, Brain Cancer, Central Nervous System Cancer, Colorectal Cancer, Esophageal Cancer
- Being tested
- Mind Over Matter (MOM)
- Medical subject headings
- Neoplasms, Breast Neoplasms, Brain Neoplasms, Central Nervous System Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind Over Matter (MOM)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Mind Over Matter (MOM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline (pretest) and 7 weeks (posttest)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start17 Jan 2024
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- Howard University, University of Louisville, University of Houston, VCU Massey Cancer Center, Tigerlily Foundation
- Responsible party
- Sponsor
- Investigators
- Michelle Ferretti, MSW, LCSW, OSW-C, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168825
- Sponsor's protocol ID
- U23-06-5102
- Acronym
- MOM
- Status last verified
- Feb 2025
- First submitted
- 5 Dec 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37486181Ferretti 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.
PubMed 42311030
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention
- ClinicalTrials.gov ID
- NCT06168825
- Acronym / sponsor ID
- MOM / U23-06-5102
- Conditions
- Cancer, Breast Cancer, Brain Cancer, Central Nervous System Cancer, Colorectal Cancer, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- Howard University, University of Louisville, University of Houston, VCU Massey Cancer Center, Tigerlily Foundation
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Black and African American Women diagnosed with Cancer | – | Other: Mind Over Matter (MOM)Participants who have completed primary treatment (completed chemotherapy and/or radiation and/or surgery) are eligible to participate in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Black and African American Women diagnosed with Cancer |
Primary outcome
Feasibility of MOM intervention
Time frame: Baseline to 7 weeks
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
Acceptability of the MOM intervention
Time frame: Baseline (pretest) and 7 weeks (posttest)
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.
5 secondary outcomes
Change in Depression from baseline
Time frame: Baseline and 7 weeks
Change in Anxiety from baseline
Time frame: Baseline and 7 weeks
Change in symptom severity from baseline
Time frame: Baseline and 7 weeks
Number of participants who reported MOM intervention as Cultural appropriate
Time frame: Baseline and 7 weeks
Number of participants who reported MOM intervention as linguistically appropriate
Time frame: Baseline and 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 37486181Ferretti 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.
- Derived from this study: PubMed 42311030Ferretti 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.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Ferretti, MSW, LCSW, OSW-C principal investigator
Inova Health Care Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Breast Cancer, run by Inova Health Care Services at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of MOM intervention (time frame: Baseline to 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06168825, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.