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

April 22, 2024 updated by: Inova Health Care Services

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 7 weeks
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.
Baseline (pretest) and 7 weeks (posttest)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression from baseline
Time Frame: Baseline and 7 weeks
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
Time Frame: Baseline and 7 weeks
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
Time Frame: Baseline and 7 weeks
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
Time Frame: Baseline and 7 weeks
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
Time Frame: Baseline and 7 weeks
linguistic appropriateness of the MOM intervention will be determined by participants' self-reported accounts
Baseline and 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Collaborators

University of Houston
University of Louisville
Howard University
Tigerlily Foundation
VCU Massey Cancer Center

Investigators

  • Principal Investigator: Michelle Ferretti, MSW, LCSW, OSW-C, Inova Health Care Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U23-06-5102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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