Mind Over Matter for Black and African American Women: A Single Arm Trial Examining Feasibility and Acceptability of a Supportive Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of MOM intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility of MOM intervention
时间窗: 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
时间窗: 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.
次要结局
- Change in Anxiety from baseline(Baseline and 7 weeks)
- Number of participants who reported MOM intervention as Cultural appropriate(Baseline and 7 weeks)
- Change in symptom severity from baseline(Baseline and 7 weeks)
- Number of participants who reported MOM intervention as linguistically appropriate(Baseline and 7 weeks)
- Change in Depression from baseline(Baseline and 7 weeks)