Effectiveness of Mindfulness-Based Intervention on Patient Reported Outcomes of Black Adult Cancer Survivors: A Community Faith-Based Mindfulness Ministry (ComFaMM) Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Spiritual well-being
研究概览
简要总结
This clinical trial evaluates the impact of a Mindfulness-Based Stress Reduction (MBSR) program adjusted to include Christian principles on well-being in Black adult cancer survivors. Cancer survivors face a unique set of challenges that includes not only physical but also mental and spiritual well-being. Concerns related to both diagnosis and treatment profoundly impact the quality of life of Black cancer survivors. Mindfulness-based interventions (MBIs) have been shown to be effective in improving psychological resilience, reducing anxiety, and enhancing the quality of life among cancer survivors. However, there is little research focusing on these interventions among Black adult cancer survivors. Research has shown that interventions that include cultural experiences, such as the role of religion, spirituality and faith, are more effective in maintaining psychological well-being in Black men. A MBSR program adjusted to include Christian principles may improve the well-being in Black adult cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. Develop a culturally adapted Mindfulness-Based Stress Reduction (MBSR) intervention. (Phase 0) II. Pilot test the MBSR intervention to assess its feasibility, acceptability, and preliminary efficacy among a small group of participants. (Phase 0) III. To implement an overnight silent mindfulness retreat intervention that incorporates faith based cultural adaptations tailored for Black participants. (Phase I)
OUTLINE:
PHASE 0:
INTERVENTION DEVELOPMENT: Participants attend a focus group or a one-on-one interview over up to 60 minutes to gather insights of the cultural needs of Black adult cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PHASE 0 DEVELOPMENT: Adults aged 18 or older
- •PHASE 0 DEVELOPMENT: Ability to speak, read and understand English
- •PHASE 0 DEVELOPMENT: Individuals personally affected by cancer, either through their own diagnosis or that of a loved one
- •PHASE 0 DEVELOPMENT: Self-identifies as Black or African American
- •PHASE 0 DEVELOPMENT: Membership or affiliation with a faith-based organization
- •PHASE 0 PILOT TESTING: Adults aged 18 or older
- •PHASE 0 PILOT TESTING: History of a cancer diagnosis
- •PHASE 0 PILOT TESTING: Meets National Cancer Institute (NCI) cancer survivor definition (a person is a survivor from the time of diagnosis until the end of life)
- •PHASE 0 PILOT TESTING: Ability to physically attend live MBI and complete web-based surveys and assessments
- •PHASE 0 PILOT TESTING: Ability to speak, read and understand English
- •PHASE 1: Adults aged 18 or older
- •PHASE 1: History of a cancer diagnosis
- •PHASE 1: Meets NCI cancer survivor definition (a person is a survivor from the time of diagnosis until the end of life)
- •PHASE 1: Ability to physically attend live MBI and complete web-based surveys and assessments
- •PHASE 1: Ability to speak, read and understand English
- •PHASE 2: Adults aged 18 or older
- •PHASE 2: History of a cancer diagnosis
- •PHASE 2: Meets NCI Cancer Survivor definition (a person is a survivor from the time of diagnosis until the end of life)
- •PHASE 2: Ability to physically attend live MBI and complete web-based surveys and assessments
- •PHASE 2: Ability to speak, read and understand English
排除标准
- •PHASE 0 DEVELOPMENT: Does not meet the inclusion criteria
- •PHASE 0 DEVELOPMENT: Unable or unwilling to participate in the recorded sessions
- •PHASE 0 PILOT TESTING: Inability to attend and participate in MBI due to medical or psychological hardship
- •PHASE 0 PILOT TESTING: Inability to speak, read and understand English
- •PHASE 1: Inability to attend and participate in MBI due to medical or psychological hardship
- •PHASE 1: Inability to speak, read and understand English
- •PHASE 1: Participated in phase 0 of the study
- •PHASE 2: Inability to attend and participate in MBI due to medical or psychological hardship
- •PHASE 2: Inability to speak, read and understand English
- •PHASE 2: Participated in phase 0 or phase 1 of the study
研究组 & 干预措施
Phase 0 (intervention development, pilot testing)
INTERVENTION DEVELOPMENT: Participants may attend a focus group or a one-on-one interview over up to 60 minutes to gather insights of the cultural needs of Black adult cancer survivors.
PILOT TESTING: Patients participate in a group discussion with exercises and activities on study.
干预措施: Interview (Other)
Phase 0 (intervention development, pilot testing)
INTERVENTION DEVELOPMENT: Participants may attend a focus group or a one-on-one interview over up to 60 minutes to gather insights of the cultural needs of Black adult cancer survivors.
PILOT TESTING: Patients participate in a group discussion with exercises and activities on study.
干预措施: Questionnaire Administration (Other)
Phase 0 (intervention development, pilot testing)
INTERVENTION DEVELOPMENT: Participants may attend a focus group or a one-on-one interview over up to 60 minutes to gather insights of the cultural needs of Black adult cancer survivors.
PILOT TESTING: Patients participate in a group discussion with exercises and activities on study.
干预措施: Discussion (Other)
Phase 1 (MBSR)
Patients participate in an overnight silent mindfulness retreat intervention, over 31 hours, with faith-based cultural adaptation emphasizing resilience and cultural relevant spiritual framing. The retreat includes sessions on different types of meditation, working with thoughts and emotions, stress, mindfulness techniques and how to integrate them, positive mind states, resiliency and resources, including educational handouts.
干预措施: Questionnaire Administration (Other)
Phase 1 (MBSR)
Patients participate in an overnight silent mindfulness retreat intervention, over 31 hours, with faith-based cultural adaptation emphasizing resilience and cultural relevant spiritual framing. The retreat includes sessions on different types of meditation, working with thoughts and emotions, stress, mindfulness techniques and how to integrate them, positive mind states, resiliency and resources, including educational handouts.
干预措施: Educational Intervention (Other)
Phase 1 (MBSR)
Patients participate in an overnight silent mindfulness retreat intervention, over 31 hours, with faith-based cultural adaptation emphasizing resilience and cultural relevant spiritual framing. The retreat includes sessions on different types of meditation, working with thoughts and emotions, stress, mindfulness techniques and how to integrate them, positive mind states, resiliency and resources, including educational handouts.
干预措施: Mindfulness Relaxation (Behavioral)
结局指标
主要结局
Spiritual well-being
时间窗: Up to 3 months
Will be measured by the change in scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12). The FACIT-Sp-12a is a 12-item scale measuring spiritual well-being over the past 7 days. Responses are on a 5 point Likert-type scale (0=not at all; 1=a little bit, 2=somewhat; 3=quite a bit; 4=very much) with higher scores generally representing greater well-being
Spiritual well-being
时间窗: Pre-MBI, Post-MBI (immediately after MBI), 3 months, 6months
Will be measured by the change in scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12). The FACIT-Sp-12a is a 12-item scale measuring spiritual well-being over the past 7 days. Responses are on a 5 point Likert-type scale (0=not at all; 1=a little bit, 2=somewhat; 3=quite a bit; 4=very much) with higher scores generally representing greater well-being
次要结局
- Quality of life (QOL)(Up to 3 months)
- Level of resilience - CD-RISC(Up to 3 months)
- Level of resilience - RSA(Up to 3 months)
- Personal spirituality and closeness with God(Up to 3 months)
- Overall assessment of the MBI and perception of MBI value(3 months)
- Quality of life (QOL) (Phase 1)(Pre-MBI, Post-MBI, 3 months, 6months)
- Level of resilience - CD-RISC (Phase 1)(Pre-MBI, Post-MBI, 3 months, 6months)
- Level of resilience - RSA(Pre-MBI, Post-MBI, 3 months, 6months)
- Overall assessment of the MBI and perception of MBI value (Phase 1)(Post-MBI, 3 months, 6months)