Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Identify the preferences of mCRC patients' partners for intervention content
研究概览
简要总结
The overall objective of this study is to develop a novel couple-based mindfulness intervention aimed at reducing distress in patients with metastatic colorectal cancer (mCRC) and their partners.
详细描述
The overall objective of this study is to develop a novel couple-based mindfulness intervention aimed at reducing distress in patients with metastatic colorectal cancer (mCRC) and their partners. The intervention is named "MIND-Together" (Mindfully Navigating Distress Together). MIND-Together will be the first mindfulness-based intervention designed to reduce mCRC couples' distress by targeting their unique psychosocial needs. The intervention is projected to be a 4-session intervention delivered by a trained therapist to individual couples facing mCRC (i.e., a patient and his/her intimate partner) via video-conference (e.g., Zoom).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Inclusion Criteria:
- •Provision to sign and date the consent form.
- •Stated willingness to comply with all study procedures and be available for the duration of the study.
- •Be aged > 18 years.
- •Fluent in English language
- •Be a person (i.e., patient) diagnosed with metastatic colorectal cancer (mCRC), a partner (e.g., spouse) of someone diagnosed with mCRC, or a clinician who treats patients diagnosed with mCRC.
- •Additional patient participant inclusion criteria:
- •Has a current diagnosis of metastatic (Stage IV, recurrent) colorectal cancer
- •Has an ECOG status <2 or otherwise deemed appropriate for study participation by a clinician
- •Is in a committed relationship with a romantic partner for >6 months
- •Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer)
- •Indicates a score >0 on the Distress Thermometer
- •Additional partner participant inclusion criteria:
- •Has been in a committed relationship >6 months with a patient who meets the above eligibility criteria
- •Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer)
- •Indicates a score >0 on the Distress Thermometer
- •Additional clinician participant inclusion criteria:
- •∙Is a physician or advanced practice clinician (e.g., oncologist, nurse practitioner, physician assistant, psychologist, mental health provider, etc.)
排除标准
- •∙Has a serious mental illness (e.g., psychotic disorder), cognitive impairment (e.g., dementia), or medical condition (e.g., significant impaired sight/hearing) that would compromise participation
研究组 & 干预措施
Metastatic Colorectal Cancer Patients
We anticipate enrolling up to a total of 18 patients who have been diagnosed with metastatic colorectal cancer; 12 patients will participate in the qualitative interview, and 6 patients will participate in the cognitive interview.
干预措施: Qualitative interview (Behavioral)
Metastatic Colorectal Cancer Patients Partners
We anticipate enrolling up to a total of 18 partners of patients who have been diagnosed with metastatic colorectal cancer; 12 partners will participate in the qualitative interview, and 6 paartners will participate in the cognitive interview.
干预措施: Qualitative interview (Behavioral)
Metastatic Colorectal Cancer Patients
We anticipate enrolling up to a total of 18 patients who have been diagnosed with metastatic colorectal cancer; 12 patients will participate in the qualitative interview, and 6 patients will participate in the cognitive interview.
干预措施: Cognitive Interviews (Behavioral)
Metastatic Colorectal Cancer Patients Partners
We anticipate enrolling up to a total of 18 partners of patients who have been diagnosed with metastatic colorectal cancer; 12 partners will participate in the qualitative interview, and 6 paartners will participate in the cognitive interview.
干预措施: Cognitive Interviews (Behavioral)
Clinicians
We anticipate enrolling 12 clinicians (including physicians, nurse practitioners, physician assistants, mental health providers, other advanced practice clinicians) who treat patients with colorectal cancer at the University of Colorado to participate in qualitative interviews. We seek to enroll a variety of clinicians from advanced practiced clinical roles (physicians, nurse practitioners, and mental health providers) to capture diverse perspectives.
干预措施: Qualitative interview (Behavioral)
结局指标
主要结局
Identify the preferences of mCRC patients' partners for intervention content
时间窗: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients for intervention format (eg, session length)
时间窗: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients partners for intervention format
时间窗: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients for intervention content
时间窗: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Identify the needs of mCRC patients' partners for intervention content
时间窗: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Extract key themes to integrate into preliminary drafts
时间窗: During the one-time qualitative interview
analyze these qualitative data to extract key themes and will integrate the findings with preliminary drafts of the MIND-Together protocol (e.g., participant handouts, therapist manual).
Identify the needs of mCRC patients for intervention content
时间窗: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients' partners for intervention format (eg, session length)
时间窗: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
次要结局
未报告次要终点