Quality of Life and Psychological Distress in Patients With Multiple Myeloma and Their Caregivers
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- Quality of life (QOL) Patient Description
研究概览
简要总结
The main purpose of this study is to examine differences in quality of life and psychological distress for both Multiple Myeloma patients receiving treatment and their caregivers and to assess patient and caregiver prognostic understanding (understanding of the likely course of a disease over time) of Multiple Myeloma to guide development of more personalized treatment plans.
This study looks to further understand quality of life changes throughout multiple myeloma therapy for both patients and caregivers to help determine ways to improve patient and caregiver understanding of illness and in turn, tailor customized treatment that best aligns with patient preferences.
The study will use a series of questionnaires to measure quality of life, mood, coping strategies, and prognostic understanding.
详细描述
This research study's procedures include screening for eligibility, participant designation of a caregiver and a series of questionnaires.
- It is expected that about 180 people undergoing treatment for multiple myeloma and up to 180 of their caregivers will take part in this research study.
-- The questionnaires are completed one time only and measure quality of life, mood, coping strategies, and prognostic understanding and can be completed in the hospital, clinic, over the email, or telephone with assistance provided as needed.Questionnaires take approximately 20 minutes to complete.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Eligibility criteria:
- •Adult patients (greater than 18 years) receiving active therapy for MM.
- •For patients with newly diagnosed MM, patients are eligible while undergoing induction therapy prior to received autologous stem cell transplant but not after.
- •Ability to read questions in English or willing to complete questionnaires with the assistance of an interpreter.
- •Caregiver Eligibility criteria:
- •Adult (greater than 18 years) relative or a friend of a patient who agrees to participate in the study whom the patient identified as living with them or having in-person contact with him or her at least twice per week.
- •Ability to read and respond to questions in English or to complete questionnaires with minimal assistance of an interpreter
排除标准
- •Patient Exclusion criteria:
- •Patients receiving maintenance therapy only.
- •Significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits informed consent or participation in the study.
结局指标
主要结局
Quality of life (QOL) Patient Description
时间窗: Up to 1 year
Describe patient QOL scores by lines of therapy. Functional Assessment of Cancer Therapy-Multiple Myeloma(FACT-MM) will be used to assess QOL, which has been validated for use in multiple care settings.\[10\]. The FACT-MM consists of four subscales assessing well-being across four domains (physical, functional, emotional, and social). These self-reported measures possess strong psychometric properties and have been validated for patients with cancer \[Appendix E\].
Quality of life (QOL) Caregiver Description
时间窗: Up to 1 year
Describe cargiver QOL scores by associated patient line of therapy
次要结局
- QOL-Functional Assessment(Up to 1 year)
- Patient Fatigue Symptoms(Up to 1 year)
- Patient Post-traumatic stress symptoms(Up to 1 year)
- Patient coping(Up to 1 year)
- Caregiver Burden(Up to 1 year)
- Patient Burden Assessment-ESAS(Up to 1 year)
- Caregiver anxiety(Up to 1 year)
- Patient anxiety symptoms(Up to 1 year)
- Patient Depression symptoms(Up to 1 year)
- Caregiver Depression(Up to 1 year)
- Caregiver Coping(Up to 1 Year)
- Caregiver Quality of Life (QOL)(Up to 1 year)
研究者
Elizabeth O'Donnell
Principal Investigator
Massachusetts General Hospital