Quality of Life Study Registry for Persons With Cancer and Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 863
- 试验地点
- 1
- 主要终点
- Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year
研究概览
简要总结
RATIONALE: Studying quality-of-life in patients having cancer treatment and in their caregivers may help identify the intermediate- and long-term effects of treatment on patients with cancer and on their caregivers.
PURPOSE: This clinical trial is studying quality of life of older patients who are undergoing treatment for cancer and of their family caregivers.
详细描述
OBJECTIVES:
- Obtain quality of life and psychosocial data from older patients who are undergoing treatment for cancer and from their family caregivers.
OUTLINE: This is a pilot, cross-sectional study.
Patients undergo a 45-minute interview in person or by phone to provide demographic data and to complete quality of life questionnaires, including Functional Assessment of Cancer Therapy (FACT), Spiritual tool, Quality and Satisfaction with Treatment (QUEST), and Profile of Mood State (POMS), at baseline and at 3 and 12 months. Caregivers undergo a 20- to 30-minute interview in person or by phone to provide demographic data and complete quality of life questionnaires, including the Caregiver Reaction Assessment (CRA), Quest, and POMS, at baseline and at 3 and 12 months. Caregivers complete the Quality of Death and Dying (QODD) questionnaire 2-3 months after the patient's death.
PROJECTED ACCRUAL: Not specified
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Functional status by Karnofsky and ECOG at baseline, 3 months, and 1 year
时间窗: at baseline, 3 months, and 1 year
Co-morbidities by Charlson at baseline
时间窗: at baseline
Cognitive status by Short Orientation Concentration Memory Test at baseline, 3 months, and 1 year
时间窗: at baseline, 3 months, and 1 year
Quality of Life (QOL) by SF-12 at baseline
时间窗: at baseline
QOL and Symptoms by Functional Assessment of Cancer Therapy-General (FACT-G) at baseline, 3 months, and 1 year
时间窗: at baseline, 3 months, and 1 year
Spirituality by Functional Assessment of Chronic Illness Therapy (FACIT)-Sp at baseline, 3 months, and 1 year
时间窗: at baseline, 3 months, and 1 year
Caregiver Burden by Caregiver Reaction Assessment at baseline, 3 months, and 1 year
时间窗: at baseline, 3 months, and 1 year
Social Support by Shortened Social Support Scale at baseline, 3 months, and 1 year
时间窗: at baseline, 3 months, and 1 year
Satisfaction with care by FACIT-TS-PS at 3 months and 1 year
时间窗: at 3 months and 1 year
Mood state by Profile of Mood States at baseline, 3 months, and 1 year
时间窗: at baseline, 3 months, and 1 year
Optimism by Life Orientation Test at baseline
时间窗: at baseline
次要结局
- Trends over time (mood state, satisfaction, symptoms, QOL, caregiver burden, and cognitive status) for patient and caregiver by the tools listed above at 3 months and 1 year(at 3 months and 1 year)