A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Cancer patient's quality of life (QOL) as measured by the FACT-G global summary score
研究概览
简要总结
This randomized clinical trial studies structured multidisciplinary intervention or standard medical care in improving quality of life (QOL) in patients receiving active cancer treatment. A structured multidisciplinary intervention may improve the QOL in patients receiving treatment for cancer. It is not yet known whether structured multidisciplinary intervention is more effective than standard medical care in improving QOL
详细描述
PRIMARY OBJECTIVES:
I. To examine the efficacy of a structured multidisciplinary intervention compared to standard medical care on improving the subject's QOL as measured by the Functional Assessment of Cancer Therapy-General global summary score (FACT-G) at 4 weeks (or at end of the intervention), at 27 weeks and at 52 weeks.
SECONDARY OBJECTIVES:
I. To examine the effect of a structured multidisciplinary intervention compared to standard medical care on improving the subject's psychosocial functioning as measured by the 11 Linear Analogue Self Assessment (LASA) QOL scales, Profile of Mood States (POMS), the Functional Assessment of Chronic Illness Therapy-Spiritual well-being scale (FACIT-SP), Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Control Preferences Scale, and Exercise Behaviors at 4 weeks (or at end of intervention), at 27 weeks and at 52 weeks.
II. To examine the effect of a structured multidisciplinary intervention compared to standard medical care on improving the caregiver's QOL as measured by the Caregiver QOL-Cancer scale, and on their psychosocial functioning as measured by the 11 LASA QOL scales and POMS at 4, 27 and 52 weeks.
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
- •Ability to attend all treatment sessions and follow-up
- •Ability to provide written informed consent
- •Ability to participate in all aspects of the study
- •Initial diagnosis of cancer must have been =< 12 months prior to study entry
- •Intermediate to poor prognosis, defined as an expected 5-year survival of 0-50% in the judgment of the physicians entering the patient on the study
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2
- •>= 1 week of planned cancer treatment at Mayo Clinic
- •Has a caregiver also willing to participate
排除标准
- •Mini-mental state examination (MMSE) scores of < 20
- •Expected survival of < 6 months
- •Active substance abuse (alcohol or drug)
- •Participation in other psycho-social research trials
- •Active thought disorder (bipolar illness, schizophrenia, etc.)
- •Suicidal intent or plan
- •In need of psychiatric hospitalization
- •Recurrent disease after disease-free interval of > 6 months
- •Previous cancer =< 5 years (except non-melanoma skin cancer and/or second cancer diagnosed at approximately the same time as this cancer)
结局指标
主要结局
Cancer patient's quality of life (QOL) as measured by the FACT-G global summary score
时间窗: At baseline and 4, 27, and 52 weeks
The t-test and Wilcoxon test supplemented by repeated measures analytical procedures (analysis of variance \[ANOVA\], Generalized Estimating Equations \[GEE\]) will be used to measure and analyze QOL.
次要结局
- On improving the subject's psychosocial functioning as measured by the 11 LASA QOL scales, Profile of Mood States (POMS), the FACIT-SP, Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Control Preferences Scale, and Exercise Behaviors(At baseline and 4, 27, and 52 weeks)
- On improving the caregiver's QOL as measured by the Caregiver QOLCancer scale, and on their psychosocial functioning as measured by the 11 LASA QOL scales and POMS(At baseline and 4, 27 and 52 weeks)