A Distress Screening and Intervention in Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire-8
研究概览
简要总结
The goal of this project is to examine initial effectiveness of a brief (2 preoperative, 2 postoperative session) cognitive behaviorally-based telephone intervention compared to standard care on postoperative outcomes for patients who are scheduled to undergo a cancer-related surgery in 12 or more days and screen positive for distress (4 or higher on 0-10 Distress Thermometer). The intervention focuses on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care. Participants will be randomly assigned to receive the intervention or to receive standard care. Outcomes assessed 4 and 6 weeks post-operatively will include: Depression (Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7), health-related QOL (SF-36 MCS and PCS), number and type of complications, length of stay, and 30-day readmission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •ADULT (18 years of age or older)
- •SCHEDULED FOR SURGERY FOR CANCER (excluding non-melanoma skin cancer) 12 OR MORE DAYS IN ADVANCE OF CONSENT
- •SIGNIFICANTLY DISTRESSED (>4 on the 0-10 Distress Thermometer)
- •ABLE TO SPEAK ENGLISH
排除标准
- •COGNITIVE IMPAIRMENT : <4 on baseline Mini Cog measure
- •SERIOUS MENTAL ILLNESS: a diagnosis of a bipolar or psychotic disorder (noted in medical record)
- •NON-ENGLISH SPEAKING: This study only involves participants who can speak English.
结局指标
主要结局
Patient Health Questionnaire-8
时间窗: 4-weeks post-operation (+/-1 week)
PHQ-8 assesses depression symptoms; A total score (range: 0-24) will be used with higher scores representing more depressive symptoms.
Generalized Anxiety Disorder-7
时间窗: 4-weeks post-operation (+/-1 week)
The GAD-7 measures anxiety symptoms; A total score (range: 0-21) will be used with higher scores representing more anxiety symptoms.
次要结局
- Hospital Readmission(30 days post-operation)
- Number of Complications(30 days post-operation)
- Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS)(4-weeks post-operation (+/-1 week))
- Length of post-operative hospital stay(30 days post-operation)
- Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS)(4-weeks post-operation (+/-1 week))
研究者
Chelsea Ratcliff
Adjunct Assistant Professor
Baylor College of Medicine