Evaluation of an Anxiety Intervention for Older Adults With Cancer and Informal Caregivers of Older Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intervention feasibility
研究概览
简要总结
The purpose of this study is to examine the feasibility and acceptability of and patient adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety in older adults (65 years and older) with cancer and their primary informal caregiver. This study will also examine whether the intervention has a clinically significant impact on patient anxiety (primary outcome) and depression, distress, and quality of life (secondary outcomes).
详细描述
This study is a single arm pre-post evaluation of a six-session telephone-administered cognitive-behavioral therapy (CBT) intervention for anxiety in older adults with cancer and their primary informal (unpaid) caregiver. The primary purposes of this study are to evaluate the feasibility of the intervention and study procedures, acceptability of the intervention to older adults with cancer and their primary informal caregiver, and patient and caregiver adherence to the intervention. The secondary purpose is to examine changes in patient and caregiver anxiety, depression, distress, and quality of life pre to post intervention to determine whether the intervention has a clinically significant impact on these outcomes. Anxiety is the primary outcome; depression, distress, and quality of life are secondary outcomes. Patients will be 65 years of age or older and will be recruited from the myeloma, lung, lymphoma, gynecologic, and gastrointestinal cancer clinics at a single institution. Study measures will be administered by telephone prior to initiating the intervention (pre-intervention) and following intervention completion (post-intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 65 years or older
- •Diagnosis of cancer
- •Patient and/or caregiver score of 8 or higher on the anxiety subscale of the Hospital Anxiety and Depression Scale
- •A primary informal caregiver who is willing and able to participate
- •Patient and caregiver are able to communicate over the telephone
- •Caregiver is age 21 years or older.
排除标准
- •Patient or caregiver is not fluent in English
- •Patient or caregiver is too weak or cognitively impaired to participate in the intervention
- •Patient or caregiver has received CBT since the patient's cancer diagnosis
- •Patient or caregiver has an active major psychiatric condition such as schizophrenia
- •Patient only experiences anxiety in the context of a specific medical procedure
- •Patient or caregiver endorses active suicidal ideation
结局指标
主要结局
Intervention feasibility
时间窗: Post-intervention (6-8 weeks after baseline)
Attrition rates
Intervention acceptability
时间窗: Post-intervention (6-8 weeks after baseline)
Likert scale ratings of perceived helpfulness and readability of the intervention
Patient/caregiver adherence
时间窗: Post-intervention (6-8 weeks after baseline)
Sum of number of intervention exercises completed with number of sessions completed by patients and caregivers
次要结局
- Emotional health-related quality of life(Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline))
- Change in depression from baseline to post-intervention(Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline))
- Change in anxiety from baseline to post-intervention(Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline))
- Change in distress from baseline to post-intervention(Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline))