Are Last Impressions Lasting Impressions? Intervention of Ringing a Bell at the End of Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Distress memory scales as assessed by the 11-point Numeric Rating Scale
研究概览
简要总结
This clinical trial studies how well ringing a bell on the final day of radiation therapy works in improving the memory of distress in cancer patients. Ringing a bell on the final day of radiation therapy may improve the memory of how painful the treatment was.
详细描述
PRIMARY OBJECTIVES:
I. To determine if the simple act of ringing a bell at the end of radiotherapy can improve the retrospective evaluation of distress due to radiotherapy and other prior cancer therapy.
SECONDARY OBJECTIVES:
I. To measure the severity of patients' memory of distress from cancer treatment.
II. To assess the relationship between anxiety to actual distress and to remembered distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Diagnosis of cancer
- •Definitive radiation treatment with or without concurrent chemotherapy with curative intent; treatment prior to radiation therapy is acceptable (e.g. surgery, chemotherapy)
- •Ability to understand and the willingness to sign a written informed consent; consents will be provided in English or Spanish
- •Able to speak English or Spanish (questionnaires will be in English and Spanish)
排除标准
- •Patients with either a malignant central nervous system (CNS)-primary cancer or with brain metastases; patients do not need to undergo brain imaging unless indicated per standard workup and management (e.g. advanced stage lung cancer receiving definitive therapy)
- •Patients who will be receiving surgery or adjuvant chemotherapy within 1 month following radiation treatment
- •Patients with widespread metastatic disease (> 3 distant metastases); patients with oligometastatic disease (=< 3 distant metastases) are allowed only if they are receiving definitive (curative) radiation therapy (RT) with or without chemotherapy
结局指标
主要结局
Distress memory scales as assessed by the 11-point Numeric Rating Scale
时间窗: Up to 7 months
Patient baseline characteristics and treatment will be summarized in groups A and B. Repeated measures analysis of variance (ANOVA) will be used to compare distress memory scales between patients in group A and group B. A mixed regression model will be used to examine the effect of ringing the bell on the last day of radiotherapy on distress memory scales when considering covariates such as baseline patient characteristics, cancer type, radiotherapy total dose and duration, baseline distress scale, analgesic medication, disease recurrence status, optimism/pessimism personality and anxiety.
次要结局
- Anxiety level as assessed by Generalized Anxiety Disorder 7 scale(Up to 7 months)
- Optimism-pessimism scores as assessed by the Life Orientation Test-Revised(Up to 7 months)