The Brief Sleep Disturbance Scale: Measuring Sleep Disturbance Among Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 2
- 主要终点
- Sensitivity of Brief Sleep Disturbance Scale (BSDS)
研究概览
简要总结
Objectives:
Primary Objectives:
- To establish concurrent criterion-related validity of the Brief Sleep Disturbance Scale (BSDS) by correlating the scale with the Pittsburgh Sleep Quality Index.
- To evaluate the construct validity of the BSDS through exploratory factor analysis.
- To examine possible predictors of sleep disturbance.
- To evaluate the reliability of the BSDS using Cronbach's coefficient alpha and test-retest reliability.
- To evaluate the sensitivity of the BSDS by administering it to the same group of patients (n = 60) prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment.
- To evaluate the psychometric properties of the BSDS in a sample of community dwelling adults.
Secondary Objective:
- To obtain pilot data from a small sample of patients who will wear an actigraph for one week.
详细描述
Patients Who Complete the Surveys on Multiple Time Points:
This study will teach researchers about changes in your sleep patterns that may happen during your cancer treatment. The participants will be recruited from the Melanoma Clinic.
If you agree to take part in this study, during your cancer treatment, you will be asked to complete three written questionnaires that ask about your sleep, symptoms, and mood. These questionnaires will take about 20 minutes to complete. You will be asked to complete the questionnaires before, during and after your cancer treatment during 11 of your clinic visits.
You will also be asked to fill out a sleep diary at home, in which you will be asked to record what time you go to bed, whether you get up during the night, and what time you wake up. You will be asked to fill out the diary every day, for one week. You will be asked to return it during a clinic visit or by mail, with a stamped envelope that will be provided.
During the study, the research staff will collect information from your medical chart about your cancer, cancer treatment, and laboratory tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Outpatient or inpatient receiving evaluation, treatment, or follow-up care at MDACC or a collaborating site.
- •Has a pathological diagnosis of cancer.
- •18 years of age or older.
- •Able to understand English.
- •Gives informed consent to participate.
- •Community sample eligibility: Community dwelling adult who attends a meeting of a designated service organization.
- •Community sample eligibility: 18 years of age or older
- •Community sample eligibility: Gives Informed Consent to participate.
- •Community sample eligibility: Able to understand English.
排除标准
- •Cannot understand the intent of the study.
- •Patient feels too ill to complete the surveys.
- •Refuses to participate.
- •Community sample exclusion criterion: Unable to complete the surveys.
- •Community sample exclusion criterion: Refuses to participate.
- •Community sample exclusion criterion: Cancer diagnosis (past or present).
结局指标
主要结局
Sensitivity of Brief Sleep Disturbance Scale (BSDS)
时间窗: Administering to same group prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment.
次要结局
未报告次要终点