A Pilot Assessment of a Digital System for Cancer Patient Symptom Reporting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Usability of the computer-based symptom reporting system
研究概览
简要总结
This pilot trial studies the usability and usefulness of a computer-based system for reporting symptoms in patients with cancer undergoing treatment. Cancer patients undergoing cancer treatment are not always comfortable contacting the doctor when experiencing symptoms. A computer based platform, where patients can input symptoms, may seem less intrusive than a phone call and may improve patient access to care.
详细描述
PRIMARY OBJECTIVES:
I. To assess the usability and usefulness of a computer-based system for cancer patient symptom reporting.
SECONDARY OBJECTIVES:
I. To collect preliminary effectiveness data: quality of life outcomes with the Function Assessment of Cancer Therapy - General (FACT-G) and self-efficacy as measured by Chronic Disease Self-Efficacy Scale, Revised (CDSES-R).
OUTLINE: Participants are randomized to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENT: Active outpatient cancer treatment (chemotherapy, immunotherapy, radiation, and hormonal therapy)
- •PATIENT: No clinical evidence of cognitive or psychological impairment.
- •PATIENT: Home internet access on computer or phone.
- •CAREGIVER: Selected family member or close friend of the cancer patient matching the patient inclusion criteria outlined above.
排除标准
- •Inability to provide informed consent.
结局指标
主要结局
Usability of the computer-based symptom reporting system
时间窗: 6 weeks
Assessed with the System Usability Scale (SUS). The SUS is a 10-item 5-point Likert scale usability measure, scored from 0 (least usable) to 100 (most usable). The mean SUS scores (only during the active cancer treatment) will be computed with the corresponding 90% confidence intervals.
Patient-deemed usefulness of computer-based symptom reporting system
时间窗: 6 weeks
Assessed with the Perceived System Usefulness (PSU) scale. The mean PSU scores (only during the active cancer treatment) will be computed with the corresponding 90% confidence intervals.
Effectiveness of the computer-based symptom reporting system (FACT-G)
时间窗: 6 weeks
Evaluated using the quality of life outcome Functional Assessment of Cancer Therapy - General (FACT-G) scale. For the FACT-G, the 4 repeated measures (excluding the baseline) will be analyzed in linear mixed effects models with the random effect of user group (patient and caregiver) and fixed effect of period, sequence. The model will be used to compute the 90% confidence intervals for the mean FACT-G on usual care and on the digital system.
Effectiveness of the computer-based symptom reporting system (CDSES-R)
时间窗: 6 weeks
Evaluated using the self-efficacy Chronic Disease Self-Efficacy Scale, Revised (CDSES-R) scale. For the CDSES-R, the 4 repeated measures (excluding the baseline) will be analyzed in linear mixed effects models with the random effect of user group (patient and caregiver) and fixed effect of period, sequence. The model will be used to compute the 90% confidence intervals for the mean CDSES-R on usual care and on the digital system.
次要结局
未报告次要终点