Improving Cancer Outcomes Through Personalized Care Planning and Symptom Managment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Outcomes for Primary Aim 1 - 50 intervention participants with a diagnosis for lung, breast or ovarian cancer measuring the prevalence and severity of 18 different symptoms reported from home over 3 months.
研究概览
简要总结
This Study is a case control Study conducted with 100 patients with a solid tumor cancer diagnosis (lung, breast, or gynecologic cancer). Records of 50 patients who received treatment plans as standard of care will be abstracted for control data. 50 patients undergoing cancer treatment will receive a treatment plan and report symptoms using Carevive PROmPT™.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants must be 18 years of age or older.
- •Subject participants must have a diagnosis of a breast, lung, or gynecologic cancer.
- •Patients must have completed their navigation visit and received a Treatment Care Plan.
- •Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
- •Subjects must be starting or receiving treatment.
- •All participants must be able to understand English.
排除标准
- •Any patient who cannot understand written or spoken English.
- •Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
- •Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
结局指标
主要结局
Outcomes for Primary Aim 1 - 50 intervention participants with a diagnosis for lung, breast or ovarian cancer measuring the prevalence and severity of 18 different symptoms reported from home over 3 months.
时间窗: 10 months
Aim 1 is to compare treatment side effect frequency and intensity and patient treatment adherence between Intervention and Control subjects. Data collection for this Aim includes side effect frequency and intensity and time on treatment. Patients in the intervention arm will complete the Core Assessment prior to enrollment as standard of care. They will be enrolled to use the Carevive PROmpt™ platform to access from home. Patients will be instructed to report symptoms once a week between clinic visits. Outcomes measures for this Aim are the prevalence and severity of symptoms in each group, adherence to symptom reporting from home in intervention participants, and time on treatment from enrollment to 3 months after enrollment. Prevalence will be determined by the number of symptom alerts per patient over 3 months/ Severity will be determined by the number of mild, moderate, severe, and very severe over 3 months.
次要结局
- Outcomes for Secondary Aim 2 - 50 intervention patients will complete the Patient Satisfaction Survey at the 3month timepoint to measure satisfaction with treatment decision and care experience.(10 months)
- Outcomes for Secondary Aim 3 - Feasibility will be measured by completion of the patient questionnaires and patient symptom reports by the 50 intervention patients. Usability will be measured through provider feedback.(10 months)