Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Proportion of participants requiring a hospital admission or emergency department visit
研究概览
简要总结
This research study is evaluating a program that entails remote monitoring and home-based care for people with cancer who are receiving chemotherapy, radiotherapy, or chemoradiotherapy.
详细描述
Participants receiving treatment for cancer often require multiple care visits and may experience significant symptoms and side-effects related to the cancer and the cancer treatment.
This research study is evaluating if a program that involves remote monitoring and home-based care may improve the quality of life, ability to manage symptoms, and overall care of individuals during cancer treatment. Remote monitoring is broadly defined as a way of monitor outside of conventional clinical settings (e.g. in the home) that often utilizes technology to increase access to care.
Eligible participants will be randomized into one of two groups:
- Usual Care or
- Supportive Oncology Care at Home
It is expected that about 300 people will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •To be eligible, patients must be: age 18 or older
- •Receiving definitive treatment (i.e. neoadjuvant chemotherapy and/or chemoradiation with curative intent) for pancreatic, gastroesophageal, rectal, head and neck cancer, or lymphoma
- •Within two weeks of starting treatment
- •Planning to receive care at Massachusetts General Hospital (MGH)
- •Verbally fluent in English
- •Residing within 50 miles of Massachusetts General Hospital
排除标准
- •Patients with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written or electronic informed consent.
研究组 & 干预措施
Usual Care
Participants assigned to the standard care arm will receive standard oncology care and attend regular clinic visits. Participants on the standard care arm will complete questionnaires from baseline up to 6 months following enrollment.
干预措施: Usual Care (Other)
Supportive Oncology Care at Home
The research study procedures include:
- Remote monitoring of symptoms, vitals, and body weight
- Questionnaires asking about demographic information (e.g. gender, ethnicity, income) and experience with cancer (e.g. quality of life, symptoms)
- Data collection from medical record
干预措施: Supportive Oncology Care at Home (Other)
结局指标
主要结局
Proportion of participants requiring a hospital admission or emergency department visit
时间窗: baseline to 6 months
Compare the difference between study arms using Fisher's exact tests, and logistic regression, adjusted for any potential confounders that are imbalanced between the two groups at baseline (e.g. age, gender).
次要结局
- Comparison of dose intensity(baseline to 6 months)
- Change in psychological distress (HADS)(baseline to 6 months)
- Proportion of days participants spend outside of the hospital during the study period(baseline to 6 months)
- Change in symptom burden (ESAS)(baseline up to 6 months)
- Change in care satisfaction (FAMCARE)(baseline to 6 months)
- Change in Instrumental Activities of Daily Living (IADLs)(baseline to 6 months)
- Proportion of patients needing an urgent visit to clinic(baseline to 6 months)
- Rate of treatment delays(baseline to 6 months)
- Change in quality of life (FACT-G)(baseline to 6 months)
- Change in Activities of Daily Living (ADLs)(baseline to 6 months)
研究者
Ryan Nipp
Principal Investigator
Massachusetts General Hospital