Real-Time Monitoring of Chemotherapy Side Effects in Patients With Gastro-Intestinal Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Social support
研究概览
简要总结
This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. RT-CAMSS is a monitoring support system that provides patients with evidence-based information and side-effect management and coping skills, emotional support and validation, and proactive care via text messages and questionnaires as they undergo chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) for patients with gastric, esophageal, pancreatic and colorectal cancer during chemotherapy.
II. Assess the feasibility and engagement of the RT-CAMSS in a 2-month pilot study.
III. To gather preliminary data on the impact of RT-CAMSS on patient's quality of life and symptom distress.
OUTLINE:
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
- •Patients diagnosed with gastric, esophageal, pancreatic or colorectal cancer
- •Scheduled to start intravenous (IV) chemotherapy or has started IV chemotherapy
- •Able to read and understand English
- •Able to provide signed and dated informed consent form
- •Have a mobile device with text message capability
- •Know or willing to learn how to use text messaging
排除标准
- •< 18 years of age
- •Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex)
结局指标
主要结局
Social support
时间窗: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
The Multidemensional Scale of Perceived Social Support (MSPSS), a well-validated 12-item instrument used to assess patient perceived social support.
Feasibility and Engagement
时间窗: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Will be measured through study accrual, attrition, and system usage frequencies. We aim for accrual at a rate of 50% to match our prior study but a rate over 30% will be feasible. The intervention will be considered feasible if attrition does not exceed 30%. 90% of participants reporting their symptoms at least once will be considered adequate.
Acceptability
时间窗: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Will be measured through a satisfaction measure and patient interview data. Acceptability will be established by a group median score \>= 3 on the 1-4 satisfaction scale.
Symptom distress
时间窗: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
The Memorial Symptom Assessment Scale (MSAS), a well-validated instrument that will be used to assess common physical symptoms concerning chemotherapy in patients. The MSAS measures the prevalence, frequency, severity, and distress of 25 physical symptoms and seven psychological symptoms.
Self-efficacy
时间窗: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Will be measured using the Patient Activation Measure (PAM) for assessing skills, knowledge and self-confidence for self-management. The scale asks participants concerning their certainty of controlling symptoms caused by chemotherapy to perform daily activities.
Information and support needs
时间窗: Prior to start of chemotherapy treatment
Will be measured using the Cancer Treatment Scale (CaTS). The CaTS assesses patient's preparation prior to the start of their chemotherapy treatment.
Medical information
时间窗: Baseline
Will be extracted from the electronic medical record (EMR) chart including cancer diagnosis information, treatment schedule and discontinuation.
Functional Assessment of Cancer Treatment - General scale
时间窗: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Questionnaire will be used to assess patient quality of life. The 27-item FACT-G assesses four specific domains including physical, social, emotional and functional well-being.
Post-intervention evaluation
时间窗: Through study completion, an average of 2 months
Patient interviews will explore key domains including perceived usefulness, how well the enhanced usual care and the RT-CAMSS address their concerns, whether there are additional issues they would like to see included and the characteristics of the text message.
次要结局
未报告次要终点