Adaptation, Feasibility and Acceptability Study of the Advanced Symptom Management System (ASyMS) Mobile Health Intervention to Reduce Chemotherapy Toxicities in Canadian Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
The Advanced Symptom Monitoring and Management System - Canada (ASyMS-Can) is a remote phone-based symptom management system that prompts patient self-care and clinician telephone triage and intervention based on alerts for managing cancer treatment side effects such as nausea and vomiting, fatigue, etc. ASyMS-Can is an android phone-based application that is given to patients to self-report their symptoms using a patient reported outcome symptom questionnaire and level of severity daily, on a secure mobile android phone, from home or outside of clinics. Based on back-end computations, patients receive automated self-care notifications on their mobile phones with advice on self-care for mild to moderate severe symptoms. The system also in the case of severe symptoms will alert the designated clinic nurse to prompt electronic telephone triage and intervention (yellow alert response in 4 hours or within 30 minutes for severe symptoms-red alert).
详细描述
In addition, patients can access a self-care library and symptom graphs (detailing trends in individual symptoms experienced) through the ASyMS-Can patient phones. If the incoming symptom reports are of clinical concern, the server software will generate two levels of alerts (amber& red) that will be sent to the designated nurse, who will receive alerts on a dedicated ASyMS-Can nurse handset (mobile phone). The nurse will view the patient's symptom reports on a secure web page, and contact the patient directly at home by telephone, guided through a decision-support algorithm on the web-based platform to systematize the triage based on the COSTARS guideline, facilitating the initiation of "real-time" clinical interventions. An "amber alert", which requires response within 4 hours, indicates that the symptom(s) are not severe or life-threatening but early intervention might prevent further symptom progression. The second level of the triage alert, 'red alert', will be sent to the nurse for severe symptoms and will require response within 30 minutes of receipt of the alert
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
- Single (Outcomes Assessor)
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 early stage breast, colorectal, and lymphoma (Hodgkin's [HD], non- Hodgkin's [NHL].
- •Scheduled to receive 2-, 3- or 4-weekly chemotherapy protocols (i.e. chemotherapy administered at repeated cycles of 14, 21 or 28 days, respectively).
- •Scheduled to receive a minimum of 3 cycles of systemic chemotherapy (any regimen); adjuvant or neo-adjuvant on an out-patient basis;
- •Adults >=18 years of age;
- •Able to provide written consent and willing to participate;
- •Adequate ability to use or be trained in use of a mobile phone for symptom reporting
排除标准
- •Enrolled/receiving an investigational treatment;
- •Scheduled to receive concurrent radiotherapy during chemotherapy treatment.
- •Scheduled to receive weekly chemotherapy protocols. In addition, patients who shift from a 2-, 3- or 4-weekly protocol to a weekly protocol during chemotherapy will be excluded from further participation in the study.
- •Any distant metastasis based on Ann Arbor or TNM staging
- •Unable to speak/read/write English sufficiently to complete study measures.
- •Unable to complete study measures due to a pre-existing disability (e.g. visually impaired)
- •Cognitive impairment/severe pre-existing emotional issues as assessed by the treatment team which may impede completion of study measures.
- •Low performance status (ECOG > or =3)
研究组 & 干预措施
ASyMS-Can
TParticipants assigned to the experimental group will be provided with the encrypted, secure, pre-programmed ASyMS-Can android phone, and instructed of its use; how to report their symptomatology on a twice daily basis using the CTAQ for the first 14 days of each treatment cycle until end of the final cycle of treatment (or up to 16 weeks).
干预措施: ASyMS-Can (Device)
Control
Control group will be asked to complete the study questionnaires at your clinic visits. Also, research staff will contact participants at 1 to 14 days following each chemotherapy, mid and end of each chemotherapy appointment and again within week 8 and 16 of your participation to collect information about participants' symptoms.
结局指标
主要结局
Feasibility of recruitment
时间窗: Recruitment rate aim is 7-8 patients/month, for 1 year.
Recruitment Rate (RRa)
次要结局
- Health Service Utilization(End of each chemotherapy cycle (Week 2-3, or 4-5 - dependent on chemotherapy regimen being given).)
- Symptom Severity(Baseline (within 1 week before 1st chemotherapy cycle). Mid-way each chemotherapy cycle, (Day 6-8, 9-11, or 13-15 - dependent on number of days in the chemotherapy cycle).)
- Self-Efficacy for Coping(Baseline (within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given), and end of treatment (Week 6-8 or 14-16-dependent on chemotherapy regimen being given).)
- Health Related Quality of Life(Baseline(within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given), and end of treatment (Week 6-8 or 14-16-dependent on chemotherapy regimen being given).)
- Information and Support Needs(Baseline(within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given).)
- Acceptance, Patient User/Satisfaction, System Usefulness, Information Quality and Interface Quality of User Interface(End of study (Week 16))
- Clinicians' acceptance(End of study (Week 16))
- Chemotherapy Self-Management Behaviours(Midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given).)
- Psychological Distress(Baseline(within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given), and end of treatment (Week 6-8 or 14-16-dependent on chemotherapy regimen being given).)