Using Information Technology to Improve Outcomes for Children Living With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Adherence to intervention
研究概览
简要总结
This proposed study plans to develop and evaluate a patient-oriented, technology-based, symptom monitoring system that reports symptoms experienced by children with cancer to their parents and health care providers.
详细描述
Cancer is a leading cause of death and disability in children under 15 years of age. Its unrelieved symptoms and side effects of often-aggressive treatments can lead to poor psychosocial functioning and decreased health-related quality of life (HRQOL) for patients and their families. Barriers at the patient, healthcare provider and system levels can contribute to poor symptom management. A technology-based program can minimize these barriers by routinely collecting and interpreting patient-reported outcomes (PROs) and patient/parent contextual data in pediatric oncology ambulatory settings in a manner that is efficient, actionable by physicians, supports engagement of patients and families with their health and care, and improves clinical processes and outcomes. This proposed project will develop and evaluate the effectiveness of such a program: Symptom Monitoring & Systematic Assessment and Reporting System in Young Survivors (SyMon-SAYS). We hypothesize that the SyMon-SAYS intervention will decrease parent-perceived barriers to managing their child's symptoms, decrease patient symptom burden, increase patients' and parents' self-efficacy, and ultimately increase patient HRQOL.
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
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an hematology/oncologic diagnosis (including a brain tumor)
- •Be on-treatment or within 6 months post-therapy
- •Be between 8 and 17 years old
- •English-speaking
- •Have sufficient cognitive and motor abilities to complete survey via an electronic device (e.g., smartphone, iPAD, etc.) or computer
- •Be able and willing to sign assent forms (for those 12-17 years old).
- •Parent/legal guardian
- •Be a parent (father or mother) or a legal guardian of eligible patients
- •Demonstrates sufficient English and/or Spanish ability to understand and sign the informed consent form
- •Have sufficient cognitive and motor abilities to complete survey via an electronic device (e.g., smartphone, iPAD, etc) or computer
排除标准
- •Patients who cannot understand English sufficiently to sign consent/assent form
- •Patients who cannot understand English sufficiently to complete the questionnaires
研究组 & 干预措施
SyMon-SAYS Intervention (Group A)
Group A participants will receive the SyMon-SAYS intervention every week for 16 weeks.
干预措施: Symptom Monitoring & Systematic Assessment and Reporting System in Young Survivors (SyMon-SAYS) (Behavioral)
SyMon-SAYS Waitlist Control (Group B)
The waitlist control group participants (Group B) will receive their usual care during weeks 1-8 and will receive the SyMon-SAYS intervention every week during weeks 9-16.
干预措施: Symptom Monitoring & Systematic Assessment and Reporting System in Young Survivors (SyMon-SAYS) (Behavioral)
结局指标
主要结局
Adherence to intervention
时间窗: 16 weeks for Group A and 8 weeks for Group B
The adherence to the SyMon-SAYS Intervention will be evaluated by using the percentage of dyads completing the symptom assessments at all time-points (16 weeks for Group A participants and 8 weeks for Group B participants), excluding those who are off-study or deceased.
Overall symptom burden
时间窗: change from baseline to week 8; and from week 9 to week 16
Evidence of decreased or maintained symptom burden as measured by the SyMon-SAYS symptom checklist from baseline to week 8 (primary analysis) and from week 9 to week 16. Each symptom is rated by using a 5-point rating scale and will be evaluated separately. Higher scores represent worse symptom burden.
Perceived symptom management barriers as reported by parents of patients
时间窗: change from baseline to week 8; and from week 9 to week 16
Evidence of decreased or maintained perceived symptom barriers as measured by a modified 23-item Symptom Management Barriers Questionnaire checklist from baseline to week 8 (primary analysis) and from week 9 to week 19. Possible scores range from 23 - 115. Higher scores represent more perceived barriers.
Self-Efficacy
时间窗: change from baseline to week 8; and from week 9 to week 16
Evidence of improved or maintained self-efficacy in managing symptoms related to cancer therapy as measured by using the NIH Toolbox Self-Efficacy (child self-reported version) from baseline to week 8 and from week 9 to week 16. Scores will be reported by using a T-score metric, with a general population mean=50 and SD=10. Higher scores represent better self-efficacy.
Health related quality of life
时间窗: change from baseline to week 8; and from week 9 to week 16
Evidence of improved or maintained health related quality of life (physical function, fatigue, depressive symptom, anxiety, anger, social functioning), as measured by the pediatric Patient Reported Outcome Measurement Information System, PROMIS, (child self-report version) from baseline to week 8 as well as from week 9 to week 16. Scores will be reported by using a T-score system, in which mean of the norming group =50 and SD=10. Higher scores represent better functioning (mobility, upper extremity function, peer relationships) or worse symptoms (depression, anxiety, anger and fatigue).
次要结局
未报告次要终点
研究者
Jin-Shei Lai
Profesor, Medical Social Sciences and Pediatrics, Northwestern University Feinberg School of Medicine.
Northwestern University