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临床试验/NCT04275102
NCT04275102尚未招募不适用

A Feasibility Study of Three Times Weekly Symptom Screening for Children With Cancer

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks.

研究概览

简要总结

This study will evaluate the feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks. SPARK is a web-based application that promotes symptom screening for children receiving cancer therapies and enables access to clinical practice guidelines for symptom management. Newly diagnosed and relapsed patients with cancer will be enrolled. Children and/or their guardian will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.

详细描述

Primary objective is to determine the feasibility of three times weekly symptom reporting by guardians and children using the SPARK platform for 8 weeks. Feasibility will be evaluated by compliance with symptom screening and the investigators anticipate that at least 75% can achieve compliance with at least 60% of symptom evaluations.

Newly diagnosed and relapsed patients with cancer 2-18 years of age will be enrolled Children will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.

Patient-reported outcomes will be obtained at baseline, and weeks 4, and 8. These outcomes will include the Symptom Screening in Pediatrics Tool (SSPedi), Fatigue will be measured using PROMIS, and the Pediatric Quality of Life Inventory (PedsQL) 3.0 Acute Cancer Module. Data from health records will be abstracted for all enrolled participants to evaluate symptom documentation and intervention provision at times symptom screening is completed as well as emergency room visits, clinic visits and hospitalizations.

Analyses are descriptive. The investigators' primary outcome is feasibility, sample size justification will focus on having sufficient number of guardians and children to optimize study processes and to describe the number of completed symptom assessments. The investigators will enroll up to 20-30 children per site per cohort; it is anticipated the investigators can enroll this number over one year. The 95% confidence intervals assuming 60% compliance will be 36-81% and 41-77% for 20 and 30 participants respectively; this precision is adequate for research purposes. If it is found that the processes are not feasible, the data will be reviewed after the initial cohort and enact refined procedures to rectify the identified problems. In this case enrollment of another 20-30 children per site per cohort with the updated procedures for a total sample size of 40-60 participants per site.

Primary objective of feasibility of responsive respondent type will be to evaluate the feasibility of eliciting bothersome symptoms using co-SSPedi, mini-SSPedi, co-mini-SSPedi, SSPedi or proxy-SSPedi. We will include children with cancer who: (1) are 2-18 years of age at enrollment; (2) are English, French or Spanish speaking (SSPedi is validated in these languages); (3) have any cancer diagnosis regardless of relapse status (4) have received or have a plan to receive any chemotherapy, radiotherapy or surgery. Exclusion criteria will be cognitive disability or visual impairment (cannot see SPARK even with corrective lens).

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
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • cancer diagnosis
  • 2-18 years of age at enrollment
  • Child has received or a plan for any chemotherapy, radiotherapy or surgery
  • Understands English, French or Spanish

排除标准

  • Cognitive disability
  • Visual impairment (cannot see SPARK even with corrective lens)

结局指标

主要结局

Feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks.

时间窗: 8 weeks

The primary endpoint is feasibility, defined as at least 75% achieving compliance with at least 60% of symptom evaluations among guardian and self-report populations.

次要结局

  • Symptom burden as measured by the total SSPedi score Total SSPedi symptom scores(Baseline and weeks 4, and 8)
  • QoL will be measured using the PedsQL 3.0 Acute Cancer Module(Baseline and weeks 4, and 8)
  • Nausea as measured by the Pediatric Nausea Assessment Tool(Baseline and weeks 4, and 8)
  • Pain as measured by PROMIS Pain Interference(Baseline and weeks 4, and 8)
  • Symptom documentation(Baseline and weeks 4, and 8)
  • Number of Patients' Emergency Department Visits, Unplanned Clinic Visits and Hospitalizations over the 8-week intervention(Baseline and weeks 4, and 8)
  • Fatigue(Baseline and weeks 4, and 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lillian Sung

Principal Investigator

The Hospital for Sick Children

研究点 (2)

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