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Completed

NCT Number: NCT04789720

Using Information Technology to Improve Outcomes for Children Living With Cancer

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.

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Key information

Conditions

Cancer Neoplasms

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients

  • 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

Exclusion criteria

  • Patients who cannot understand English sufficiently to sign consent/assent form
  • Patients who cannot understand English sufficiently to complete the questionnaires

Treatment and study plan

Symptom Monitoring & Systematic Assessment and Reporting System in Young Survivors (SyMon-SAYS)

Behavioral

Participants will complete a 9-item SyMon-SAYS symptom assessment checklist every week during the intervention phase (Intervention Group: weeks 1-16; Waitlist Control: weeks 9-16) through Epic MyChart via mobile app, computer or tablet. Patients' symptom scores will be monitored and reported to their oncology care providers. When a patient symptom score trigger threshold is met, the system will generate an email alert through Epic (electronic medical record system) messaging to the provider. The provider will take appropriate actions using his/her clinical judgement, including contacting patients and families when needed. Symptom scores overtime will be available in MyChart (patient-facing component of the Epic electronic medical record system) for patients and parents to review and to discuss with the child's provider during clinical visits.

Primary outcomes

  1. Adherence to intervention

    Time frame: 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.

  2. Overall symptom burden

    Time frame: 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.

  3. Perceived symptom management barriers as reported by parents of patients

    Time frame: 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.

  4. Health related quality of life

    Time frame: 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).

  5. Self-Efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • National Cancer Institute (NCI)

Registry information

Acronym: SyMon-SAYS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2021
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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