Using Information Technology to Improve Outcomes for Children Living With Cancer

NCT04789720 | Completed DMC

• 1 other identifier: 1U01CA246612-01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

children living with cancer

Outcome Measures

Primary Outcomes (5)

• Adherence to intervention

  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.

  16 weeks for Group A and 8 weeks for Group B

• Overall symptom burden

  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.

  change from baseline to week 8; and from week 9 to week 16

• Perceived symptom management barriers as reported by parents of patients

  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.

  change from baseline to week 8; and from week 9 to week 16

• Health related quality of life

  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).

  change from baseline to week 8; and from week 9 to week 16

• Self-Efficacy

  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.

  change from baseline to week 8; and from week 9 to week 16

Study Arms (2)

SyMon-SAYS Intervention (Group A)

EXPERIMENTAL

Group A participants will receive the SyMon-SAYS intervention every week for 16 weeks.

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

SyMon-SAYS Waitlist Control (Group B)

OTHER

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.

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

Interventions

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.

SyMon-SAYS Intervention (Group A); SyMon-SAYS Waitlist Control (Group B)

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ann & Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Lai JS, Jensen SE, Peipert JD, Mitchell SA, Garcia SF, Cella D, Goldman S, Lenzen A. Using IT to Improve Outcomes for Children Living With Cancer (SyMon-SAYS): Protocol for a Single-Institution Waitlist Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 8;12:e50993. doi: 10.2196/50993.

  PMID: 37682593 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jin-Shei Lai, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor, Medical Social Sciences and Pediatrics, Northwestern University Feinberg School of Medicine.

Model Details: Participants will be randomly assigned to Group A (SyMon-SAYS intervention) or B (waitlist-control), stratified by gender, age (8-12 vs 13-17), and type of cancer (brain tumor vs. leukemia vs. others). To achieve allocation concealment, the computer-based data management system will assign participants to one of two groups after the study enrollment procedures. A permuted block sequence will be used. Participants will be informed of their group assignment (Group A or B) after the baseline assessment. Participants will complete a 9-item SyMon-SAYS Weekly Symptom Assessment Scale via Epic MyChart patient portal during the intervention phase (Group A: Wk1-16 or Group B: Wk9-16)

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: March 10, 2021
• Study Start: April 1, 2021
• Primary Completion: August 22, 2025
• Study Completion: August 22, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)