Using Information Technology to Improve Outcomes for Children Living With Cancer

Cancer Clinical Trial

— SyMon-SAYS  

Official title:

Using Information Technology to Improve Outcomes for Children Living With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04789720
• Other study ID #: 1U01CA246612-01
• Secondary ID: 1U01CA246612-01
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: Jin-Shei Lai, PhD
• Phone: 312-503-3370
• Email: js-lai[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Ann & Robert H Lurie Children's Hospital of Chicago, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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