Clinical trial NCT04789720: Using Information Technology to Improve Outcomes for Children Living With Cancer
Official title: Using Information Technology to Improve Outcomes for Children Living With Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: children living with cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
name: National Cancer Institute (NCI)
First posted: 2021-03-10
Enrollment: 216
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to intervention
timeFrame: 16 weeks for Group A and 8 weeks for Group B
measure: Overall symptom burden
timeFrame: change from baseline to week 8; and from week 9 to week 16
measure: Perceived symptom management barriers as reported by parents of patients
timeFrame: change from baseline to week 8; and from week 9 to week 16
measure: Health related quality of life
timeFrame: change from baseline to week 8; and from week 9 to week 16
measure: Self-Efficacy
timeFrame: change from baseline to week 8; and from week 9 to week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Childrens Hospital of Chicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jin-Shei Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References: