Using Information Technology to Improve Outcomes for Children Living With Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SyMon-SAYS Intervention (Group A)

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

Group Type EXPERIMENTAL

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

Intervention Type 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 Waitlist Control (Group B)

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.

Group Type OTHER

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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No