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

Phase-Based Estimates
1
Effectiveness
1
Safety
Ann & Robert H. Lurie Childrens Hospital of Chicago, Chicago, IL
Symptom Monitoring & Systematic Assessment and Reporting System in Young Survivors (SyMon-SAYS) - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Malignancies

Study Summary

This study is evaluating whether a system can help parents and health care providers monitor symptoms in children with cancer.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Symptom Monitoring & Systematic Assessment and Reporting System in Young Survivors (SyMon-SAYS) will improve 5 primary outcomes in patients with Malignancies. Measurement will happen over the course of 16 weeks for Group A and 8 weeks for Group B.

Week 16
Adherence to intervention
Week 16
Health related quality of life
Overall symptom burden
Perceived symptom management barriers as reported by parents of patients
Self-Efficacy

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
SyMon-SAYS Intervention (Group A)

This trial requires 200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Symptom Monitoring & Systematic Assessment And Reporting System In Young Survivors (SyMon-SAYS) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

SyMon-SAYS Intervention (Group A)
Behavioral
Group A participants will receive the SyMon-SAYS intervention every week for 16 weeks.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to week 8; and from week 9 to week 16
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline to week 8; and from week 9 to week 16 for reporting.

Who is running the study

Principal Investigator
J. L.
Jin-Shei Lai, Profesor, Medical Social Sciences and Pediatrics, Northwestern University Feinberg School of Medicine.
Northwestern University

Closest Location

Ann & Robert H. Lurie Childrens Hospital of Chicago - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
I understand and can sign the informed consent form. show original
countries There are a few English-speaking countries in the world show original
Be able to use a smartphone, iPad, or computer to complete a survey. show original
You must be able to sign assent forms in order to participate in this study if you are between the ages of 12 and 17. show original
Parent/legal guardian
If you are a parent or legal guardian of an eligible patient, you can ask your doctor about clinical trials. show original
Patients
I have a brain tumor. show original
You should either be currently treatment or within 6 months of finishing treatment. show original
You must be between eight and seventeen years old to use this website. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the latest research for malignancies?

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More investigations are needed to assess whether the prognosis varies according to the cancer type by investigating the risk factors and risk factor-related gene polymorphisms.

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Can malignancies be cured?

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There is a growing consensus among health care providers that the treatment of malignancies has not been improved over centuries. Nevertheless, many malignant diseases can be cured by adjuvant treatment. Some malignancies have been cured by the advancement of treatment techniques. Patients who do not have malignancies can still benefit from treatment.

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What are common treatments for malignancies?

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It is quite common and the treatment of lymphoma, [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), melanoma, cancer of the gastrointestinal tract and brain have a high rate of survival. However, the treatment of cancer is highly dependent on the specific patient.

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How many people get malignancies a year in the United States?

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Approximately 80,000 people develop leukemia in the United States each year, of whom approximately 65,000 will achieve hematologic responses to treatment with imatinib, the first targeted therapy. Although more than 20,000 new cases of Burkitt's lymphoma are reported per year, the 5-year survival rate of newly diagnosed patients is more than 100%.

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What causes malignancies?

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There is very strong genetic risk for developing cancers from a number of different genes (cancers). It appears that the risk of developing cancer increases with ageing. Cancers of two types—benign tumours and malignant tumours, especially lung cancer—occur at high rates (10% and 5% respectively). They both arise because of uncontrolled growth in the body, which is caused by an uncontrolled DNA-making process ( cell signalling pathways). Many of the signalling pathways that control the DNA-making process are the same for both benign and malignant cancers. Both types seem to arise through a number of common pathways, and the two types appear to share the same underlying biology (cell signalling pathways and DNA making processes).

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What are the signs of malignancies?

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Clinical symptoms of malignancy vary widely among patients with hematologic malignancies. These include anemia, leukocytosis, thrombocytosis, and fever. They can be caused by the leukemitotic effect of treatment, disseminated intravascular coagulation (DIC), leukemia, myelofibrosis, and metastatic hematological malignancies. Signs of malignancy that may be present without suspicion include a positive CBC, and a positive urinalysis or CAST.

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What is malignancies?

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Malignancies are cancers that form in the body and cause an uncontrolled growth of cells. They may be benign at the start or become malignant after the start. malignancies of hematological, lymphoid, and mesothelial origin may occur. They have become a leading cause of death in the United States. Most commonly occurring forms of cancer in adults are lung cancer and colon, pancreas, prostate, breast, and cervical. Cancer can be detected and diagnosed using imaging, blood tests, or biopsy. In many cases, it is determined by tissue typing. The number of new cases of lung cancer is about 40,900.

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What is symptom monitoring & systematic assessment and reporting system in young survivors (symon-says)?

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The young survivors' group requires a structured systematic symptom monitoring and reporting system during follow-up, a medical summary document and an integrated care plan for any subsequent problems. Young survivors often have problems with coping skills that can help them to cope with adverse experiences to promote recovery.

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What are the latest developments in symptom monitoring & systematic assessment and reporting system in young survivors (symon-says) for therapeutic use?

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There are many challenges facing young survivors who are being assessed in this setting for potential clinical use, for a variety of reasons. We suggest that there are a number of ways that healthcare service providers could use Symon-says® to identify and monitor these risks that may compromise their young survivors' post-treatment health.

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What is the primary cause of malignancies?

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The environmental risk factors in malignancies, including tobacco and alcohol, are more powerful on a global (population-wide) scale than the genetic factors that are most closely related to a particular individual's risk for some specific individual cancers. The specific cancer incidence attributable to these environmental factors is, however, quite substantial.

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Have there been any new discoveries for treating malignancies?

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There have been many breakthrough discoveries for treating malignancies. It is difficult to determine what will actually become standard treatment because the data from clinical trials are often not adequate to make solid recommendations. Clinical trials are often performed on small numbers of patients and have short durations. In many cases, most patients do not receive the therapy due to side effects or lack of effectiveness. More trials are needed so that drugs with improved side effects and improved effectiveness can be put into use.

Unverified Answer

Does symptom monitoring & systematic assessment and reporting system in young survivors (symon-says) improve quality of life for those with malignancies?

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Young cancer survivors and their caretakers can benefit by improving symptoms and psychological and physical health by implementing a symptom monitoring and systematic assessment and reporting system. This has the potential to improve both the physical and mental health of young cancer survivors.

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