Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

Study Overview
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Brief Summary
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This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

Detailed Description
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PRIMARY OBJECTIVES: I. To develop a mechanism for tracking and retaining patients enrolled on Children's Oncology Group (COG) protocols. II. To maintain regular, lifetime contact with patients in order to obtain current identification and contact information, and self/parent-reported health status. III. To locate patients who are lost-to-follow-up for COG (or Legacy Group) protocols targeted for follow-up by the Long-Term Follow-Up Center (LTFC). IV. To provide current patient contact information and self/parent-reported health status updates to the COG Statistics and Data Center (SDC) and to each patient's COG institution. V. To facilitate collection of protocol-specific outcome data through collaboration with the LTFC Oversight Committee, the SDC, and the member institutions. OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions. Within 3 months of enrollment on ALTE05N1, patients receive a mailed packet introducing the Long-Term Follow-Up Center (LTFC). Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number.

Official Title
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Umbrella Long-Term Follow-Up Protocol

Conditions
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Acute Lymphoblastic Leukemia, Brain Neoplasm, Hematopoietic Cell Transplantation Recipient, Hodgkin Lymphoma, Osteosarcoma, Rhabdomyosarcoma

Intervention / Treatment
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* Procedure: Assessment of Therapy Complications
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must reside in the U.S. on the date of enrollment to ALTE05N1 All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (long-term follow-up)<br>Within 3 months of enrollment of ALTE05N1, patients receive a mailed packet introducing the LTFC. Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number. | Procedure: Assessment of Therapy Complications<br>* Complete patient response form and Health Status Update Form<br>Other: Questionnaire Administration<br>* Complete patient response form and Health Status Update Form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients enrolled |  | Up to 20 years | 
| Percentage of patients in which long-term (20+ years) contact is maintained |  | Up to 20 years | 
| Percentage of eligible patients located who were lost to follow-up |  | Up to 20 years | 
| Percentage of located patients enrolled | Differences between participants and non-participants will be examined annually, in terms of demographic (age, sex, ethnicity) and clinical characteristics (primary diagnosis, therapeutic protocol, time since diagnosis, treating institution). | Up to 20 years | 
| Collection of protocol-specific outcome data | Methods of statistical analysis to be used are those appropriate for analysis of cohort studies. Poisson regression (piece-wise exponential models) and Cox regression will be the primary methods of risk-factor analysis. When comparing study cohort with national rates, Poisson regression will be used. When the comparison is internal (ie, no use of national standard rates), Cox regression will be used. | Up to 20 years | 
| Collection of cumulative therapeutic exposure data |  | Up to 20 years |