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

• Collection of cumulative therapeutic exposure data [ Time Frame: Up to 20 years ]
  
• Collection of protocol-specific outcome data [ Time Frame: Up to 20 years ]
  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.
  
  
• Percentage of eligible patients located who were lost to follow-up [ Time Frame: Up to 20 years ]
  
• Percentage of located patients enrolled [ Time Frame: Up to 20 years ]
  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).
  
  
• Percentage of patients enrolled [ Time Frame: Up to 20 years ]
  
• Percentage of patients in which long-term (20+ years) contact is maintained [ Time Frame: Up to 20 years ]
  

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 COG Late Effects Committee, the SDC, and the member institutions.

VI. To collect cumulative therapeutic exposure data (via therapeutic summaries completed online by treating institutions) on patients completing active therapy.

OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions.

Approximately 6 months after completion of therapy patients receive a mailed packet introducing the Long-Term Follow-Up Center (LTFC) and containing information related to their individualized, protocol-specific follow-up guidelines. Patients are asked to complete a patient response form, verify information provided in packet, update contact information, and complete a Health Status Update Form. 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 receive protocol-specific automatic reminders, and may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number.