NCT00736749

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

Umbrella Long-Term Follow-Up Protocol

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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 quality of life and 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 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, secure online form, or 24-hour toll-free telephone number. After initial contact, the LTFC will contact the patient annually.

Conditions

• Hematopoietic Cell Transplantation Recipient
• Leukemia
• Solid Tumor

Interventions

Type	Name	Description
PROCEDURE	Assessment of Therapy Complications	Complete patient response form and Health Status Update Form
OTHER	Questionnaire Administration	Complete patient response form, Health Status Update Form (called the "Keep in Touch" form), and Quality of Life Questionnaire (PROMIS)

Timeline

• Start date: 2008-07-17
• Primary completion: 2100-01-31
• First posted: 2008-08-18
• Last updated: 2026-04-06

Locations

164 sites across 2 countries: United States, Puerto Rico