Hematopoietic Cell Transplantation Recipient, Leukemia, Solid Tumor
Conditions
Brief 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.
Interventions
PROCEDUREAssessment of Therapy Complications
Complete patient response form and Health Status Update Form
OTHERQuestionnaire Administration
Complete patient response form, Health Status Update Form (called the "Keep in Touch" form), and Quality of Life Questionnaire (PROMIS)
Sponsors
Children's Oncology Group
National Cancer Institute (NCI)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| Collection of protocol-specific outcome data | 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. |
| Collection of cumulative therapeutic exposure data | Up to 20 years | — |
Countries
Puerto Rico, United States
Contacts
PRINCIPAL_INVESTIGATORSmita Bhatia
Children's Oncology Group
Outcome results
None listed