Umbrella Long-Term Follow-Up Protocol
概览
- 阶段
- 不适用
- 干预措施
- Assessment of Therapy Complications
- 疾病 / 适应症
- Hematopoietic Cell Transplantation Recipient
- 发起方
- Children's Oncology Group
- 入组人数
- 5000
- 试验地点
- 277
- 主要终点
- Collection of cumulative therapeutic exposure data
- 状态
- 进行中（未招募）
- 最后更新
- 26天前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Observational (long-term follow-up)
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
干预措施: Assessment of Therapy Complications
Observational (long-term follow-up)
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
干预措施: Questionnaire Administration
结局指标
主要结局
Collection of cumulative therapeutic exposure data
时间窗: Up to 20 years
Collection of protocol-specific outcome data
时间窗: 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 patients in which long-term (20+ years) contact is maintained
时间窗: Up to 20 years
Percentage of patients enrolled
时间窗: Up to 20 years
Percentage of located patients enrolled
时间窗: 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 eligible patients located who were lost to follow-up
时间窗: Up to 20 years