Grant Number:	5R01CA078960-04 Interpret this number
Primary Investigator:	Nicholson, Henry
Organization:	Oregon Health And Science University
Project Title:	Quality of Life Following Successful Therapy of Aml
Fiscal Year:	2001

DESCRIPTION: (Applicant's Description) Bone marrow transplanation (BMT) has been the most effective therapy for children and adolescents with acute myelogenous leukemia (AML) treated on Children's Cancer Group (CCG) clinical trials and, at CCG institutions, has become the standard of care for children with matched sibling donors. Whether BMT is indeed the standard of care for AML remains controversial, and BMT has not been accepted as the standard of care by the entire pediatric oncology community. Also, BMT may have late effects of therapy that adversely affect the quality of life (QOL) experienced by survivors. If BMT is associated with significant negative effects on the survivors' QOL, then the recommendations for BMT may need modification. Therefore, the applicant proposes a study of QOL in AML survivors. The specific aims of this study are: 1) to measure the QOL, as defined by multidimensional instruments surveying several important domains in survivors of AML; 2) to determine the impact of initial therapy (either BMT or chemotherapy) on the QOL in survivors of AML; 3) to determine whether survivors' demographic characteristics (such as age at diagnosis; sex and/or race) and treatment complications (such as graft versus host disease) are associated with the QOL outcome; 4) to determine whether specific late effects of therapy are associated with diminished QOL in survivors; and 5) to define the areas in both physical and psychological domains where interventions may be undertaken to improve QOL in survivors of AML. QOL and the frequency of late effects will be measured in an estimated 488 AML survivors who were treated on four sequential CCG AML protocols, including 160 treated with allogeneic BMT (allo-BMT), 72 treated with autologous BMT (auto-BMT), and 256 treated with chemotherapy (chemo). Participants will complete a telephone interview; QOL will be measured using the Medical Outcomes Study Short-Form 36 (MOS SF-36) instrument, and late effects will be measured using questionnaires from the Childhood Cancer Survivor Study (CCSS). In addition, self-concept, mood disturbances, and risk-taking behaviors will be measured using the Harter Profile of Mood States (POMS) and the CDC Youth Risk Behavior Survey, respectively. The QOL outcomes will be examined for associations with treatment variables (allo-BMT versus chemo; allo-BMT versus auto-BMT; auto-BMT versus chemo), with survivors' characteristics (sex, race, age at diagnosis, etc.) and with the late effects outcomes. Successful completion of this study will help the pediatric oncology community decrease the suffering associated with pediatric and adolescent AML in the following ways: 1) It will influence clinical trial design in order to optimize QOL. 2) Parents and caregivers will be able to make better decisions about therapy by taking QOL concerns into account. 3) Interventions can be designed which will lessen the impact of late complications of therapy on the QOL experienced by survivors. Completion of this study should help pediatric oncologists fight AML in ways that optimize both survival and QOL.





None