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.
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