Our primary goal is to assess only relevant endpoints that have tangible outcomes for cancer patients and clinical practice. Over the previous grant period, QOL research has been organized into a programmatic approach following three themes: 1) assessing QOL endpoints efficiently within treatment trials; 2) designing trials targeted specifically to QOL endpoints; and 3) developing new QOL methodology. Cancer treatment delivery can be improved through direct intervention to impact QOL endpoints, improved QOL assessment methods, or interventions to ameliorate concomitant side effects. A barrier to the development of these research efforts has been the lack of dedicated resources. Preliminary Work: A guiding principle of our preliminary work can be summarized as """"""""less is more"""""""". We demonstrated that a single item global QOL instrument can display greater sensitivity to change than a multi- tem tool aimed at the same construct. We use minimally sufficient sets of individual QOL items and a prior clinically significant effect sizes. Preliminary Work: A guiding principle of our preliminary work can be summarized as """"""""less is more."""""""" We demonstrated that a single item global QOL instrument can display greater sensitivity to change than a multi- item tool aimed at the same construct. We use minimally sufficient sets of individual QOL items and a priori clinically significant effect sizes. Clinical trials work includes pilot studies that target QOL endpoints (such social support) which impact directly on the ability to receive and tolerate cancer treatments and special populations (e.g., the elderly). Methodological advances include new tools, approaches, and analytical methods for combining QOL data with the traditional treatment endpoints of survival and response. This work also impacts the design of and accrual to cancer treatment trials. Future Directions: We have identified major issues for QOL research which will be addressed across all disease committees. We will define clinical significance for QOL endpoints by hosting an international meeting with the purpose of drafting a consensus document. Other research targets the use of individual questions as clinical intervention triggers and the use of proxy respondents to address the issue of missing data. We will construct an assessment package to identify frail elderly cancer patients so that modified treatments can be developed and linkage programs established within the community oncology practices to address deficits in individual patient social support. We will also explore the use of complementary therapies for pain management, including music and massage. Summary: The unique community practice-based structure of NCCTG has fostered the development of efficient, programmatic, and pragmatic, and pragmatic QOL research. We are at a critical juncture whereupon the present activity can be grown into a fully funded and functional program.
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