Pilot Web-based Study of Functional Status, Symptom Palliation and Quality of Life Benefits Associated With Darbepoetin Alfa (Aranesp®) Administration in Anemic Patients With Cancer.
Anemia associated with lung cancer and chemotherapy is an important factor effecting patient
symptoms, functional status, and overall quality of life (Groopman and Itri 1999; Langer,
Choy et al. 2002). Darbepoetin alfa (Aranesp®) has demonstrated a significant effect upon
ameliorating chemotherapy-induced anemia in lung cancer (Vansteenkiste, Pirker et al. 2002;
Vansteenkiste, Poulsen et al. 2002). This trial is designed to evaluate the association
between the treatment of anemia with darbepoetin alfa and direct electronic capture of
clinical benefits in cancer-related symptoms, functional status and overall quality of life.
This trial uses a secure web-based design to capture the patient-associated symptoms,
functional status and quality of life. This novel secure web-based system was selected to
improve the efficiency and quality of clinical data capture. If our hypothesis is correct,
treatment with darbepoetin alfa will be associated with improved palliation of
cancer-related symptoms, improved functional status, and result in overall benefits to the
patient's health-related quality of life. The development of a web-based system to directly
capture patient-related symptoms, functional status and quality of life will permit us in
the future to conduct a national or international trial addressing the effects of
darbepoetin alfa on these factors. If our hypothesis is incorrect, it may be that these
parameters are not affected by the correction of anemia with darbepoetin alfa or the
measures are not sensitive enough to detect these differences. A notable finding would be a
clearly defined improvement in symptom palliation, functional status, and quality of life
associated with darbepoetin alfa therapy.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
A secure web-based assessment of cancer-related symptoms (LCSS), functional status (SF-36), and quality of life (FACT-An and PFS) will be obtained every 2 weeks (weeks 3, 5, 7, 9, 11, and 13).
every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)
James R Rigas, MD
Norris Cotton Cancer Center
United States: Institutional Review Board
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|