Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153868
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2005-09-08
Brief Title:
A Web-based Study of Quality of Life Benefits Associated Aranesp in Anemic Patients With Cancer
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a web-based pilot study to evaluate the association between the treatment of anemia with darbepoetin alfa aranesp and the clinical benefits in symptom palliation improved functional status and quality of life in patients with cancer The feasibility of web-based assessments and data capture will be evaluated
Detailed Description:
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None