Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine
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|ClinicalTrials.gov Identifier: NCT03596918|
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|AIDS-Related Kaposi Sarcoma Human Immunodeficiency Virus 1 Positive||Biological: Bleomycin Sulfate Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Vincristine Sulfate||Phase 1|
I. To evaluate the longitudinal quality of life of participants with human immunodeficiency virus (HIV)-associated Kaposi sarcoma (KS) during treatment with bleomycin sulfate (bleomycin) and vincristine sulfate (vincristine) at a single institution in East Africa.
II. To explore baseline and time-dependent correlates of improvements in quality of life (QOL).
III. To assess quality control (completeness and accuracy) in data capture of adverse events, clinical benefit, and objective response for site evaluation and training purposes.
Patients receive vincristine intravenously (IV) over 1-2 minutes and bleomycin IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Longitudinal Quality of Life Study Among Participants With AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania|
|Actual Study Start Date :||October 10, 2018|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: Supportive care (vincristine sulfate, bleomycin sulfate)
Patients receive vincristine sulfate IV over 1-2 minutes and bleomycin sulfate IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Biological: Bleomycin Sulfate
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Drug: Vincristine Sulfate
- Quality of life assessed using Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire [ Time Frame: Up to 3 months after treatment completion ]The four domains of the FACT-G questionnaire will be determined for each questionnaire: physical well-being, social/family well-being, emotional well-being, and functional well-being. Each of these four domains is scored on a subset of 6-7 statements with a 0-4 scale. The domain is scored by summing up the responses to these statements. The ranges for the domains are as follows: physical well-being 0-28, social/family well-being 0-28, emotional well-being 0-24, and functional well-being 0-28. Using general estimating equations, changes in these domains with time will be explored. Logistic regression analyses will be used to correlate changes in quality of life domains with clinical response.
- Clinical data collection quality for site evaluation and training purposes [ Time Frame: Up to 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596918
|Bugando Medical Centre||Recruiting|
|Contact: Nestory Masalu 255-783-0-00004 email@example.com|
|Principal Investigator: Nestory Masalu, MD MMed|
|Study Chair:||Kristin Schroeder||AIDS Malignancy Consortium|
|Study Chair:||Nestory Masalu||Bugando Medical Centre|