Trial Outcomes & Findings for Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine (NCT NCT03596918)
NCT ID: NCT03596918
Last Updated: 2026-02-11
Results Overview
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. The overall score is the sum of all the subscales and ranges from 0 to 108. Higher scores reflect better quality of life outcomes. The FACT-G Total Score at 3 months is reported here
COMPLETED
10 participants
Up to 3 months after treatment completion
2026-02-11
Participant Flow
Participant milestones
| Measure |
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.
Bleomycin Sulfate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Vincristine Sulfate: Given IV
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine
Baseline characteristics by cohort
| Measure |
Supportive Care (Vincristine Sulfate, Bleomycin Sulfate)
n=10 Participants
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.
Bleomycin Sulfate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Vincristine Sulfate: Given IV
|
|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 16.4 • n=41 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
Tanzania
|
10 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months after treatment completionThe 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. The overall score is the sum of all the subscales and ranges from 0 to 108. Higher scores reflect better quality of life outcomes. The FACT-G Total Score at 3 months is reported here
Outcome measures
| Measure |
Supportive Care (Vincristine Sulfate, Bleomycin Sulfate)
n=10 Participants
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.
Bleomycin Sulfate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Vincristine Sulfate: Given IV
|
|---|---|
|
Total Score on Quality of Life Assessed Using Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire
|
56.9 score on a scale
Standard Deviation 11.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearLongitudinal Quality of Life Study Among Participants with AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania
Outcome measures
Outcome data not reported
Adverse Events
Supportive Care (Vincristine Sulfate, Bleomycin Sulfate)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeannette Y. Lee
AMC Statistical and Data Analysis Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place