Trial Outcomes & Findings for Fatigue in Emergency Center Patients (NCT NCT00504985)

Results Overview

Descriptive factor and cluster analysis using MD Anderson Symptom Index (MDASI) 13 core symptom items to form 1) treatment-related factor (nausea and vomiting) and 2) general severity factor (the remaining 11 core symptom items). Patients rate intensity and interference of symptoms on 0-10 numeric scales from "not present" to "as bad as you can imagine." Patients also rate the amount of interference with daily activities caused by symptoms on 0-10 numeric scales from "did not interfere" to "interfered completely."

Recruitment status

TERMINATED

Target enrollment

14 participants

Primary outcome timeframe

Survey and blood draw done within 24 hours of patient's Emergency Center visit

Results posted on

2012-08-01

Participant Flow

Recruitment Period: 07/19/06 through 10/18/06. All participants recruited at UT MD Anderson Cancer Center.

Study terminated early due to low accrual.

Participant milestones

Participant milestones
Measure	Fatigue in Emergency Center Patients
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fatigue in Emergency Center Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fatigue in Emergency Center Patients n=14 Participants
Age Continuous	66 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Survey and blood draw done within 24 hours of patient's Emergency Center visit

Population: Study terminated early due to low recruitment, insufficient data for analysis.

Descriptive factor and cluster analysis using MD Anderson Symptom Index (MDASI) 13 core symptom items to form 1) treatment-related factor (nausea and vomiting) and 2) general severity factor (the remaining 11 core symptom items). Patients rate intensity and interference of symptoms on 0-10 numeric scales from "not present" to "as bad as you can imagine." Patients also rate the amount of interference with daily activities caused by symptoms on 0-10 numeric scales from "did not interfere" to "interfered completely."

Outcome measures

Outcome data not reported

Adverse Events

Fatigue in Emergency Center Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Xin Shelley Wang, MD, MPH / Associate Professor

UT MD Anderson Cancer Center

Phone: 713-745-3504

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place