NCT00807768 · OUTCOME

Patient Reported Fatigue

Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer · Source last updated 2019-03-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: LEAST_SQUARES_MEAN
Unit: units on a scale
Interval / dispersion: Standard Error
Time frame: Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment

What was measured

Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggests less fatigue.

Analysis population: Provided baseline and \>= follow-up assessments

Groups in this outcome

Arm I (Pelvic Radiation Therapy)

Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

Arm II (Brachytherapy, Paclitaxel, Carboplatin)

Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Arm I (Pelvic Radiation Therapy)	263
Arm II (Brachytherapy, Paclitaxel, Carboplatin)	277

Reported measurements

Baseline

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Arm I (Pelvic Radiation Therapy)	40.5	0.6	Not reported	Not reported	Not reported
Arm II (Brachytherapy, Paclitaxel, Carboplatin)	41.2	0.6	Not reported	Not reported	Not reported

4 Weeks

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Arm I (Pelvic Radiation Therapy)	35.8	0.7	Not reported	Not reported	Not reported
Arm II (Brachytherapy, Paclitaxel, Carboplatin)	35.8	0.6	Not reported	Not reported	Not reported

10-11 Weeks

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Arm I (Pelvic Radiation Therapy)	40.5	0.6	Not reported	Not reported	Not reported
Arm II (Brachytherapy, Paclitaxel, Carboplatin)	36.8	0.7	Not reported	Not reported	Not reported

8 Months

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Arm I (Pelvic Radiation Therapy)	42.1	0.5	Not reported	Not reported	Not reported
Arm II (Brachytherapy, Paclitaxel, Carboplatin)	40.3	0.6	Not reported	Not reported	Not reported

14 Months

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Arm I (Pelvic Radiation Therapy)	40.9	0.6	Not reported	Not reported	Not reported
Arm II (Brachytherapy, Paclitaxel, Carboplatin)	41.1	0.6	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.6
value
40.5
group Id
OG001
spread
0.6
value
41.2
title
Baseline
categories
measurements
group Id
OG000
spread
0.7
value
35.8
group Id
OG001
spread
0.6
value
35.8
title
4 Weeks
categories
measurements
group Id
OG000
spread
0.6
value
40.5
group Id
OG001
spread
0.7
value
36.8
title
10-11 Weeks
categories
measurements
group Id
OG000
spread
0.5
value
42.1
group Id
OG001
spread
0.6
value
40.3
title
8 Months
categories
measurements
group Id
OG000
spread
0.6
value
40.9
group Id
OG001
spread
0.6
value
41.1
title
14 Months

denoms

counts
group Id
OG000
value
263
group Id
OG001
value
277
units
Participants

description

dispersion Type

Standard Error

groups

description
Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
id
OG000
title
Arm I (Pelvic Radiation Therapy)
description
Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
id
OG001
title
Arm II (Brachytherapy, Paclitaxel, Carboplatin)

param Type

LEAST_SQUARES_MEAN

population Description

Provided baseline and \>= follow-up assessments

reporting Status

POSTED

time Frame

Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment

title

Patient Reported Fatigue

type

SECONDARY

unit Of Measure

units on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice