NCT02126969 · OUTCOME

Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.

A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN · Source last updated 2023-03-13

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

Measure: MEAN
Unit: change in score
Interval / dispersion: Standard Deviation
Time frame: Up to 50 days (pre- and post-treatment)

What was measured

Quality of Life (QOL) will be measured pre- and post-treatment using a single 5-question QOL well-being survey. The change in score will be presented independently for each subpart of the QOL survey. 1. Physical; scores range from 7-35; higher scores indicate increased well-being 2. Social/family; scores range from 7-35; higher scores indicate increased well-being 3. Emotional; scores range from 6-30; higher scores indicate increased well-being 4. Functional; scores range from 7-35; higher scores indicate increased well-being 5. Additional Concerns; scores range from 10-50; lower scores indicate increased well-being 6. FACT-G is the sum of the first 4 scores; scores range from 27-135; higher scores indicated increased well-being 7. FACT-H\&N is the sum of the first five scores; scores range from 37-185; higher scores indicated increased well-being 8. Trial Outcome Index is the sum of 1, 4 and 5; scores range from 24-120; higher scores indicated increased well-being

Groups in this outcome

Chemotherapy Plus Radiation Therapy

Low dose fractionated radiation - 80cGy with chemotherapy Low dose fractionated radiation - 80cGy with chemotherapy: Chemotherapy + 80 cGy of RT

Chemotherapy Without Radiation

Chemotherapy only Docetaxel and Carboplatin AUC 6: Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation

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
Chemotherapy Plus Radiation Therapy	22
Chemotherapy Without Radiation	20

Reported measurements

PHYSICAL WELL-BEING SCORE

Values in change in score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy Plus Radiation Therapy	-1.46	5.12	Not reported	Not reported	Not reported
Chemotherapy Without Radiation	-1.64	7.22	Not reported	Not reported	Not reported

SOCIAL/FAMILY WELL-BEING SCORE

Values in change in score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy Plus Radiation Therapy	-1.34	4.55	Not reported	Not reported	Not reported
Chemotherapy Without Radiation	-2.34	3.72	Not reported	Not reported	Not reported

EMOTIONAL WELL-BEING SCORE

Values in change in score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy Plus Radiation Therapy	2.05	3.75	Not reported	Not reported	Not reported
Chemotherapy Without Radiation	1.60	4.31	Not reported	Not reported	Not reported

FUNCTIONAL WELL-BEING SCORE

Values in change in score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy Plus Radiation Therapy	-0.48	6.04	Not reported	Not reported	Not reported
Chemotherapy Without Radiation	-1.70	4.92	Not reported	Not reported	Not reported

FACT-G TOTAL SCORE

Values in change in score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy Plus Radiation Therapy	-1.23	13.52	Not reported	Not reported	Not reported
Chemotherapy Without Radiation	-4.08	12.72	Not reported	Not reported	Not reported

ADDITIONAL CONCERNS SCORE

Values in change in score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy Plus Radiation Therapy	5.01	8.24	Not reported	Not reported	Not reported
Chemotherapy Without Radiation	3.63	7.80	Not reported	Not reported	Not reported

FACT-H&N TOTAL SCORE

Values in change in score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy Plus Radiation Therapy	3.79	18.05	Not reported	Not reported	Not reported
Chemotherapy Without Radiation	-0.46	19.16	Not reported	Not reported	Not reported

TRIAL OUTCOME INDEX SCORE

Values in change in score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy Plus Radiation Therapy	3.08	14.55	Not reported	Not reported	Not reported
Chemotherapy Without Radiation	0.29	15.05	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
5.12
value
-1.46
group Id
OG001
spread
7.22
value
-1.64
title
PHYSICAL WELL-BEING SCORE
categories
measurements
group Id
OG000
spread
4.55
value
-1.34
group Id
OG001
spread
3.72
value
-2.34
title
SOCIAL/FAMILY WELL-BEING SCORE
categories
measurements
group Id
OG000
spread
3.75
value
2.05
group Id
OG001
spread
4.31
value
1.60
title
EMOTIONAL WELL-BEING SCORE
categories
measurements
group Id
OG000
spread
6.04
value
-0.48
group Id
OG001
spread
4.92
value
-1.70
title
FUNCTIONAL WELL-BEING SCORE
categories
measurements
group Id
OG000
spread
13.52
value
-1.23
group Id
OG001
spread
12.72
value
-4.08
title
FACT-G TOTAL SCORE
categories
measurements
group Id
OG000
spread
8.24
value
5.01
group Id
OG001
spread
7.80
value
3.63
title
ADDITIONAL CONCERNS SCORE
categories
measurements
group Id
OG000
spread
18.05
value
3.79
group Id
OG001
spread
19.16
value
-0.46
title
FACT-H&N TOTAL SCORE
categories
measurements
group Id
OG000
spread
14.55
value
3.08
group Id
OG001
spread
15.05
value
0.29
title
TRIAL OUTCOME INDEX SCORE

denoms

counts
group Id
OG000
value
22
group Id
OG001
value
20
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Low dose fractionated radiation - 80cGy with chemotherapy Low dose fractionated radiation - 80cGy with chemotherapy: Chemotherapy + 80 cGy of RT
id
OG000
title
Chemotherapy Plus Radiation Therapy
description
Chemotherapy only Docetaxel and Carboplatin AUC 6: Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation
id
OG001
title
Chemotherapy Without Radiation

param Type

MEAN

reporting Status

POSTED

time Frame

Up to 50 days (pre- and post-treatment)

title

Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.

type

SECONDARY

unit Of Measure

change in score

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Preserved source evidence · Not medical advice