ID

35672

Descripción

Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Palabras clave

Versiones (1)
  1. 15/3/19 15/3/19 -
Titular de derechos de autor

GSK group of companies

Subido en

15 de marzo de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369

Inglés

Quality of Life

1 formularios  
  1. StudyEvent: ODM
    1. Quality of Life
Administrative data
Descripción

Administrative data

Name
Descripción

Name

Tipo de datos

text

Today's Date
Descripción

Date

Tipo de datos

date

Protocol Number
Descripción

Protocol Number

Tipo de datos

integer

Physical well-being
Descripción

Physical well-being

I have a lack of energy
Descripción

lack of energy

Tipo de datos

text

I have nausea
Descripción

nausea

Tipo de datos

text

Because of my physical condition, I have trouble meeting the needs of my family
Descripción

Trouble meeting family needs

Tipo de datos

text

I have pain
Descripción

Pain

Tipo de datos

text

I am bothered by side effects of treatment
Descripción

side effects of treatment

Tipo de datos

text

I feel ill
Descripción

feeling ill

Tipo de datos

text

I am forced to spend time in bed
Descripción

bed rest

Tipo de datos

text

Social/Family Well-Being
Descripción

Social/Family Well-Being

I feel close to my friends
Descripción

closeness to friends

Tipo de datos

text

I get emotional support from my family
Descripción

family emotional support

Tipo de datos

text

I get support from my friends and neighbors
Descripción

Support from friends and neighbours

Tipo de datos

text

My family has accepted my illness
Descripción

illness acceptance by family

Tipo de datos

text

I am satisfied with family communication about my illness
Descripción

family communication about illness

Tipo de datos

text

I feel close to my partner (or the person who is my main support)
Descripción

closeness to main supporting family member

Tipo de datos

text

I am satisfied with my sex life
Descripción

If you prefer not to answer this question, just skip it and go to the next section.

Tipo de datos

text

Emotional Well-Being
Descripción

Emotional Well-Being

I feel sad
Descripción

feeling sad

Tipo de datos

text

I am satisfied with how I am coping with my illness
Descripción

satisfactory coping with illness

Tipo de datos

text

I am loosing hope in the fight against my illness
Descripción

loss of hope

Tipo de datos

text

I feel nervous
Descripción

feeling nervous

Tipo de datos

text

I worry about dying
Descripción

fear of death

Tipo de datos

text

I worry that my condition will get worse
Descripción

worry about worsening condition

Tipo de datos

text

Functional Well-Being
Descripción

Functional Well-Being

I am able to work (include work at home)
Descripción

ability to work

Tipo de datos

text

my work (include work a home) is fulfilling
Descripción

work is fulfilling

Tipo de datos

text

I am able to enjoy life
Descripción

able to enjoy life

Tipo de datos

text

I have accepted my illness
Descripción

acceptance of illness

Tipo de datos

text

I am sleeping well
Descripción

sleep

Tipo de datos

text

I am enjoying things I usually do for fun
Descripción

enjoying leisure activities

Tipo de datos

text

I am content with the quality of my life right now
Descripción

content with life quality

Tipo de datos

text

Please rate your overall quality of life
Descripción

lowest quality 0 highest quality 100

Tipo de datos

integer

Additional Concerns
Descripción

Additional Concerns

I am bothered by discharge or bleeding from my vagina
Descripción

vaginal bleeding

Tipo de datos

text

I am bothered by odor coming from my vagina
Descripción

vaginal odor

Tipo de datos

text

I am afraid to have sex
Descripción

fear of sexual contact

Tipo de datos

text

I feel sexually attractive
Descripción

sexual attractiveness

Tipo de datos

text

My vagina feels too narrow or short
Descripción

vagina narrow

Tipo de datos

text

I have concerns about my ability to have children
Descripción

concern about child bearing potential

Tipo de datos

text

I am afraid the treatment may harm my body
Descripción

fear of treatment harm

Tipo de datos

text

I am interested in having sex
Descripción

interest in sex

Tipo de datos

text

I like the appearance of my body
Descripción

body dissatisfaction

Tipo de datos

text

I am bothered by constipation
Descripción

constipation

Tipo de datos

text

I have a good appetite
Descripción

appetite

Tipo de datos

text

I have trouble controlling my urine
Descripción

urine control

Tipo de datos

text

It burns when I urinate
Descripción

burning while urinating

Tipo de datos

text

I have discomfort when I urinate
Descripción

discomfort while urinating

Tipo de datos

text

I am able to eat the foods that I like
Descripción

dietary preferences

Tipo de datos

text

I have numbness or tingling in my hands
Descripción

numbness / tingling hands

Tipo de datos

text

I have numbness or tingling in my feet
Descripción

numbness / tingling feet

Tipo de datos

text

I have joint pain or muscle cramps
Descripción

joint pain / muscle cramps

Tipo de datos

text

I feel weak all over
Descripción

weakness

Tipo de datos

text

I have trouble hearing
Descripción

hearing problems

Tipo de datos

text

I get a ringing or buzzing in my ears
Descripción

ringing / buzzing ears

Tipo de datos

text

I have trouble buttoning buttons
Descripción

hand coordination

Tipo de datos

text

I have trouble feeling the shape of small objects when they are in my hand
Descripción

Hypoaesthesia

Tipo de datos

text

I have trouble walking
Descripción

Paraparesis

Tipo de datos

text

Brief Pain Inventory
Descripción

Brief Pain Inventory

Brief Pain Inventory
Descripción

Brief Pain Inventory

Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst on the average)
Descripción

Brief Pain Inventory

Tipo de datos

float

Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst right now)
Descripción

Brief Pain Inventory

Tipo de datos

float

What treatments or medications are you receiving for your pain?
Descripción

painkillers and treatment

Tipo de datos

text

In the last 24 hours how much relief have pain medications provided?
Descripción

Please mark the one percentage that most shows how much relief you have received

Tipo de datos

integer

Unidades de medida
  • %
%
Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst in the last 24 hours)
Descripción

(No pain - 0; Pain as bad as you can imagine - 10)

Tipo de datos

float

Pain Interference
Descripción

Pain Interference

Mark how during the past 24 hours pain has interfered with your:
Descripción

choose type of activity

Tipo de datos

text

Interference scale
Descripción

1 - does not interfere 10 - completely interferes

Tipo de datos

text

Volver a la parte superior de la página

Similar models

Quality of Life

1 formularios
  1. StudyEvent: ODM
    1. Quality of Life
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Name
Item
Name
text
Date
Item
Today's Date
date
Protocol Number
Item
Protocol Number
integer
Item Group
Physical well-being
Item
I have a lack of energy
text
lack of energy
Code List
I have a lack of energy
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have nausea
text
nausea
Code List
I have nausea
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
Because of my physical condition, I have trouble meeting the needs of my family
text
Trouble meeting family need
Code List
Because of my physical condition, I have trouble meeting the needs of my family
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have pain
text
Pain
Code List
I have pain
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am bothered by side effects of treatment
text
side effects of treatment
Code List
I am bothered by side effects of treatment
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel ill
text
feeling ill
Code List
I feel ill
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am forced to spend time in bed
text
bed rest
Code List
I am forced to spend time in bed
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel close to my friends
text
closeness to friends
Code List
I feel close to my friends
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I get emotional support from my family
text
family emotional support
Code List
I get emotional support from my family
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I get support from my friends and neighbors
text
Support from friends and neighbours
Code List
I get support from my friends and neighbors
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
My family has accepted my illness
text
illness acceptance by family
Code List
My family has accepted my illness
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am satisfied with family communication about my illness
text
family communication about illness
Code List
I am satisfied with family communication about my illness
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel close to my partner (or the person who is my main support)
text
closeness to main supporting family member
Code List
I feel close to my partner (or the person who is my main support)
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am satisfied with my sex life
text
satisfaction with current sexual acitivity
Code List
I am satisfied with my sex life
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item Group
Emotional Well-Being
Item
I feel sad
text
feeling sad
Code List
I feel sad
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am satisfied with how I am coping with my illness
text
satisfactory coping with illness
Code List
I am satisfied with how I am coping with my illness
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am loosing hope in the fight against my illness
text
loss of hope
Code List
I am loosing hope in the fight against my illness
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel nervous
text
feeling nervous
Code List
I feel nervous
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I worry about dying
text
fear of death
Code List
I worry about dying
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I worry that my condition will get worse
text
worry about worsening condition
Code List
I worry that my condition will get worse
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item Group
Functional Well-Being
Item
I am able to work (include work at home)
text
ability to work
Code List
I am able to work (include work at home)
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
my work (include work a home) is fulfilling
text
work is fulfilling
Code List
my work (include work a home) is fulfilling
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am able to enjoy life
text
able to enjoy life
Code List
I am able to enjoy life
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have accepted my illness
text
acceptance of illness
Code List
I have accepted my illness
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am sleeping well
text
sleep
Code List
I am sleeping well
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am enjoying things I usually do for fun
text
enjoying leisure activities
Code List
I am enjoying things I usually do for fun
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am content with the quality of my life right now
text
content with life quality
Code List
I am content with the quality of my life right now
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
overall quality of life
Item
Please rate your overall quality of life
integer
Item Group
Additional Concerns
Item
I am bothered by discharge or bleeding from my vagina
text
vaginal bleeding
Code List
I am bothered by discharge or bleeding from my vagina
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am bothered by odor coming from my vagina
text
vaginal odor
Code List
I am bothered by odor coming from my vagina
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am afraid to have sex
text
fear of sexual contact
Code List
I am afraid to have sex
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel sexually attractive
text
sexual attractiveness
Code List
I feel sexually attractive
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
My vagina feels too narrow or short
text
vagina narrow
Code List
My vagina feels too narrow or short
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have concerns about my ability to have children
text
concern about child bearing potential
Code List
I have concerns about my ability to have children
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am afraid the treatment may harm my body
text
fear of treatment harm
Code List
I am afraid the treatment may harm my body
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am interested in having sex
text
interest in sex
Code List
I am interested in having sex
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I like the appearance of my body
text
body dissatisfaction
Code List
I like the appearance of my body
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am bothered by constipation
text
constipation
Code List
I am bothered by constipation
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have a good appetite
text
appetite
Code List
I have a good appetite
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have trouble controlling my urine
text
urine control
Code List
I have trouble controlling my urine
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
It burns when I urinate
text
burning while urinating
Code List
It burns when I urinate
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have discomfort when I urinate
text
discomfort while urinating
Code List
I have discomfort when I urinate
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am able to eat the foods that I like
text
dietary preferences
Code List
I am able to eat the foods that I like
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have numbness or tingling in my hands
text
numbness / tingling hands
Code List
I have numbness or tingling in my hands
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have numbness or tingling in my feet
text
numbness / tingling feet
Code List
I have numbness or tingling in my feet
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have joint pain or muscle cramps
text
joint pain / muscle cramps
Code List
I have joint pain or muscle cramps
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel weak all over
text
weakness
Code List
I feel weak all over
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have trouble hearing
text
hearing problems
Code List
I have trouble hearing
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I get a ringing or buzzing in my ears
text
ringing / buzzing ears
Code List
I get a ringing or buzzing in my ears
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have trouble buttoning buttons
text
hand coordination
Code List
I have trouble buttoning buttons
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have trouble feeling the shape of small objects when they are in my hand
text
Hypoaesthesia
Code List
I have trouble feeling the shape of small objects when they are in my hand
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have trouble walking
text
Paraparesis
Code List
I have trouble walking
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item Group
Brief Pain Inventory
Item Group
Brief Pain Inventory
Brief Pain Inventory
Item
Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst on the average)
float
Brief Pain Inventory
Item
Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst right now)
float
painkillers and treatment
Item
What treatments or medications are you receiving for your pain?
text
pain relief
Item
In the last 24 hours how much relief have pain medications provided?
integer
Brief Pain Inventory
Item
Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst in the last 24 hours)
float
Item Group
Pain Interference
Item
Mark how during the past 24 hours pain has interfered with your:
text
Pain interference
Code List
Mark how during the past 24 hours pain has interfered with your:
CL Item
general activity (1)
CL Item
mood (2)
CL Item
walking ability (includes both work outside the home and housework) (3)
CL Item
normal work (4)
CL Item
relationships with other people (5)
CL Item
sleep (6)
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