ID

35672

Beskrivning

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 

Nyckelord

  1. 2019-03-15 2019-03-15 -
Rättsinnehavare

GSK group of companies

Uppladdad den

15 mars 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369

Quality of Life

  1. StudyEvent: ODM
    1. Quality of Life
Administrative data
Beskrivning

Administrative data

Name
Beskrivning

Name

Datatyp

text

Today's Date
Beskrivning

Date

Datatyp

date

Protocol Number
Beskrivning

Protocol Number

Datatyp

integer

Physical well-being
Beskrivning

Physical well-being

I have a lack of energy
Beskrivning

lack of energy

Datatyp

text

I have nausea
Beskrivning

nausea

Datatyp

text

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

Trouble meeting family needs

Datatyp

text

I have pain
Beskrivning

Pain

Datatyp

text

I am bothered by side effects of treatment
Beskrivning

side effects of treatment

Datatyp

text

I feel ill
Beskrivning

feeling ill

Datatyp

text

I am forced to spend time in bed
Beskrivning

bed rest

Datatyp

text

Social/Family Well-Being
Beskrivning

Social/Family Well-Being

I feel close to my friends
Beskrivning

closeness to friends

Datatyp

text

I get emotional support from my family
Beskrivning

family emotional support

Datatyp

text

I get support from my friends and neighbors
Beskrivning

Support from friends and neighbours

Datatyp

text

My family has accepted my illness
Beskrivning

illness acceptance by family

Datatyp

text

I am satisfied with family communication about my illness
Beskrivning

family communication about illness

Datatyp

text

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

closeness to main supporting family member

Datatyp

text

I am satisfied with my sex life
Beskrivning

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

Datatyp

text

Emotional Well-Being
Beskrivning

Emotional Well-Being

I feel sad
Beskrivning

feeling sad

Datatyp

text

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

satisfactory coping with illness

Datatyp

text

I am loosing hope in the fight against my illness
Beskrivning

loss of hope

Datatyp

text

I feel nervous
Beskrivning

feeling nervous

Datatyp

text

I worry about dying
Beskrivning

fear of death

Datatyp

text

I worry that my condition will get worse
Beskrivning

worry about worsening condition

Datatyp

text

Functional Well-Being
Beskrivning

Functional Well-Being

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

ability to work

Datatyp

text

my work (include work a home) is fulfilling
Beskrivning

work is fulfilling

Datatyp

text

I am able to enjoy life
Beskrivning

able to enjoy life

Datatyp

text

I have accepted my illness
Beskrivning

acceptance of illness

Datatyp

text

I am sleeping well
Beskrivning

sleep

Datatyp

text

I am enjoying things I usually do for fun
Beskrivning

enjoying leisure activities

Datatyp

text

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

content with life quality

Datatyp

text

Please rate your overall quality of life
Beskrivning

lowest quality 0 highest quality 100

Datatyp

integer

Additional Concerns
Beskrivning

Additional Concerns

I am bothered by discharge or bleeding from my vagina
Beskrivning

vaginal bleeding

Datatyp

text

I am bothered by odor coming from my vagina
Beskrivning

vaginal odor

Datatyp

text

I am afraid to have sex
Beskrivning

fear of sexual contact

Datatyp

text

I feel sexually attractive
Beskrivning

sexual attractiveness

Datatyp

text

My vagina feels too narrow or short
Beskrivning

vagina narrow

Datatyp

text

I have concerns about my ability to have children
Beskrivning

concern about child bearing potential

Datatyp

text

I am afraid the treatment may harm my body
Beskrivning

fear of treatment harm

Datatyp

text

I am interested in having sex
Beskrivning

interest in sex

Datatyp

text

I like the appearance of my body
Beskrivning

body dissatisfaction

Datatyp

text

I am bothered by constipation
Beskrivning

constipation

Datatyp

text

I have a good appetite
Beskrivning

appetite

Datatyp

text

I have trouble controlling my urine
Beskrivning

urine control

Datatyp

text

It burns when I urinate
Beskrivning

burning while urinating

Datatyp

text

I have discomfort when I urinate
Beskrivning

discomfort while urinating

Datatyp

text

I am able to eat the foods that I like
Beskrivning

dietary preferences

Datatyp

text

I have numbness or tingling in my hands
Beskrivning

numbness / tingling hands

Datatyp

text

I have numbness or tingling in my feet
Beskrivning

numbness / tingling feet

Datatyp

text

I have joint pain or muscle cramps
Beskrivning

joint pain / muscle cramps

Datatyp

text

I feel weak all over
Beskrivning

weakness

Datatyp

text

I have trouble hearing
Beskrivning

hearing problems

Datatyp

text

I get a ringing or buzzing in my ears
Beskrivning

ringing / buzzing ears

Datatyp

text

I have trouble buttoning buttons
Beskrivning

hand coordination

Datatyp

text

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

Hypoaesthesia

Datatyp

text

I have trouble walking
Beskrivning

Paraparesis

Datatyp

text

Brief Pain Inventory
Beskrivning

Brief Pain Inventory

Brief Pain Inventory
Beskrivning

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)
Beskrivning

Brief Pain Inventory

Datatyp

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)
Beskrivning

Brief Pain Inventory

Datatyp

float

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

painkillers and treatment

Datatyp

text

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

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

Datatyp

integer

Måttenheter
  • %
%
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)
Beskrivning

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

Datatyp

float

Pain Interference
Beskrivning

Pain Interference

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

choose type of activity

Datatyp

text

Interference scale
Beskrivning

1 - does not interfere 10 - completely interferes

Datatyp

text

Similar models

Quality of Life

  1. StudyEvent: ODM
    1. Quality of Life
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
CL Item
enjoyment of life (7)
Interference scale
Item
Interference scale
text

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