ID

35672

Descrizione

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 

Keywords

  1. 15/03/19 15/03/19 -
Titolare del copyright

GSK group of companies

Caricato su

15 marzo 2019

DOI

Per favore, per richiedere un accesso.

Licenza

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
Descrizione

Administrative data

Name
Descrizione

Name

Tipo di dati

text

Today's Date
Descrizione

Date

Tipo di dati

date

Protocol Number
Descrizione

Protocol Number

Tipo di dati

integer

Physical well-being
Descrizione

Physical well-being

I have a lack of energy
Descrizione

lack of energy

Tipo di dati

text

I have nausea
Descrizione

nausea

Tipo di dati

text

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

Trouble meeting family needs

Tipo di dati

text

I have pain
Descrizione

Pain

Tipo di dati

text

I am bothered by side effects of treatment
Descrizione

side effects of treatment

Tipo di dati

text

I feel ill
Descrizione

feeling ill

Tipo di dati

text

I am forced to spend time in bed
Descrizione

bed rest

Tipo di dati

text

Social/Family Well-Being
Descrizione

Social/Family Well-Being

I feel close to my friends
Descrizione

closeness to friends

Tipo di dati

text

I get emotional support from my family
Descrizione

family emotional support

Tipo di dati

text

I get support from my friends and neighbors
Descrizione

Support from friends and neighbours

Tipo di dati

text

My family has accepted my illness
Descrizione

illness acceptance by family

Tipo di dati

text

I am satisfied with family communication about my illness
Descrizione

family communication about illness

Tipo di dati

text

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

closeness to main supporting family member

Tipo di dati

text

I am satisfied with my sex life
Descrizione

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

Tipo di dati

text

Emotional Well-Being
Descrizione

Emotional Well-Being

I feel sad
Descrizione

feeling sad

Tipo di dati

text

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

satisfactory coping with illness

Tipo di dati

text

I am loosing hope in the fight against my illness
Descrizione

loss of hope

Tipo di dati

text

I feel nervous
Descrizione

feeling nervous

Tipo di dati

text

I worry about dying
Descrizione

fear of death

Tipo di dati

text

I worry that my condition will get worse
Descrizione

worry about worsening condition

Tipo di dati

text

Functional Well-Being
Descrizione

Functional Well-Being

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

ability to work

Tipo di dati

text

my work (include work a home) is fulfilling
Descrizione

work is fulfilling

Tipo di dati

text

I am able to enjoy life
Descrizione

able to enjoy life

Tipo di dati

text

I have accepted my illness
Descrizione

acceptance of illness

Tipo di dati

text

I am sleeping well
Descrizione

sleep

Tipo di dati

text

I am enjoying things I usually do for fun
Descrizione

enjoying leisure activities

Tipo di dati

text

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

content with life quality

Tipo di dati

text

Please rate your overall quality of life
Descrizione

lowest quality 0 highest quality 100

Tipo di dati

integer

Additional Concerns
Descrizione

Additional Concerns

I am bothered by discharge or bleeding from my vagina
Descrizione

vaginal bleeding

Tipo di dati

text

I am bothered by odor coming from my vagina
Descrizione

vaginal odor

Tipo di dati

text

I am afraid to have sex
Descrizione

fear of sexual contact

Tipo di dati

text

I feel sexually attractive
Descrizione

sexual attractiveness

Tipo di dati

text

My vagina feels too narrow or short
Descrizione

vagina narrow

Tipo di dati

text

I have concerns about my ability to have children
Descrizione

concern about child bearing potential

Tipo di dati

text

I am afraid the treatment may harm my body
Descrizione

fear of treatment harm

Tipo di dati

text

I am interested in having sex
Descrizione

interest in sex

Tipo di dati

text

I like the appearance of my body
Descrizione

body dissatisfaction

Tipo di dati

text

I am bothered by constipation
Descrizione

constipation

Tipo di dati

text

I have a good appetite
Descrizione

appetite

Tipo di dati

text

I have trouble controlling my urine
Descrizione

urine control

Tipo di dati

text

It burns when I urinate
Descrizione

burning while urinating

Tipo di dati

text

I have discomfort when I urinate
Descrizione

discomfort while urinating

Tipo di dati

text

I am able to eat the foods that I like
Descrizione

dietary preferences

Tipo di dati

text

I have numbness or tingling in my hands
Descrizione

numbness / tingling hands

Tipo di dati

text

I have numbness or tingling in my feet
Descrizione

numbness / tingling feet

Tipo di dati

text

I have joint pain or muscle cramps
Descrizione

joint pain / muscle cramps

Tipo di dati

text

I feel weak all over
Descrizione

weakness

Tipo di dati

text

I have trouble hearing
Descrizione

hearing problems

Tipo di dati

text

I get a ringing or buzzing in my ears
Descrizione

ringing / buzzing ears

Tipo di dati

text

I have trouble buttoning buttons
Descrizione

hand coordination

Tipo di dati

text

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

Hypoaesthesia

Tipo di dati

text

I have trouble walking
Descrizione

Paraparesis

Tipo di dati

text

Brief Pain Inventory
Descrizione

Brief Pain Inventory

Brief Pain Inventory
Descrizione

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)
Descrizione

Brief Pain Inventory

Tipo di dati

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)
Descrizione

Brief Pain Inventory

Tipo di dati

float

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

painkillers and treatment

Tipo di dati

text

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

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

Tipo di dati

integer

Unità di misura
  • %
%
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)
Descrizione

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

Tipo di dati

float

Pain Interference
Descrizione

Pain Interference

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

choose type of activity

Tipo di dati

text

Interference scale
Descrizione

1 - does not interfere 10 - completely interferes

Tipo di dati

text

Similar models

Quality of Life

  1. StudyEvent: ODM
    1. Quality of Life
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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