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35672

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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 

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Versioner (1)
  1. 2019-03-15 2019-03-15 -
Rättsinnehavare

GSK group of companies

Uppladdad den

15 mars 2019

DOI

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

    Engelsk

    Quality of Life

    1 Formulär  
    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

    Tillbaka till toppen

    Similar models

    Quality of Life

    1 Formulär
    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
    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)
    CL Item
    enjoyment of life (7)
    Interference scale
    Item
    Interference scale
    text
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