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NCT04493333 · OUTCOME

Difference in Quality of Life on the Quality of Life - Cancer Survivor Version (QOL-CSV) From Baseline to Week 12

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors · Source last updated 2024-11-27

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

Measure
MEAN
Unit
Units on a scale
Interval / dispersion
Standard Deviation
Time frame
12 weeks (±1 week)

What was measured

The Quality of Life - Cancer Survivor Version ranges from 0-10 with higher scores indicating a higher quality of life. T here are only 2 difference scores for each of the 4 subscales. The min, max, and ranges of these Well-Being Subscales: Physical -1.00, -0.62, and 0.38. Psychological -0.72, 0.94, and 1.67. Social 0.75, 1.25, and 0.50. Spiritual -1.57, 3.29, and 4.86. For Psychological the min, max, and range are 2.61, 6.83, and 4.22. For Social the min, max, and range are 2.63, 7.38, and 4.75. For Spiritual the min, max, and range are 4.43, 8.43, and 4.00. A negative difference score indicates a worsening of quality of life while a positive score indicates that qualify of life got better. Subscales were not combined here to produce a total score. For the baseline and week 12 scores on the QOL-CSV, higher scores mean higher quality of life.

Analysis population: Out of 8 participants assigned to a treatment arm, only 2 took the QOL-CSV at both the baseline and 12-week visits.

Groups in this outcome

Intrarosa & Standard of Care Aromatase Inhibitor

Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).

Replens & Standard of Care Aromatase Inhibitor

Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Intrarosa & Standard of Care Aromatase Inhibitor2
Replens & Standard of Care Aromatase Inhibitor0

Reported measurements

QOL-CSV Physical Well-Being Subscale
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intrarosa & Standard of Care Aromatase Inhibitor-0.810.27Not reportedNot reportedNot reported
QOL-CSV Psychological Well-Being Subscale
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intrarosa & Standard of Care Aromatase Inhibitor0.111.18Not reportedNot reportedNot reported
QOL-CSV Social Well-Being Subscale
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intrarosa & Standard of Care Aromatase Inhibitor1.000.35Not reportedNot reportedNot reported
QOL-CSV Spiritual Well-Being Subscale
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intrarosa & Standard of Care Aromatase Inhibitor0.863.43Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.27
        value
        -0.81
    title
    QOL-CSV Physical Well-Being Subscale
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.18
        value
        0.11
    title
    QOL-CSV Psychological Well-Being Subscale
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.35
        value
        1.00
    title
    QOL-CSV Social Well-Being Subscale
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.43
        value
        0.86
    title
    QOL-CSV Spiritual Well-Being Subscale
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      0
    units
    Participants
description
The Quality of Life - Cancer Survivor Version ranges from 0-10 with higher scores indicating a higher quality of life. T here are only 2 difference scores for each of the 4 subscales. The min, max, and ranges of these Well-Being Subscales: Physical -1.00, -0.62, and 0.38. Psychological -0.72, 0.94, and 1.67. Social 0.75, 1.25, and 0.50. Spiritual -1.57, 3.29, and 4.86. For Psychological the min, max, and range are 2.61, 6.83, and 4.22. For Social the min, max, and range are 2.63, 7.38, and 4.75. For Spiritual the min, max, and range are 4.43, 8.43, and 4.00. A negative difference score indicates a worsening of quality of life while a positive score indicates that qualify of life got better. Subscales were not combined here to produce a total score. For the baseline and week 12 scores on the QOL-CSV, higher scores mean higher quality of life.
dispersion Type
Standard Deviation
groups
  1. description
    Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).
    id
    OG000
    title
    Intrarosa & Standard of Care Aromatase Inhibitor
  2. description
    Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).
    id
    OG001
    title
    Replens & Standard of Care Aromatase Inhibitor
param Type
MEAN
population Description
Out of 8 participants assigned to a treatment arm, only 2 took the QOL-CSV at both the baseline and 12-week visits.
reporting Status
POSTED
time Frame
12 weeks (±1 week)
title
Difference in Quality of Life on the Quality of Life - Cancer Survivor Version (QOL-CSV) From Baseline to Week 12
type
SECONDARY
unit Of Measure
Units on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice