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NCT01401907 · OUTCOME

Family Caregiver Quality of Life as Measured by the SF-36

Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies · Source last updated 2023-10-19

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
95% Confidence Interval
Time frame
Week-12 and Week-24

What was measured

The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.

Analysis population: Adjusted Means controlling for baseline scores. The different rows reflect Week-12 and Week-24 outcomes on SF-36 PCS and MCS domains. The number of participants included in week-12 and week-24 analyses reflect the participants who completed the SF-36 at these time points, which explains the discrepancy with the flow chart.

Groups in this outcome

Early Palliative Care

Not reported

Standard Oncology Care

Not reported

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

Analysis denominator · Participants

GroupSource count
Early Palliative Care110
Standard Oncology Care119

Reported measurements

SF36 PCS Week-12

Analysis denominator · Participants

GroupSource count
Early Palliative Care110
Standard Oncology Care119
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Early Palliative Care52.94Not reported51.3054.59Not reported
Standard Oncology Care51.40Not reported49.8352.98Not reported
SF36 MCS Week-12

Analysis denominator · Participants

GroupSource count
Early Palliative Care110
Standard Oncology Care119
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Early Palliative Care47.00Not reported45.2648.74Not reported
Standard Oncology Care45.92Not reported44.2547.59Not reported
SF36 PCS Week-24

Analysis denominator · Participants

GroupSource count
Early Palliative Care89
Standard Oncology Care94
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Early Palliative Care52.71Not reported51.0254.40Not reported
Standard Oncology Care53.22Not reported51.5854.86Not reported
SF36 MCS Week-24

Analysis denominator · Participants

GroupSource count
Early Palliative Care89
Standard Oncology Care94
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Early Palliative Care46.21Not reported44.0948.33Not reported
Standard Oncology Care45.59Not reported44.0948.33Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.30
        upper Limit
        54.59
        value
        52.94
      2. group Id
        OG001
        lower Limit
        49.83
        upper Limit
        52.98
        value
        51.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        110
      2. group Id
        OG001
        value
        119
      units
      Participants
    title
    SF36 PCS Week-12
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        45.26
        upper Limit
        48.74
        value
        47.00
      2. group Id
        OG001
        lower Limit
        44.25
        upper Limit
        47.59
        value
        45.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        110
      2. group Id
        OG001
        value
        119
      units
      Participants
    title
    SF36 MCS Week-12
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.02
        upper Limit
        54.40
        value
        52.71
      2. group Id
        OG001
        lower Limit
        51.58
        upper Limit
        54.86
        value
        53.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        94
      units
      Participants
    title
    SF36 PCS Week-24
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44.09
        upper Limit
        48.33
        value
        46.21
      2. group Id
        OG001
        lower Limit
        44.09
        upper Limit
        48.33
        value
        45.59
    denoms
    1. counts
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        94
      units
      Participants
    title
    SF36 MCS Week-24
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    2. group Id
      OG001
      value
      119
    units
    Participants
description
The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.
dispersion Type
95% Confidence Interval
groups
  1. id
    OG000
    title
    Early Palliative Care
  2. id
    OG001
    title
    Standard Oncology Care
param Type
MEAN
population Description
Adjusted Means controlling for baseline scores. The different rows reflect Week-12 and Week-24 outcomes on SF-36 PCS and MCS domains. The number of participants included in week-12 and week-24 analyses reflect the participants who completed the SF-36 at these time points, which explains the discrepancy with the flow chart.
reporting Status
POSTED
time Frame
Week-12 and Week-24
title
Family Caregiver Quality of Life as Measured by the SF-36
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice