NCT01401907 · OUTCOME

Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)

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

We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms

Analysis population: Looking at the HADS-total score at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), 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

Group	Source count
Early Palliative Care	110
Standard Oncology Care	119

Reported measurements

HADS-Total Week-12

Analysis denominator · Participants

Group	Source count
Early Palliative Care	110
Standard Oncology Care	119

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Early Palliative Care	9.02	Not reported	8.09	9.96	Not reported
Standard Oncology Care	10.48	Not reported	9.58	11.38	Not reported

HADS-Total Week-24

Analysis denominator · Participants

Group	Source count
Early Palliative Care	89
Standard Oncology Care	94

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Early Palliative Care	9.82	Not reported	8.65	10.99	Not reported
Standard Oncology Care	10.72	Not reported	8.65	10.99	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
8.09
upper Limit
9.96
value
9.02
group Id
OG001
lower Limit
9.58
upper Limit
11.38
value
10.48
denoms
counts
group Id
OG000
value
110
group Id
OG001
value
119
units
Participants
title
HADS-Total Week-12
categories
measurements
group Id
OG000
lower Limit
8.65
upper Limit
10.99
value
9.82
group Id
OG001
lower Limit
8.65
upper Limit
10.99
value
10.72
denoms
counts
group Id
OG000
value
89
group Id
OG001
value
94
units
Participants
title
HADS-Total Week-24

denoms

counts
group Id
OG000
value
110
group Id
OG001
value
119
units
Participants

description

dispersion Type

95% Confidence Interval

groups

id
OG000
title
Early Palliative Care
id
OG001
title
Standard Oncology Care

param Type

MEAN

population Description

Looking at the HADS-total score at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.

reporting Status

POSTED

time Frame

Week 12 and Week 24

title

Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice