NCT02489422 · OUTCOME

Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)

Programs To Support You During Chemotherapy · Source last updated 2022-10-14

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

Measure: MEAN
Unit: score on a scale
Interval / dispersion: Standard Error
Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

What was measured

Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.

Groups in this outcome

Group I (Yoga Skills Training)

Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies

Group II (Attention Control)

Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies

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
Group I (Yoga Skills Training)	23
Group II (Attention Control)	21

Reported measurements

Baseline

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group I (Yoga Skills Training)	53.1	1.8	Not reported	Not reported	Not reported
Group II (Attention Control)	56.8	1.9	Not reported	Not reported	Not reported

8 weeks

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group I (Yoga Skills Training)	53.0	2.1	Not reported	Not reported	Not reported
Group II (Attention Control)	57.2	2.2	Not reported	Not reported	Not reported

10 weeks

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group I (Yoga Skills Training)	51.1	2.2	Not reported	Not reported	Not reported
Group II (Attention Control)	57.2	2.4	Not reported	Not reported	Not reported

14 weeks

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group I (Yoga Skills Training)	55.4	2.2	Not reported	Not reported	Not reported
Group II (Attention Control)	60.6	2.3	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1.8
value
53.1
group Id
OG001
spread
1.9
value
56.8
title
Baseline
categories
measurements
group Id
OG000
spread
2.1
value
53.0
group Id
OG001
spread
2.2
value
57.2
title
8 weeks
categories
measurements
group Id
OG000
spread
2.2
value
51.1
group Id
OG001
spread
2.4
value
57.2
title
10 weeks
categories
measurements
group Id
OG000
spread
2.2
value
55.4
group Id
OG001
spread
2.3
value
60.6
title
14 weeks

denoms

counts
group Id
OG000
value
23
group Id
OG001
value
21
units
Participants

description

dispersion Type

Standard Error

groups

description
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies
id
OG000
title
Group I (Yoga Skills Training)
description
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
id
OG001
title
Group II (Attention Control)

param Type

MEAN

reporting Status

POSTED

time Frame

At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

title

Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)

type

PRIMARY

unit Of Measure

score on a scale

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Preserved source evidence · Not medical advice