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NCT02489422 · OUTCOME

Fatigue (Daily)

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 0-2 weeks and 8-10 weeks after start of intervention

What was measured

Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue.

Analysis population: Numbers may vary based on number of participants that actually completed intervention materials

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

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

Reported measurements

0-2 weeks

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)23
Group II (Attention Control)19
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)49.181.73Not reportedNot reportedNot reported
Group II (Attention Control)53.271.92Not reportedNot reportedNot reported
8-10 weeks

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)16
Group II (Attention Control)14
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)51.002.06Not reportedNot reportedNot reported
Group II (Attention Control)53.292.38Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.73
        value
        49.18
      2. group Id
        OG001
        spread
        1.92
        value
        53.27
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        19
      units
      Participants
    title
    0-2 weeks
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.06
        value
        51.00
      2. group Id
        OG001
        spread
        2.38
        value
        53.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    8-10 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      21
    units
    Participants
description
Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue.
dispersion Type
Standard Error
groups
  1. 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)
  2. 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
population Description
Numbers may vary based on number of participants that actually completed intervention materials
reporting Status
POSTED
time Frame
At 0-2 weeks and 8-10 weeks after start of intervention
title
Fatigue (Daily)
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice