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NCT02489422 · OUTCOME

Circadian Disruption (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
days
Interval / dispersion
Standard Deviation
Time frame
At 8-10 weeks after start of intervention

What was measured

Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.

Analysis population: The number of participants is the actual number that completed this portion of the outcome measure during this timeframe that had measurable data.

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)21
Group II (Attention Control)19

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)11.82.3Not reportedNot reportedNot reported
Group II (Attention Control)11.92.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.3
        value
        11.8
      2. group Id
        OG001
        spread
        2.3
        value
        11.9
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      19
    units
    Participants
description
Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
dispersion Type
Standard Deviation
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
The number of participants is the actual number that completed this portion of the outcome measure during this timeframe that had measurable data.
reporting Status
POSTED
time Frame
At 8-10 weeks after start of intervention
title
Circadian Disruption (Daily)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice