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NCT02489422 · OUTCOME

Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits

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
pg/ml
Interval / dispersion
95% Confidence Interval
Time frame
At 10 weeks after start of intervention

What was measured

Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.

Analysis population: The number of participants represents the number that completed data to be analyzed for this particular outcome measure.

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)16
Group II (Attention Control)13

Reported measurements

Source class 1
Values in pg/ml · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)0.87Not reported0.780.97Not reported
Group II (Attention Control)0.87Not reported0.780.97Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.78
        upper Limit
        0.97
        value
        0.87
      2. group Id
        OG001
        lower Limit
        0.78
        upper Limit
        0.97
        value
        0.87
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
dispersion Type
95% Confidence Interval
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 represents the number that completed data to be analyzed for this particular outcome measure.
reporting Status
POSTED
time Frame
At 10 weeks after start of intervention
title
Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
type
SECONDARY
unit Of Measure
pg/ml

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Preserved source evidence · Not medical advice