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NCT02489422 · OUTCOME

Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory

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

Regulation of psychological stress will be determined by ratings on four of the seven factors of the Cancer Behavior Inventory, which assess self-efficacy for stress management, coping with treatment-related side-effects, accepting cancer/maintaining positive attitude, and affective regulation. Scale ranged from 1-9 (1 - 3 not at all confident; 4-6 moderately confident and 7-9 totally confident). 4 of the 7 items from the Cancer Behavior Inventory (V2.0) were used with each item's score ranges from 0-50 with higher scores indicating more confidence in the item.

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)20

Reported measurements

Baseline - Stress management

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)23
Group II (Attention Control)20
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)34.81.4Not reportedNot reportedNot reported
Group II (Attention Control)34.21.5Not reportedNot reportedNot reported
Baseline - Coping with treatment-related side effects

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)22
Group II (Attention Control)20
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)33.11.8Not reportedNot reportedNot reported
Group II (Attention Control)30.61.8Not reportedNot reportedNot reported
Baseline - Accepting cancer/maintaining positive attitude

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)23
Group II (Attention Control)20
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)37.81.3Not reportedNot reportedNot reported
Group II (Attention Control)39.30.9Not reportedNot reportedNot reported
Baseline - Affective regulation

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)22
Group II (Attention Control)20
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)28.21.6Not reportedNot reportedNot reported
Group II (Attention Control)29.91.6Not reportedNot reportedNot reported
8 weeks - Stress management

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)18
Group II (Attention Control)16
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)38.11.3Not reportedNot reportedNot reported
Group II (Attention Control)38.61.9Not reportedNot reportedNot reported
8 weeks - Coping with treatment-related side effects

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)18
Group II (Attention Control)16
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)37.11.7Not reportedNot reportedNot reported
Group II (Attention Control)35.42.1Not reportedNot reportedNot reported
8 weeks - Accepting cancer/maintaining positive attitude

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)18
Group II (Attention Control)16
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)40.41.2Not reportedNot reportedNot reported
Group II (Attention Control)38.91.6Not reportedNot reportedNot reported
8 weeks - Affective regulation

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)18
Group II (Attention Control)16
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)29.82.1Not reportedNot reportedNot reported
Group II (Attention Control)31.82.1Not reportedNot reportedNot reported
10 weeks - Stress management

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)20
Group II (Attention Control)13
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)38.21.1Not reportedNot reportedNot reported
Group II (Attention Control)38.51.6Not reportedNot reportedNot reported
10 weeks - Coping with treatment-related side effects

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)20
Group II (Attention Control)13
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)36.81.6Not reportedNot reportedNot reported
Group II (Attention Control)37.52.3Not reportedNot reportedNot reported
10 weeks - Accepting cancer/maintaining positive attitude

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)20
Group II (Attention Control)13
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)40.60.9Not reportedNot reportedNot reported
Group II (Attention Control)40.61.6Not reportedNot reportedNot reported
10 weeks - Affective regulation

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)20
Group II (Attention Control)13
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)30.12.2Not reportedNot reportedNot reported
Group II (Attention Control)33.12.3Not reportedNot reportedNot reported
14 weeks - Stress management

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)17
Group II (Attention Control)15
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)39.21.4Not reportedNot reportedNot reported
Group II (Attention Control)40.11.1Not reportedNot reportedNot reported
14 weeks - Coping with treatment-related side effects

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)17
Group II (Attention Control)15
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)37.01.7Not reportedNot reportedNot reported
Group II (Attention Control)38.41.5Not reportedNot reportedNot reported
14 weeks - Accepting cancer/maintaining positive attitude

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)17
Group II (Attention Control)15
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)40.01.2Not reportedNot reportedNot reported
Group II (Attention Control)41.11.0Not reportedNot reportedNot reported
14 weeks - Affective regulation

Analysis denominator · Participants

GroupSource count
Group I (Yoga Skills Training)17
Group II (Attention Control)15
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group I (Yoga Skills Training)32.32.1Not reportedNot reportedNot reported
Group II (Attention Control)34.01.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.4
        value
        34.8
      2. group Id
        OG001
        spread
        1.5
        value
        34.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    Baseline - Stress management
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.8
        value
        33.1
      2. group Id
        OG001
        spread
        1.8
        value
        30.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    Baseline - Coping with treatment-related side effects
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.3
        value
        37.8
      2. group Id
        OG001
        spread
        0.9
        value
        39.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    Baseline - Accepting cancer/maintaining positive attitude
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6
        value
        28.2
      2. group Id
        OG001
        spread
        1.6
        value
        29.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    Baseline - Affective regulation
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.3
        value
        38.1
      2. group Id
        OG001
        spread
        1.9
        value
        38.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    8 weeks - Stress management
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.7
        value
        37.1
      2. group Id
        OG001
        spread
        2.1
        value
        35.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    8 weeks - Coping with treatment-related side effects
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.2
        value
        40.4
      2. group Id
        OG001
        spread
        1.6
        value
        38.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    8 weeks - Accepting cancer/maintaining positive attitude
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.1
        value
        29.8
      2. group Id
        OG001
        spread
        2.1
        value
        31.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    8 weeks - Affective regulation
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.1
        value
        38.2
      2. group Id
        OG001
        spread
        1.6
        value
        38.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    10 weeks - Stress management
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6
        value
        36.8
      2. group Id
        OG001
        spread
        2.3
        value
        37.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    10 weeks - Coping with treatment-related side effects
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.9
        value
        40.6
      2. group Id
        OG001
        spread
        1.6
        value
        40.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    10 weeks - Accepting cancer/maintaining positive attitude
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.2
        value
        30.1
      2. group Id
        OG001
        spread
        2.3
        value
        33.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    10 weeks - Affective regulation
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Regulation of psychological stress will be determined by ratings on four of the seven factors of the Cancer Behavior Inventory, which assess self-efficacy for stress management, coping with treatment-related side-effects, accepting cancer/maintaining positive attitude, and affective regulation. Scale ranged from 1-9 (1 - 3 not at all confident; 4-6 moderately confident and 7-9 totally confident). 4 of the 7 items from the Cancer Behavior Inventory (V2.0) were used with each item's score ranges from 0-50 with higher scores indicating more confidence in the item.
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 baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
title
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice