NCT02489422 · OUTCOME
Circadian Disruption (Recalled)
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
Circadian disruption will be assessed with measures of activity and rest. Activity will be measured using the 3-item Godin's leisure score index (LSI), previously used with colorectal cancer patients during chemotherapy. Rest will be assessed with the 8-item PROMIS sleep disturbance short-form. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
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
| Group | Source count |
|---|
| Group I (Yoga Skills Training) | 23 |
|---|
| Group II (Attention Control) | 21 |
|---|
Reported measurements
Baseline leisure score index (LSI)
Analysis denominator · Participants
| Group | Source count |
|---|
| Group I (Yoga Skills Training) | 21 |
|---|
| Group II (Attention Control) | 17 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group I (Yoga Skills Training) | 19.6 | 5.4 | Not reported | Not reported | Not reported |
|---|
| Group II (Attention Control) | 19.9 | 3.6 | Not reported | Not reported | Not reported |
|---|
8 weeks leisure score index (LSI)
Analysis denominator · Participants
| Group | Source count |
|---|
| Group I (Yoga Skills Training) | 15 |
|---|
| Group II (Attention Control) | 16 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group I (Yoga Skills Training) | 24.1 | 7.1 | Not reported | Not reported | Not reported |
|---|
| Group II (Attention Control) | 23.9 | 6.2 | Not reported | Not reported | Not reported |
|---|
10 weeks leisure score index (LSI)
Analysis denominator · Participants
| Group | Source count |
|---|
| Group I (Yoga Skills Training) | 20 |
|---|
| Group II (Attention Control) | 13 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group I (Yoga Skills Training) | 19.8 | 4.4 | Not reported | Not reported | Not reported |
|---|
| Group II (Attention Control) | 29.7 | 12.0 | Not reported | Not reported | Not reported |
|---|
14 weeks leisure score index
Analysis denominator · Participants
| Group | Source count |
|---|
| Group I (Yoga Skills Training) | 16 |
|---|
| Group II (Attention Control) | 13 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group I (Yoga Skills Training) | 24.1 | 5.5 | Not reported | Not reported | Not reported |
|---|
| Group II (Attention Control) | 38.1 | 12.8 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 5.4
- value
- 19.6
- group Id
- OG001
- spread
- 3.6
- value
- 19.9
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- Baseline leisure score index (LSI)
- categories
- measurements
- group Id
- OG000
- spread
- 7.1
- value
- 24.1
- group Id
- OG001
- spread
- 6.2
- value
- 23.9
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- 8 weeks leisure score index (LSI)
- categories
- measurements
- group Id
- OG000
- spread
- 4.4
- value
- 19.8
- group Id
- OG001
- spread
- 12.0
- value
- 29.7
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- 10 weeks leisure score index (LSI)
- categories
- measurements
- group Id
- OG000
- spread
- 5.5
- value
- 24.1
- group Id
- OG001
- spread
- 12.8
- value
- 38.1
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- 14 weeks leisure score index
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 21
- units
- Participants
- description
- Circadian disruption will be assessed with measures of activity and rest. Activity will be measured using the 3-item Godin's leisure score index (LSI), previously used with colorectal cancer patients during chemotherapy. Rest will be assessed with the 8-item PROMIS sleep disturbance short-form. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
- 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
- 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
- Circadian Disruption (Recalled)
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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