Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2014-08-31
2015-04-30
Brief Summary
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Detailed Description
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I. To obtain preliminary data on the efficacy of the Yoga Skills Training (YST) for improving the targeted outcomes (primary: fatigue; secondary: depressive symptoms) as compared to the attention control (AC).
II. To explore potential mediators (psychological stress, circadian disruption, inflammation) and moderators (gender, dose of the YST, outcome expectancies) of the effects of the YST on targeted outcomes.
III. To qualitatively assess perceived efficacy of the interventions and acceptance of daily measurement through semi-structured interviews in a subset of participants.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (YST intervention): Patients undergo YST intervention comprising four individualized, 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation during outpatient chemotherapy sessions in weeks 2, 4, 6, and 8. Patients practice awareness - noticing the current state and establishing relaxed breathing for 5 minutes; movement - 7 minutes of gentle movements coordinated with the breath (such as raising and lowering the arms); breathing practice - 3 minutes of inhaling cool air as if through a straw; and meditation - 5 minutes of focus on letting go of physical and mental tension. Patients are given a handout describing the YST and audio recording with devices to play the recording to encourage patients to practice daily. Strategies to increase adherence to home practice will be implemented and patients will be asked to keep home practice logs.
ARM II (attention control): Patients attend four 30-minute in-person sessions with an interventionist in weeks 2, 4, 6, and 8. During these sessions, patients are encouraged to discuss their experiences while receiving chemotherapy and do not receive instruction of movement, meditation or breathing practices. Patients will also be asked to write brief diary entries daily at home.
After completion of study, patients are followed up for 4 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I (YST intervention)
Patients undergo YST intervention comprising four individualized, 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation during outpatient chemotherapy sessions in weeks 2, 4, 6, and 8. Patients practice awareness - noticing the current state and establishing relaxed breathing for 5 minutes; movement - 7 minutes of gentle movements coordinated with the breath (such as raising and lowering the arms); breathing practice - 3 minutes of inhaling cool air as if through a straw; and meditation - 5 minutes of focus on letting go of physical and mental tension. Patients review a handout describing the YST and to encourage patients to practice daily with strategies to increase adherence to home practice. Patients also receive an audio recording of the YST and devices to play the recording and are asked to keep a home practice log.
Yoga Skills Training (YST)
Undergo YST
questionnaire administration
Ancillary studies
fatigue and depressive symptom assessment and management
Ancillary studies
psychological stress assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Arm II (attention control)
Patients attend four 30-minute sessions with an interventionist in weeks 2, 4, 6, and 8. During these sessions, patients are encouraged to discuss their experiences while receiving chemotherapy and do not receive instruction of movement, meditation or breathing practices. Patients will also be asked to write brief diary entries daily at home.
questionnaire administration
Ancillary studies
fatigue and depressive symptom assessment and management
Ancillary studies
psychological stress assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Attention Control
Interventions
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Yoga Skills Training (YST)
Undergo YST
questionnaire administration
Ancillary studies
fatigue and depressive symptom assessment and management
Ancillary studies
psychological stress assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Attention Control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
* Ability to understand and the willingness to sign an informed consent document written in English
Exclusion Criteria
* Has a self-reported history of diagnosed sleep disorders (e.g., obstructive sleep apnea, insomnia), comorbidities associated with poor sleep or fatigue (e.g., chronic fatigue syndrome), or a job with night shifts
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Stephanie Sohl
Principal Investigator
Principal Investigators
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Stephanie Sohl
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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NCI-2014-00905
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICC GI 1416
Identifier Type: OTHER
Identifier Source: secondary_id
VICC GI 1416
Identifier Type: -
Identifier Source: org_study_id
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