Depressive SymptomsPro-YouNCT02148406
Programs to Support You During Chemotherapy (Pro-You)
A study testing Yoga Skills Training (YST), questionnaire administration and fatigue and depressive symptom assessment and management in people with Depressive Symptoms and Fatigue, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies Yoga Skills Training or attention control in reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms, Fatigue, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- Yoga Skills Training (YST), questionnaire administration and fatigue and depressive symptom assessment and management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to receive first-line intravenous chemotherapy treatment for colorectal cancer (stages II-IV)
- 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
Who cannot join
- Regularly engaged (>= 3 days/week) in moderate physical activity of any kind (e.g., yoga) over the past 4 weeks
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Programs to Support You During Chemotherapy (Pro-You): Feasibility
This randomized pilot clinical trial studies Yoga Skills Training or attention control in reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing practices that aim to promote mindfulness and relaxation. Attention control consists of conversations with a caring professional with a recommendation to complete daily home diaries. It is not yet known whether Yoga Skills Training is better than attention control at reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose of this initial feasibility study is to refine study procedures.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Depressive Symptoms, Fatigue, Psychosocial Effects of Cancer and Its Treatment, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer
- Being tested
- Yoga Skills Training (YST), questionnaire administration, fatigue and depressive symptom assessment and management, psychological stress assessment, laboratory biomarker analysis
- Keywords
- Yoga, Mind-body therapies, Fatigue, Colorectal cancer, Depressive symptoms
- Medical subject headings
- Depression, Fatigue, Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Skills Training (YST)Behavioural
Also called yoga
Undergo YST
questionnaire administrationOther
Ancillary studies
fatigue and depressive symptom assessment and managementOther
Also called fatigue and depressive assessment/management
Ancillary studies
psychological stress assessmentOther
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
Attention ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Arm I (YST intervention) | Experimental | 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. Receives: Behavioral: Yoga Skills Training (YST); Other: questionnaire administration; Other: fatigue and depressive symptom assessment and management; Other: psychological stress assessment; Other: laboratory biomarker analysis |
| Arm II (attention control) | Active comparator | 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. Receives: Other: questionnaire administration; Other: fatigue and depressive symptom assessment and management; Other: psychological stress assessment; Other: laboratory biomarker analysis; Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fatigue (recalled)
Patient-Reported Outcomes Measurement Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.
Measured: at 10 weeks
Secondary outcomes (4)
Changes in depressive symptoms (recalled and daily)
Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.
Measured: Baseline up to 14 weeks
Changes in daily fatigue
Patient-Reported Outcomes Measurement Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.
Measured: Baseline up to 14 weeks
Changes in psychological stress (daily and recalled) as assessed by Perceived Stress Scale (PSS)
Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.
Measured: Baseline up to 14 weeks
Regulation of psychological stress (daily and recalled) as assessed by Positive and Negative Affect Schedule-Expanded Form and Cancer Behavior Inventory
Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Stephanie Sohl, Vanderbilt-Ingram Cancer Center
- Investigators
- Stephanie Sohl, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148406
- Sponsor's protocol ID
- VICC GI 1416
- Other IDs
- NCI-2014-00905, VICC GI 1416, P30CA068485
- Acronym
- Pro-You
- Status last verified
- Jun 2015
- First submitted
- 22 May 2014
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programs to Support You During Chemotherapy (Pro-You): Feasibility
- ClinicalTrials.gov ID
- NCT02148406
- Acronym / sponsor ID
- Pro-You / VICC GI 1416
- Conditions
- Depressive Symptoms, Fatigue, Psychosocial Effects of Cancer and Its Treatment, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer
- Keywords
- Yoga, Mind-body therapies, Fatigue, Colorectal cancer, Depressive symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot clinical trial studies Yoga Skills Training or attention control in reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing practices that aim to promote mindfulness and relaxation. Attention control consists of conversations with a caring professional with a recommendation to complete daily home diaries. It is not yet known whether Yoga Skills Training is better than attention control at reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose of this initial feasibility study is to refine study procedures.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (YST intervention) | Experimental | Behavioral: Yoga Skills Training (YST), Other: questionnaire administration, Other: fatigue and depressive symptom assessment and management, Other: psychological stress assessment, Other: laboratory biomarker analysisPatients 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. |
| Arm II (attention control) | Active comparator | Other: questionnaire administration, Other: fatigue and depressive symptom assessment and management, Other: psychological stress assessment, Other: laboratory biomarker analysis, Other: Attention ControlPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to receive first-line intravenous chemotherapy treatment for colorectal cancer (stages II-IV)
- 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
Key exclusion criteria (2 listed)
- Regularly engaged (>= 3 days/week) in moderate physical activity of any kind (e.g., yoga) over the past 4 weeks
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Skills Training (YST)Also: yogaUndergo YST | Behavioural | Arm I (YST intervention) |
| questionnaire administrationAncillary studies | Other | Arm I (YST intervention), Arm II (attention control) |
| fatigue and depressive symptom assessment and managementAlso: fatigue and depressive assessment/managementAncillary studies | Other | Arm I (YST intervention), Arm II (attention control) |
| psychological stress assessmentAncillary studies | Other | Arm I (YST intervention), Arm II (attention control) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (YST intervention), Arm II (attention control) |
| Attention Control | Other | Arm II (attention control) |
Primary outcome
Changes in fatigue (recalled)
Time frame: at 10 weeks
Patient-Reported Outcomes Measurement Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.
4 secondary outcomes
Changes in depressive symptoms (recalled and daily)
Time frame: Baseline up to 14 weeks
Changes in daily fatigue
Time frame: Baseline up to 14 weeks
Changes in psychological stress (daily and recalled) as assessed by Perceived Stress Scale (PSS)
Time frame: Baseline up to 14 weeks
Regulation of psychological stress (daily and recalled) as assessed by Positive and Negative Affect Schedule-Expanded Form and Cancer Behavior Inventory
Time frame: Up to 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Sohl principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Skills Training (YST), questionnaire administration and fatigue and depressive symptom assessment and management in people with Depressive Symptoms and Fatigue, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fatigue (recalled) (time frame: at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.