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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01042 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 01716 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| K01AT008219 | U.S. NIH Grant/Contract | View source | |
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.
PRIMARY OBJECTIVES:
I. To conduct a pilot randomized controlled trial of the yoga skills training (YST) versus a caring attention control (AC) group among adults with colorectal cancer (CRC) receiving chemotherapy to determine preliminary efficacy for the primary outcome of fatigue, secondary outcome of depressive symptoms, and possible mediators (i.e., psychological stress, circadian disruption, inflammation) as assessed by standard measures.
SECONDARY OBJECTIVES:
I. To measure the impact of the YST versus the AC on daily assessments of fatigue, depressive symptoms, and proposed mediators in the same trial and explore relationships among daily and standard assessments.
II. To qualitatively assess perceived efficacy of the YST and AC and acceptability of new methodology through semi-structured interviews in a subset of 20-40 participants.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (YST): 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.
GROUP II (AC): Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, and 8.
After completion of study, patients are followed up at 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Yoga Skills Training) | Experimental | 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. |
|
| Group II (Attention Control) | Active Comparator | Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) | Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue. | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian Disruption (Daily) | Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data. | At 0-2 weeks after start of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Sohl, MD | Vanderbilt University/Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States | ||
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2019 |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Daily Survey Administration | Other | Ancillary studies |
|
| Yoga Skills Training | Behavioral | 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. |
|
|
| Attention Control | Behavioral | 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 | Other | Ancillary studies |
|
|
| Circadian Disruption (Daily) | Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data. | At 8-10 weeks after start of intervention |
| Circadian Disruption (Recalled) | 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. | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
| Depressive Symptoms Assessed by PROMIS | Will be assessed with the standardized 10-item PROMIS-cancer depressive symptoms short-form. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive the symptoms. Scores on the short form range from 10 to 81.3; 10-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression. | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
| Fatigue (Daily) | Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue. | At 0-2 weeks and 8-10 weeks after start of intervention |
| Depressive Symptoms (Daily) | Depressive symptoms will be assessed with 3 items selected from the PROMIS measure of depression validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive symptoms the participants exhibited. scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression. | At 0-2 weeks and 8-10 weeks after start of intervention |
| Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | At 2 weeks after start of intervention |
| Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | At 10 weeks after start of intervention |
| Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | At 2 weeks after start of intervention |
| Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | At 10 weeks after start of intervention |
| Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | At 2 weeks after start of intervention |
| Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | At 10 weeks after start of intervention |
| Psychological Stress Assessed by the Perceived Stress Scale (PSS) | Psychological stress will be assessed by the 10-item PSS. The PSS has 2 factors (stress and counter stress). Scoring scale range from 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often and 4 - very often. Score range is 0-40. A higher score represents more of the concept being measured. | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
| Psychological Stress Assessed by the PSS (Daily) | Psychological stress will be assessed daily with two items from the 4-item PSS that would be on the same factor to optimize internal consistency. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. A mean of the participants scores was taken. | At 0-2 weeks and 8-10 weeks after start of intervention |
| Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily) | Regulation of psychological stress will be assessed daily with the 3-item serenity subscale (calm, relaxed, at ease) from the Positive and Negative Affect Schedule-Expanded Form. Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely. Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect and lower scores representing lower levels of negative affect. | At 0-2 weeks and 8-10 weeks after start of intervention |
| Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory | 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. | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
| Minutes of Home Practice Completed | Participants will keep daily paper logs of their home practice. In addition, one item will ask via the daily automated survey how many minutes participants practiced the intervention that day for two weeks after completion of the intervention. | Up 10 weeks after start of intervention |
| Percent of Planned In Person Intervention Sessions Attended | Percent of all assessments completed and timeliness of completion will be tracked. | At baseline, 2 weeks, 8 weeks, 10 weeks and 14 weeks after start of intervention |
| Number of Participants With Successful Qualitative Data Collection | Qualitative feedback will be assessed with a semi-structured interview conducted after completion of all assessments. Qualitative information gained will enrich quantitative results and inform the protocol of a larger trial. | At 14 weeks after start of intervention |
| Vanderbilt University/Ingram Cancer Center |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| FG001 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) | Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue. | Posted | Mean | Standard Error | score on a scale | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Circadian Disruption (Daily) | Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data. | Participants analyzed represents the number of participants that completed the analysis and had data for this outcome measure out of the total number of participants for the trial. | Posted | Mean | Standard Error | days | At 0-2 weeks after start of intervention |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Circadian Disruption (Daily) | Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data. | The number of participants is the actual number that completed this portion of the outcome measure during this timeframe that had measurable data. | Posted | Mean | Standard Deviation | days | At 8-10 weeks after start of intervention |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Circadian Disruption (Recalled) | 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. | Numbers may vary based on number of participants that actually completed intervention materials | Posted | Mean | Standard Error | score on a scale | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Depressive Symptoms Assessed by PROMIS | Will be assessed with the standardized 10-item PROMIS-cancer depressive symptoms short-form. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive the symptoms. Scores on the short form range from 10 to 81.3; 10-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression. | Posted | Mean | Standard Error | score on a scale | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Fatigue (Daily) | Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue. | Numbers may vary based on number of participants that actually completed intervention materials | Posted | Mean | Standard Error | score on a scale | At 0-2 weeks and 8-10 weeks after start of intervention |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Depressive Symptoms (Daily) | Depressive symptoms will be assessed with 3 items selected from the PROMIS measure of depression validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive symptoms the participants exhibited. scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression. | Numbers may vary based on number of participants that actually completed intervention materials | Posted | Mean | Standard Error | score on a scale | At 0-2 weeks and 8-10 weeks after start of intervention |
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| Secondary | Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | The number of participants represents the number that completed data to be analyzed for this particular outcome measure. | Posted | Mean | 95% Confidence Interval | pg/ml | At 2 weeks after start of intervention |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | The number of participants represents the number that completed data to be analyzed for this particular outcome measure. | Posted | Mean | 95% Confidence Interval | pg/ml | At 10 weeks after start of intervention |
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| Secondary | Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | Posted | Mean | 95% Confidence Interval | pg/ml | At 2 weeks after start of intervention |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | The number of participants represents the number that completed data to be analyzed for this particular outcome measure. | Posted | Mean | 95% Confidence Interval | pg/ml | At 10 weeks after start of intervention |
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| Secondary | Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | Posted | Mean | 95% Confidence Interval | pg/ml | At 2 weeks after start of intervention |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits | 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. | Numbers may vary based on number of participants that actually completed intervention materials | Posted | Mean | 95% Confidence Interval | pg/ml | At 10 weeks after start of intervention |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Psychological Stress Assessed by the Perceived Stress Scale (PSS) | Psychological stress will be assessed by the 10-item PSS. The PSS has 2 factors (stress and counter stress). Scoring scale range from 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often and 4 - very often. Score range is 0-40. A higher score represents more of the concept being measured. | Posted | Mean | Standard Error | score on a scale | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Psychological Stress Assessed by the PSS (Daily) | Psychological stress will be assessed daily with two items from the 4-item PSS that would be on the same factor to optimize internal consistency. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. A mean of the participants scores was taken. | Numbers may vary based on number of participants that actually completed intervention materials | Posted | Mean | Standard Error | score on a scale | At 0-2 weeks and 8-10 weeks after start of intervention |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily) | Regulation of psychological stress will be assessed daily with the 3-item serenity subscale (calm, relaxed, at ease) from the Positive and Negative Affect Schedule-Expanded Form. Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely. Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect and lower scores representing lower levels of negative affect. | Numbers may vary based on number of participants that actually completed intervention materials | Posted | Mean | Standard Error | score on a scale | At 0-2 weeks and 8-10 weeks after start of intervention |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory | 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. | Numbers may vary based on number of participants that actually completed intervention materials | Posted | Mean | Standard Error | score on a scale | At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention |
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| Secondary | Minutes of Home Practice Completed | Participants will keep daily paper logs of their home practice. In addition, one item will ask via the daily automated survey how many minutes participants practiced the intervention that day for two weeks after completion of the intervention. | Posted | Mean | Standard Error | minutes | Up 10 weeks after start of intervention |
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| Secondary | Percent of Planned In Person Intervention Sessions Attended | Percent of all assessments completed and timeliness of completion will be tracked. | Four in-person interventions were performed per participant at weeks 2, 4, 6, and 8. A total of 92 interventions were available for completion for Group I. A total of 84 interventions were available for completion for Group II. | Posted | Number | total interventions actually completed | At baseline, 2 weeks, 8 weeks, 10 weeks and 14 weeks after start of intervention | total of interventions available | total of interventions available |
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| Secondary | Number of Participants With Successful Qualitative Data Collection | Qualitative feedback will be assessed with a semi-structured interview conducted after completion of all assessments. Qualitative information gained will enrich quantitative results and inform the protocol of a larger trial. | As per the protocol, this outcome was intended to be combined after all other data collection is complete to solicit feedback as a group on the acceptability of data collection methods, the participants' experience with both the interventions (e.g., expected efficacy, what was useful), and barriers and facilitators to home practice. It was not intended to be separated but as overall feedback. | Posted | Count of Participants | Participants | At 14 weeks after start of intervention |
|
|
Over 8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 2 | 23 | 4 | 23 | 1 | 23 |
| EG001 | 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 | 2 | 21 | 3 | 21 | 2 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Bowel perforation | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study coordinator | Wake Forest University Health Sciences | 336-716-9055 | megreen@wakehealth.edu |
| Feb 1, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 6, 2019 | Feb 1, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D005221 | Fatigue |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004938 | Esophageal Neoplasms |
| D001063 | Appendiceal Neoplasms |
| D013274 | Stomach Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D008113 | Liver Neoplasms |
| D003110 | Colonic Neoplasms |
| D001005 | Anus Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D002430 | Cecal Neoplasms |
| D002429 | Cecal Diseases |
| D013272 | Stomach Diseases |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
| D008107 | Liver Diseases |
| D012004 | Rectal Neoplasms |
| D001004 | Anus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 10 weeks |
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| 14 weeks |
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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 |
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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
|
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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 |
|
|
|
|
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
|
|
|
|
|
|
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 |
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| 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 |
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