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2016-08
2020-01
2020-01
44
NCT02489422
Wake Forest University Health Sciences
Wake Forest University Health Sciences
INTERVENTIONAL
Programs To Support You During Chemotherapy
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-06-29 | 2021-02-08 | 2022-09-15 |
2015-06-30 | 2021-05-03 | 2022-10-14 |
2015-07-03 | 2021-05-27 | 2022-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 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. | OTHER: Laboratory Biomarker Analysis
OTHER: Questionnaire Administration
OTHER: Daily Survey Administration
BEHAVIORAL: Yoga Skills Training
OTHER: Actigraphy Assessment
|
| ACTIVE_COMPARATOR: Group II (Attention Control) Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. | OTHER: Laboratory Biomarker Analysis
OTHER: Questionnaire Administration
OTHER: Daily Survey Administration
BEHAVIORAL: Attention Control
OTHER: Actigraphy Assessment
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
21 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
