Behaviors and Mental Disorders

All Conditions

Neoplasms

Digestive System Diseases

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Depressive Disorder

Esophageal Neoplasms

Fatigue

Pancreatic Neoplasms

Stomach Neoplasms

Depression

Liver Neoplasms

Anus Neoplasms

Colorectal Neoplasms

Biliary Tract Neoplasms

Gallbladder Neoplasms

Intestinal Neoplasms

Appendiceal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Biliary Tract Diseases

Rectal Neoplasms

Anus Diseases

Gallbladder Diseases

Stomach Diseases

Cecal Neoplasms

Cecal Diseases

Esophageal Cancer

Pancreatic Cancer

Stomach Cancer

Biliary Tract Cancer

Gallbladder Cancer

Anal Cancer

Small Intestine Cancer

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.

Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.

Laboratory Biomarker Analysis

Questionnaire Administration

Daily Survey Administration

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.

Yoga Skills Training

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.

Attention Control

Actigraphy Assessment

Stephanie Sohl, MD

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.

Programs To Support You During Chemotherapy

GI 1549: PROGRAMS TO SUPPORT YOU DURING CHEMOTHERAPY (PRO-YOU) A Randomized Controlled Pilot Study of Yoga Compared to an Attention Control in Patients Receiving Chemotherapy

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Percent of all assessments completed and timeliness of completion will be tracked.

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.

National Cancer Institute (NCI)

National Center for Complementary and Integrative Health (NCCIH)

Wake Forest University Health Sciences

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 I (Yoga Skills Training)

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 II (Attention Control)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study coordinator

Baseline

8 weeks

10 weeks

14 weeks

Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)

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.

Circadian Disruption (Daily)

The number of participants is the actual number that completed this portion of the outcome measure during this timeframe that had measurable data.

Baseline leisure score index (LSI)

8 weeks leisure score index (LSI)

10 weeks leisure score index (LSI)

14 weeks leisure score index

Numbers may vary based on number of participants that actually completed intervention materials

Circadian Disruption (Recalled)

Depressive Symptoms Assessed by PROMIS

0-2 weeks

8-10 weeks

Fatigue (Daily)

Depressive Symptoms (Daily)

The number of participants represents the number that completed data to be analyzed for this particular outcome measure.

Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits

Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits

Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits

Baseline, mean

Psychological Stress Assessed by the Perceived Stress Scale (PSS)

0-2 weeks, mean

8-10 weeks, mean

Psychological Stress Assessed by the PSS (Daily)

Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)

Baseline - Stress management

Baseline - Coping with treatment-related side effects

Baseline - Accepting cancer/maintaining positive attitude

Baseline - Affective regulation

8 weeks - Stress management

8 weeks - Coping with treatment-related side effects

8 weeks - Accepting cancer/maintaining positive attitude

8 weeks - Affective regulation

10 weeks - Stress management

10 weeks - Coping with treatment-related side effects

10 weeks - Accepting cancer/maintaining positive attitude

10 weeks - Affective regulation

14 weeks - Stress management

14 weeks - Coping with treatment-related side effects

14 weeks - Accepting cancer/maintaining positive attitude

14 weeks - Affective regulation

Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory

Minutes of Home Practice Completed

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.

Percent of Planned In Person Intervention Sessions Attended

Qualitative feedback will be assessed with a semi-structured interview conducted after completion of all assessments.

Qualitative Interviews - Combined

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Programs To Support You During Chemotherapy	NCT02489422	Depression Fatigue Stage IIA Color... Stage IIB Color... Stage IIC Color... Stage IIIA Colo... Stage IIIB Colo... Stage IIIC Colo... Stage IVA Color... Stage IVB Color... Pancreatic Canc... Esophageal Canc... Appendix Cancer Stomach Cancer Gallbladder Can... Liver Cancer Small Intestine... Large Intestine... Anal Cancer Biliary Tract C... Gastrointestina...	Laboratory Biom... Questionnaire A... Daily Survey Ad... Yoga Skills Tra... Attention Contr... Actigraphy Asse...	21 Years -	Wake Forest University Health Sciences
Programs To Support You During Chemotherapy	NCT02489422	Depression Fatigue Stage IIA Color... Stage IIB Color... Stage IIC Color... Stage IIIA Colo... Stage IIIB Colo... Stage IIIC Colo... Stage IVA Color... Stage IVB Color... Pancreatic Canc... Esophageal Canc... Appendix Cancer Stomach Cancer Gallbladder Can... Liver Cancer Small Intestine... Large Intestine... Anal Cancer Biliary Tract C... Gastrointestina...	Laboratory Biom... Questionnaire A... Daily Survey Ad... Yoga Skills Tra... Attention Contr... Actigraphy Asse...	21 Years -	Wake Forest University Health Sciences
Programs To Support You During Chemotherapy	NCT02489422	Depression Fatigue Stage IIA Color... Stage IIB Color... Stage IIC Color... Stage IIIA Colo... Stage IIIB Colo... Stage IIIC Colo... Stage IVA Color... Stage IVB Color... Pancreatic Canc... Esophageal Canc... Appendix Cancer Stomach Cancer Gallbladder Can... Liver Cancer Small Intestine... Large Intestine... Anal Cancer Biliary Tract C... Gastrointestina...	Laboratory Biom... Questionnaire A... Daily Survey Ad... Yoga Skills Tra... Attention Contr... Actigraphy Asse...	21 Years -	Wake Forest University Health Sciences

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