Programs To Support You During 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.

Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

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.

Time frame: At 0-2 weeks after start of intervention

Population: 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 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.

Time frame: At 8-10 weeks after start of intervention

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

Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

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

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.

Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

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.

Time frame: At 0-2 weeks and 8-10 weeks after start of intervention

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

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.

Time frame: At 0-2 weeks and 8-10 weeks after start of intervention

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

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.

Time frame: At 2 weeks after start of intervention

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

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.

Time frame: At 10 weeks after start of intervention

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

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.

Time frame: Up 10 weeks after start of intervention

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.

Time frame: At 14 weeks after start of intervention

Population: 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.

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

Time frame: At baseline, 2 weeks, 8 weeks, 10 weeks and 14 weeks after start of intervention

Population: 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.

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.

Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

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.

Time frame: At 0-2 weeks and 8-10 weeks after start of intervention

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

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.

Time frame: At 0-2 weeks and 8-10 weeks after start of intervention

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

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.

Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

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

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.

Time frame: At 2 weeks after start of intervention

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.

Time frame: At 10 weeks after start of intervention

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

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.

Time frame: At 10 weeks after start of intervention

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

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.

Time frame: At 2 weeks after start of intervention