Programs To Support You During Chemotherapy (PRO-YOU)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stomach Cancer; Fatigue; Pancreatic Cancer; Esophageal Cancer; Small Intestine Cancer; Anal Cancer; Liver Cancer; Biliary Tract Cancer; Gallbladder Cancer; Appendix Cancer; Stage IVA Colorectal Cancer; Stage IVB Colorectal Cancer; Stage IIIA Colorectal Cancer; Stage IIIB Colorectal Cancer; Stage IIIC Colorectal Cancer; Large Intestine Cancer; Stage IIA Colorectal Cancer; Stage IIB Colorectal Cancer; Stage IIC Colorectal Cancer; Gastrointestinal Stromal Cancer
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Daily Survey Administration; Behavioral: Yoga Skills Training; Other: Actigraphy Assessment; Behavioral: Attention Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Comprehensive Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University/Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled to receive first-line Fluorouracil (5FU)-based intravenous chemotherapy treatment for a gastrointestinal cancer (stages II-IV)
• Have an Eastern Cooperative Oncology Group performance status of =< 1
• Ability to understand and the willingness to sign and informed consent document in English

Exclusion Criteria:

• Has a self-reported history of diagnosed uncontrolled obstructive sleep apnea (ok if using CPAP), sleep-related seizures, sleep walking more than one time per week, restless leg syndrome, or a job with night shifts

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Other: Daily Survey Administration; Ancillary studies; Behavioral: 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.; Other Names: yoga; YST; Other: Actigraphy Assessment; Ancillary studies; Other Names: Circadian Disruption - daily
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; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Other: Daily Survey Administration; Ancillary studies; Other: Actigraphy Assessment; Ancillary studies; Other Names: Circadian Disruption - daily; Behavioral: 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.; Other Names: empathic attention control; supportive conversation; caring attention control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Stephanie Sohl, MD, Vanderbilt University/Ingram Cancer Center

Publications and helpful links

Helpful Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cecal Diseases; Rectal Neoplasms; Anus Diseases; Cecal Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Anus Neoplasms; Biliary Tract Neoplasms; Gallbladder Neoplasms; Appendiceal Neoplasms
• Other Study ID Numbers: IRB00038321; P30CA068485 (U.S. NIH Grant/Contract); 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)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No