Clinical trial NCT02489422: Programs To Support You During Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Fatigue
Stage IIA Colorectal Cancer
Stage IIB Colorectal Cancer
Stage IIC Colorectal Cancer
Stage IIIA Colorectal Cancer
Stage IIIB Colorectal Cancer
Stage IIIC Colorectal Cancer
Stage IVA Colorectal Cancer
Stage IVB Colorectal Cancer
Pancreatic Cancer
Esophageal Cancer
Appendix Cancer
Stomach Cancer
Gallbladder Cancer
Liver Cancer
Small Intestine Cancer
Large Intestine Cancer
Anal Cancer
Biliary Tract Cancer
Gastrointestinal Stromal Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-07-03
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Secondary outcomes:
measure: Circadian Disruption (Daily)
timeFrame: At 0-2 weeks after start of intervention
measure: Circadian Disruption (Daily)
timeFrame: At 8-10 weeks after start of intervention
measure: Circadian Disruption (Recalled)
timeFrame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
measure: Depressive Symptoms Assessed by PROMIS
timeFrame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
measure: Fatigue (Daily)
timeFrame: At 0-2 weeks and 8-10 weeks after start of intervention
measure: Depressive Symptoms (Daily)
timeFrame: At 0-2 weeks and 8-10 weeks after start of intervention
measure: Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
timeFrame: At 2 weeks after start of intervention
measure: Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
timeFrame: At 10 weeks after start of intervention
measure: Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
timeFrame: At 2 weeks after start of intervention
measure: Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
timeFrame: At 10 weeks after start of intervention
measure: Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
timeFrame: At 2 weeks after start of intervention
measure: Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
timeFrame: At 10 weeks after start of intervention
measure: Psychological Stress Assessed by the Perceived Stress Scale (PSS)
timeFrame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
measure: Psychological Stress Assessed by the PSS (Daily)
timeFrame: At 0-2 weeks and 8-10 weeks after start of intervention
measure: Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)
timeFrame: At 0-2 weeks and 8-10 weeks after start of intervention
measure: Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
timeFrame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
measure: Minutes of Home Practice Completed
timeFrame: Up 10 weeks after start of intervention
measure: Percent of Planned In Person Intervention Sessions Attended
timeFrame: At baseline, 2 weeks, 8 weeks, 10 weeks and 14 weeks after start of intervention
measure: Number of Participants With Successful Qualitative Data Collection
timeFrame: At 14 weeks after start of intervention
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University/Ingram Cancer Center
name: Stephanie Sohl, MD
role: PRINCIPAL_INVESTIGATOR
References: