Programs To Support You During Chemotherapy (PRO-YOU)

Wake Forest University (WFU)

Status: Completed

Conditions: Anal Cancer; Appendix Cancer; Esophageal Cancer; Biliary Tract Cancer; Stage IIIB Colorectal Cancer; Stage IVA Colorectal Cancer; Stage IVB Colorectal Cancer; Stage IIC Colorectal Cancer; Fatigue; Stage IIIA Colorectal Cancer; Liver Cancer; Gastrointestinal Stromal Cancer; Small Intestine Cancer; Stage IIIC Colorectal Cancer; Stage IIB Colorectal Cancer; Gallbladder Cancer; Stage IIA Colorectal Cancer; Large Intestine Cancer; Depression; Stomach Cancer; Pancreatic Cancer

Treatments: Other: Laboratory Biomarker Analysis; Other: Daily Survey Administration; Other: Questionnaire Administration; Other: Actigraphy Assessment; Behavioral: Yoga Skills Training; Behavioral: Attention Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02489422

NCI-2015-01042 (Registry Identifier)

P30CA068485 (U.S. NIH Grant/Contract)

CCCWFU 01716 (Other Identifier)

IRB00038321

K01AT008219 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Group I (Yoga Skills Training)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Behavioral: Yoga Skills Training

Other: Actigraphy Assessment

Other: Laboratory Biomarker Analysis

Other: Daily Survey Administration

Group II (Attention Control)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Behavioral: Attention Control

Other: Actigraphy Assessment

Other: Laboratory Biomarker Analysis

Other: Daily Survey Administration