Programs To Support You During Chemotherapy

NCT02489422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-10-14

Study results available
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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.

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

Interventions

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.

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

Actigraphy Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH
  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Stephanie Sohl, MD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02489422 on ClinicalTrials.gov