Programs to Support You During Chemotherapy (Pro-You)

NCT02148406 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-06-23

No results posted yet for this study

Summary

This randomized pilot clinical trial studies Yoga Skills Training or attention control in reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing practices that aim to promote mindfulness and relaxation. Attention control consists of conversations with a caring professional with a recommendation to complete daily home diaries. It is not yet known whether Yoga Skills Training is better than attention control at reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose of this initial feasibility study is to refine study procedures.

Conditions

  • Depressive Symptoms
  • Fatigue
  • Psychosocial Effects of Cancer and Its Treatment
  • Stage IIA Colon Cancer
  • Stage IIA Rectal Cancer
  • Stage IIB Colon Cancer
  • Stage IIB Rectal Cancer
  • Stage IIC Colon Cancer
  • Stage IIC Rectal Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Rectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer

Interventions

BEHAVIORAL

Yoga Skills Training (YST)

Undergo YST

OTHER

questionnaire administration

Ancillary studies

OTHER

fatigue and depressive symptom assessment and management

Ancillary studies

OTHER

psychological stress assessment

Ancillary studies

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

Attention Control

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Stephanie Sohl · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02148406 on ClinicalTrials.gov