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Clinical Trial VICCGI1416


Programs to Support You During Chemotherapy (Pro-You)

Principal Investigator(s)

Stephanie Sohl


  • Protocol No. VICCGI1416
  • Open Date: 08/19/2014
  • Staging: Pilot
  • Age Group: Adults
  • Scope: Local
  • Objective: To obtain preliminary data on the efficacy of the YST for improving the targeted outcomes (primary: fatigue; secondary: depressive symptoms) as compared to the AC. These pilot data will provide estimates of variability that the YST will show trends for lower fatigue (recalled and daily) and depressive symptoms as compared to AC.
  • Disease Sites: Colon; Rectal
  • Therapies: Supportive Care
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02148406
  • Secondary Protocol No: Not Specified


What are the Programs- - The supportive programs are designed to help you cope with distress you may experience from cancer or cancer treatment. What happens during the Programs- - A study team member will visit you during chemotherapy to guide you through different methods for coping such as counseling, gentle movement, writing, and/or relaxation strategies. - The programs can all be done while sitting in a chair. - You will be asked to do practices we teach you at daily home. Can I choose which Supportive Intervention Program I Receive- - You will be assigned to one of two supportive programs. What will I be asked to do- - Four 30-minute supportive programs during 4 consecutive chemotherapy treatments - Daily home practices - Four study questionnaires that take approximately 30 minutes each to complete - Three blood samples that will be collected during your routine blood draws - Brief daily surveys by phone for 2 weeks before and 2 weeks after the programs - Wear a small device on your wrist for 2 weeks before and 2 weeks after the programs


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Scheduled to receive first-line intravenous chemotherapy treatment for colorectal cancer (stages II-IV)
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
• Ability to understand and the willingness to sign an informed consent document written in English
Exclusion Criteria:
• Regularly engaged (>= 3 days/week) in moderate physical activity of any kind (e.g., yoga) over the past 4 weeks
• Has a self-reported history of diagnosed sleep disorders (e.g., obstructive sleep apnea, insomnia), comorbidities associated with poor sleep or fatigue (e.g., chronic fatigue syndrome), or a job with night shifts