Programs To Support You During Chemotherapy
PRO-YOU
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
5 other identifiers
interventional
44
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Aug 2016
Typical duration for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedResults Posted
Study results publicly available
May 27, 2021
CompletedOctober 14, 2022
September 1, 2022
3.4 years
June 29, 2015
February 8, 2021
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Secondary Outcomes (19)
Circadian Disruption (Daily)
At 0-2 weeks after start of intervention
Circadian Disruption (Daily)
At 8-10 weeks after start of intervention
Circadian Disruption (Recalled)
At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Depressive Symptoms Assessed by PROMIS
At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Fatigue (Daily)
At 0-2 weeks and 8-10 weeks after start of intervention
- +14 more secondary outcomes
Study Arms (2)
Group I (Yoga Skills Training)
EXPERIMENTALPatients 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 (Attention Control)
ACTIVE COMPARATORPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Interventions
Correlative studies
Ancillary studies
Ancillary studies
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.
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.
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study coordinator
- Organization
- Wake Forest University Health Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Sohl, MD
Vanderbilt University/Ingram Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2015
First Posted
July 3, 2015
Study Start
August 1, 2016
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
October 14, 2022
Results First Posted
May 27, 2021
Record last verified: 2022-09