CompletedNot Applicable

Programs To Support You During Chemotherapy

United States44 participantsStarted 2016-08

Plain-language 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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)

Timeframe: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention

Trial details

NCT IDNCT02489422

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01

Results submitted2021-02-08

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