The Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Chemotherapy

UNC Lineberger Comprehensive Cancer Center76 enrolled

Overview

The purpose of this randomized trial will evaluate whether providing clinicians with daily reports from a well-validated, standardized, patient-centered electronic symptom survey tool (PRO-CTCAE) improves symptom burden in patients undergoing high-dose chemotherapy. Adult inpatients at UNC undergoing high-dose chemotherapy for preparative chemotherapy prior to stem cell infusion. Participants will be randomized into one of two arms: (1) a control arm with standard of care daily clinician interviews or (2) standard of care plus daily electronic symptom surveys, the results of which will be sent to clinicians electronically.

The primary objective of the study is to compare peak symptom burden between the two study arms (autologous transplant vs. allogeneic transplant). Peak symptom burden will also be compared between the two study arms within both subgroups of patients (myeloablative vs. reduced intensity conditioning). Secondary outcomes that will also be compared between the two arms include: changes in patient-reported quality of life, time to supportive care treatment changes, length of hospital stay, thirty day readmission rate after discharge, days alive and out of the hospital in the 100 days since admission, and overall survival. Additionally, measures of physical activity will be captured through physiological monitoring in order to explore associations with patient-reported symptom measures. Patient and clinician satisfaction will also be evaluated. In this study, the investigators will use an electronic survey to assess 16 patient-reported symptoms to calculate a symptom score that may range from 0-61 each day. This symptom score represents the symptom burden for the patient on that particular day. Symptom burden is anticipated to peak between days 7 and 14, so the investigators will define peak symptom burden as the average of the symptom scores on days 7, 10 and 14. In both arms, symptoms will be assessed on these days in order to compare peak burden.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

Interventions

Electronic symptom surveyOTHER

Standard of care plus daily electronic symptom surveys, the results of which are sent to clinicians electronically.

Blinded Electronic Symptom SurveyOTHER

Standard of care daily clinician interviews with blinded symptom surveys

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Verification of access to a functioning email account * \>= 18 years of age * \<= 75 years of age * Able to read in English * Assessed as competent based on discretion of study personnel * Willing and able to provide signed, informed consent Exclusion Criteria: * Concurrent participation in LCCC1234

Locations (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Average peak symptom burden in the intervention group versus the control group

Peak symptom burden is defined as the average symptom score on chemotherapy days+7, +10, and +14 (relative to transplant day 0) as measured by the PRO-CTCAE. There are 16 items on the PRO-CTCAE questionnaire. Fifteen items are worth 0-4 points each and one item is worth 0-1 point. This translates to a symptom score range of 0-61 per day, which will be averaged over the three days. The outcome is the comparison of average peak symptom burden scores between the two groups.

Time frame: Measured by comparing the average PRO-CTCAE scores from Day+7, Day+10, and Day+14 in the intervention compared to the control group

Data from ClinicalTrials.gov

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