Clinical trial NCT02574897: The Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Chemotherapy
Official title: Evaluating the Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Intensive Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stem Cell Transplantation, Hematopoietic
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Average peak symptom burden in the intervention group versus the control group
timeFrame: Measured by comparing the average PRO-CTCAE scores from Day+7, Day+10, and Day+14 in the intervention compared to the control group
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Ashley L Bryant, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bryant AL, Coffman E, Phillips B, Tan X, Bullard E, Hirschey R, Bradley J, Bennett AV, Stover AM, Song L, Shea TC, Wood WA. Pilot randomized trial of an electronic symptom monitoring and reporting intervention for hospitalized adults undergoing hematopoietic stem cell transplantation. Support Care Cancer. 2020 Mar;28(3):1223-1231. doi: 10.1007/s00520-019-04932-9. Epub 2019 Jun 20.