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NCT Number: NCT02574897

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic symptom survey

Other

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

Other names: Online Daily Symptom Survey

Blinded Electronic Symptom Survey

Other

Standard of care daily clinician interviews with blinded symptom surveys

Primary outcomes

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

    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

    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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

Evaluating the Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Intensive Chemotherapy

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2015
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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