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

NCT02574897 | Completed DMC

• 1 other identifier: LCCC 1404
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplantation, Hematopoietic

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Electronic Symptom Survey

EXPERIMENTAL

Patients randomized to the intervention arm will fill out the daily PRO-CTCAE electronic symptom survey. The intervention consists of sending the results of the surveys in the intervention arm to the clinical care team. The four symptom-specific PROMIS subsets (Anxiety, Depression, Fatigue, and Sleep Disturbance) will be filled out weekly while patients are admitted to the hospital. Patients will again complete the 6 minute walk distance testing, HRQoL surveys, and PASS assessment at the time of discharge. Patients in the intervention arm will complete a satisfaction survey at discharge. HRQoL (by mail) and PASS (by telephone) will be assessed for a third time 30 days after discharge.

Other: Electronic symptom survey

Blinded Electronic Symptom Survey

ACTIVE COMPARATOR

Patients in the control arm will only fill out the symptom survey at the time of admission and days 7, 10, and 14. The results of symptom surveys from the patients in the control arm will not be sent to providers, but will be used for data analysis purposes only. The four symptom-specific PROMIS subsets (Anxiety, Depression, Fatigue, and Sleep Disturbance) will be filled out weekly while patients are admitted to the hospital. Patients will again complete the 6 minute walk distance testing, HRQoL surveys, and PASS assessment at the time of discharge. HRQoL (by mail) and PASS (by telephone) will be assessed for a third time 30 days after discharge.

Other: Blinded Electronic Symptom Survey

Interventions

Electronic symptom survey OTHER

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

Also known as: Online Daily Symptom Survey

Electronic Symptom Survey

Blinded Electronic Symptom Survey OTHER

Standard of care daily clinician interviews with blinded symptom surveys

Blinded Electronic Symptom Survey

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concurrent participation in LCCC1234

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• 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.

  PMID: 31222392 DERIVED

Study Officials

• Ashley L Bryant, PHD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: October 14, 2015
• Study Start: July 1, 2014
• Primary Completion: June 30, 2017
• Study Completion: September 1, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)