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

NCT ID: NCT02574897

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-09-30

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.

Conditions

Stem Cell Transplantation, Hematopoietic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Electronic Symptom Survey

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.

Group Type: EXPERIMENTAL

Electronic symptom survey

Intervention Type: OTHER

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

Blinded Electronic Symptom Survey

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.

Group Type: ACTIVE_COMPARATOR

Blinded Electronic Symptom Survey

Intervention Type: OTHER

Standard of care daily clinician interviews with blinded symptom surveys

Interventions

Electronic symptom survey

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

Intervention Type: OTHER

Blinded Electronic Symptom Survey

Standard of care daily clinician interviews with blinded symptom surveys

Intervention Type: OTHER

Other Intervention Names

Online Daily Symptom Survey

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley L Bryant, PHD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31222392 (View on PubMed)

Other Identifiers

LCCC 1404

Identifier Type: -

Identifier Source: org_study_id