An interventional study of Electronic symptom survey and Blinded Electronic Symptom Survey in Stem Cell Transplantation, Hematopoietic, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-03-22.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Health services research
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.
UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
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Exclusion Criteria:
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
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
Standard of care plus daily electronic symptom surveys, the results of which are sent to clinicians electronically.
Also known as: Online Daily Symptom Survey
Standard of care daily clinician interviews with blinded symptom surveys
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
Plan to share: No
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center