- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02574897
The Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Chemotherapy
Evaluating the Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Intensive Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Lineberger Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Standard of care plus daily electronic symptom surveys, the results of which are sent to clinicians electronically.
Other Names:
|
Active Comparator: 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.
|
Standard of care daily clinician interviews with blinded symptom surveys
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured by comparing the average PRO-CTCAE scores from Day+7, Day+10, and Day+14 in the intervention compared to the control group
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ashley L Bryant, PHD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LCCC 1404
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stem Cell Transplantation, Hematopoietic
-
Washington University School of MedicineNational Marrow Donor Program; Predictive BioDiagnostics, LLCCompletedHematopoietic Stem Cell Transplantation | Stem Cell Transplantation, Hematopoietic | Transplantation, Hematopoietic Stem CellUnited States
-
University Hospital, GenevaRecruitingAllogeneic Hematopoietic Stem Cell Transplantation | Hematopoietic Stem Cell Transplantation | Autologous Hematopoietic Stem Cell TransplantationSwitzerland
-
Universitaire Ziekenhuizen KU LeuvenUnknownHematopoietic Stem Cell Transplantation | Hematopoietic Stem Cell Transplantation, Allogeneic
-
Hongnan MoUnknownHematopoietic Stem Cell Transplantation | Thrombocytopoietin | Hematopoietic Stem Cell MobilizationChina
-
National Cancer Institute (NCI)RecruitingHematopoietic Stem Cell TransplantationUnited States
-
Seoul National University HospitalNational Institute of Food and Drug Safety Evaluation (Republic of Korea)RecruitingHematopoietic Stem Cell TransplantationKorea, Republic of
-
University of Michigan Rogel Cancer CenterRecruitingHematopoietic Stem Cell TransplantationUnited States
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de...CompletedHematopoietic Stem Cell TransplantationBrazil
-
Seoul National University HospitalCompletedHematopoietic Stem Cell TransplantationKorea, Republic of
-
University of OsloRecruitingHematopoietic Stem Cell TransplantationNorway
Clinical Trials on Electronic symptom survey
-
Vidya RamanCompleted
-
Trate - Tratamentos EspecializadosUnknown
-
Duke UniversityExelixisTerminatedMetastatic Renal Cell Carcinoma Treated With CabozantinibUnited States
-
Qassim UniversityUnknownCovid19 | Social Media | Perception, Self | Information Seeking BehaviorSaudi Arabia
-
Université de SherbrookeFondation VitaeRecruitingCommunication, MultidisciplinaryCanada
-
Massachusetts Institute of TechnologyMillennium Pharmaceuticals, Inc.CompletedPatient Reported Outcome Measures | ComplianceUnited States
-
KU LeuvenLiantis; Mensura; Belgian Association for Occupational Physicians; IDEWE Occupational...CompletedOccupational Health | Surveys and Questionnaires | ScreeningBelgium
-
M.D. Anderson Cancer CenterActive, not recruitingHead and Neck Cancer | Malignant Neoplasms of Lip Oral Cavity and PharynxUnited States
-
M.D. Anderson Cancer CenterCompletedAdvanced CancersUnited States
-
Thomas Jefferson UniversityPrevent Cancer FoundationCompletedLung CarcinomaUnited States