Remote Collection of Patient Reported Toxicity Using SMS Text Messaging (CareSignal)
1 other identifier
observational
30
1 country
1
Brief Summary
CareSignal has developed an application that allows for remote collection of patient-reported data such as symptoms or outcomes on any device compatible with the short message service (SMS), otherwise known as "text messaging". The software can be configured to complete symptom monitoring by surveying patients about toxicity using the PRO-CTCAE tools. PRO-CTCAE is the patient reported outcomes version of the CTCAE that was designed by the National Cancer Institute (NCI) for use in clinical trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
September 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2021
CompletedAugust 25, 2021
August 1, 2021
10 months
June 15, 2020
August 23, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of invited symptom reports completed during the study period
From treatment through 30 days follow-up (estimated to be 3 months)
Percentage of questions completed within each invited symptom report
From treatment through 30 days follow-up (estimated to be 3 months)
Study Arms (1)
CareSignal
-Participants will undergo a single training session on how to use the CareSignal software no more than 4 weeks before starting standard of care therapy. After the training session, patients will be encouraged by the treatment team to complete the baseline symptom report once they receive the questions via SMS prior to starting any therapy and to complete the weekly reports during therapy and in follow up.
Interventions
The CareSignal software will be programmed to automatically ask a subset of the NCI-PRO-CTCAE questions using SMS depending on patient group as designated by the treating physician: (1) thoracic radiation with chemotherapy, (2) thoracic radiation alone, (3) extremity/body wall sarcoma, and (4) other.
Eligibility Criteria
Patients undergoing radiation therapy at Siteman Cancer Center at Washington University School of Medicine.
You may qualify if:
- Currently planning to receive radiotherapy for 2 or more fractions with or without chemotherapy.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- Age 18 years or older.
You may not qualify if:
- Unable to reliably access and use a device compatible with CareSignal software.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew B Spraker, M.D., Ph.D.
Washington University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2020
First Posted
June 18, 2020
Study Start
September 22, 2020
Primary Completion
July 9, 2021
Study Completion
July 9, 2021
Last Updated
August 25, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share