Remote Collection of Patient Reported Toxicity Using SMS Text Messaging (CareSignal)

Completed

• Conditions: Cancer
• Interventions: Other: CareSignal

• Registration Number: NCT04437472
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-18
• Study Start: 2020-09-22
• Primary Completion: 2021-07-09
• Study Completion: 2021-07-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

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Exclusion Criteria

-Unable to reliably access and use a device compatible with CareSignal software.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CareSignal	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.

Primary Outcome Measures

Name	Time	Method
Percentage of questions completed within each invited symptom report	From treatment through 30 days follow-up (estimated to be 3 months)
Percentage of invited symptom reports completed during the study period	From treatment through 30 days follow-up (estimated to be 3 months)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States