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NCT04437472 Clinical Trial

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

Cancer Clinical Trial

Official title:
Remote Collection of Patient Reported Toxicity Using SMS Text Messaging

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04437472
Other study ID # 202005063
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 22, 2020
Est. completion date July 9, 2021

Study information
Verified date August 2021
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 9, 2021
Est. primary completion date July 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. Exclusion Criteria: -Unable to reliably access and use a device compatible with CareSignal software.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• CareSignal
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.

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of invited symptom reports completed during the study period From treatment through 30 days follow-up (estimated to be 3 months)
Primary Percentage of questions completed within each invited symptom report From treatment through 30 days follow-up (estimated to be 3 months)
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