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OpenTrials
Completed

NCT Number: NCT04437472

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CareSignal

Other

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.

Primary outcomes

  1. Percentage of invited symptom reports completed during the study period

    Time frame: From treatment through 30 days follow-up (estimated to be 3 months)

  2. Percentage of questions completed within each invited symptom report

    Time frame: From treatment through 30 days follow-up (estimated to be 3 months)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Remote Collection of Patient Reported Toxicity Using SMS Text Messaging

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2020
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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