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

Remote Collection of Patient Reported Toxicity Using SMS Text Messaging

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: CareSignal

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing radiation therapy at Siteman Cancer Center at Washington University School of Medicine.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Matthew B Spraker, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Actual): July 9, 2021
• Study Completion (Actual): July 9, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 202005063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No