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

NCT ID: NCT04437472

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-22

Study Completion Date

2021-07-09

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

CareSignal

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew B Spraker, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

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

Other Identifiers

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202005063

Identifier Type: -

Identifier Source: org_study_id

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