CancerNCT04437472
Remote Collection of Patient Reported Toxicity Using SMS Text Messaging (CareSignal)
An observational study of Cancer, run by Washington University School of Medicine at 1 site in United States.
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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CareSignal
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 9 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing radiation therapy at Siteman Cancer Center at Washington University School of Medicine.
Who may be able to join
- 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.
Who cannot join
- -Unable to reliably access and use a device compatible with CareSignal software.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- CareSignal
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareSignalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CareSignal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of invited symptom reports completed during the study period
Measured: From treatment through 30 days follow-up (estimated to be 3 months)
Percentage of questions completed within each invited symptom report
Measured: From treatment through 30 days follow-up (estimated to be 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start22 Sep 2020
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew B Spraker, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437472
- Sponsor's protocol ID
- 202005063
- Status last verified
- Aug 2021
- First submitted
- 15 Jun 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Collection of Patient Reported Toxicity Using SMS Text Messaging
- ClinicalTrials.gov ID
- NCT04437472
- Acronym / sponsor ID
- 202005063
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CareSignal | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing radiation therapy at Siteman Cancer Center at Washington University School of Medicine.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -Unable to reliably access and use a device compatible with CareSignal software.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CareSignalThe 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. | Other | CareSignal |
Primary outcome
Percentage of invited symptom reports completed during the study period
Time frame: From treatment through 30 days follow-up (estimated to be 3 months)
Percentage of questions completed within each invited symptom report
Time frame: From treatment through 30 days follow-up (estimated to be 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew B Spraker, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of invited symptom reports completed during the study period (time frame: From treatment through 30 days follow-up (estimated to be 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.