Advanced Renal Cell CarcinomaNCT03229083
Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma
A study testing Carevive software in people with Advanced Renal Cell Carcinoma, run by University of Rochester at 1 site in United States.
Trial summary
To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- What is being tested?
- Carevive software
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2019to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease
- Greater than 18 years of age
- A participating Wilmot Cancer Center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced RCC; this can be for first-line or any subsequent line therapy
- Able to provide written informed consent
- Proficient in the English language and self-reports as literate
- Must have an active email address or access to a smart device on which text messages can be received
Who cannot join
- Women cannot be breast-feeding
- Does not have regular access to the internet
- Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for routine visits with their primary oncologist
- Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester - Wilmot Cancer Institute
Rochester, New York, 14642
About this study
Official title: Monitoring of Treatment Related Toxicities From Oral Targeted Agents and Immunotherapy Among Patients With Advanced Renal Cell Carcinoma (RCC) Using Carevive Software, a Single-Arm Phase II Feasibility Study
To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.
- Conditions
- Advanced Renal Cell Carcinoma
- Being tested
- Carevive software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carevive softwareOther
In this study, Carevive will deliver a link to subjects so that an online survey can be completed. The survey will occur weekly for the first 12 weeks of the study and will be spaced out to every other week thereafter. The questions will mostly focus on side effects from their cancer therapy, as well as a few questions about drug compliance and healthcare utilization. After completion of the survey, the subject will be given a care plan with at home self-management options for drug-related toxicities.
| Study group | Role | What they receive |
|---|---|---|
| Use of Carevive software | Experimental | Reporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC). Receives: Other: Carevive software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Submitted at Least One Carevive Survey
Number of participants who completed at least one Carevive survey at any time during the 48 week study period.
Measured: From enrollment through 48 weeks
Percentage of Carevive Surveys Completed Per Participant
Percentage of Carevive surveys completed by each participant, calculated as the number of completed surveys divided by the number of surveys prompted by the Carevive software during the 48 week study period.
Measured: From enrollment through 48 weeks
Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
Number of participants who accessed at least one auto-generated Carevive care plan at any time during the 48 week study period.
Measured: From enrollment through 48 weeks
Percentage of Auto Generated Carevive Care Plans Utilized Per Participant
Percentage of auto generated Carevive care plans utilized by each participant, calculated as the number of care plans accessed divided by the total number of care plans generated for that participant during the 48 week study period.
Measured: From enrollment through 48 weeks
System Usability Scale (SUS) Score for Carevive Software
Participants completed the System Usability Scale (SUS), which is a validated 10-item questionnaire that produces a total usability score ranging from 0 to 100. Scores are categorized into three main categories: excellent (>80.3 points); good (68.0 to 80.3 points) and below average (<68 points). We calculated the SUS point for each participant who completed the survey.
Measured: From enrollment through 48 weeks
Secondary outcomes (23)
Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
The FKSI-DRS is a validated patient-reported outcome measure assessing kidney cancer-related symptoms, with total scores ranging from 0 to 36, where higher scores indicate better quality of life.
Measured: From enrollment through 48 weeks
Distress Level Assessed by NCCN Distress Thermometer
The NCCN Distress Thermometer is a validated patient reported outcome measure assessing psychological distress on a scale from 0 to 10, with higher scores indicating greater distress. Scores were categorized to reflect low distress (0-3) and moderate to severe distress (4-10).
Measured: From enrollment through 48 weeks
Health Care Utilization Assessment
Health care utilization was assessed based on participant self-report and defined as having at least one hospital visit, emergency room visit, or unplanned clinic visit during the 48-week study period.
Measured: From enrollment through 48 weeks
Participants Reporting Diarrhea
Number of participants who self reported Diarrhea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
Measured: From enrollment through 48 weeks
Participants Reporting Nausea
Number of participants who self reported nausea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy. Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
Measured: From enrollment through 48 weeks
Participants Reporting Vomiting
Number of participants who self reported vomiting (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy. Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
Measured: From enrollment through 48 weeks
Participants Reporting Fatigue
Number of participants who self reported fatigue (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy. Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
Measured: From enrollment through 48 weeks
Participants Reporting Rash
Number of participants who self reported rash (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
Measured: From enrollment through 48 weeks
Participants Reporting Abdominal Pain
Number of participants who self reported abdominal pain (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
Measured: From enrollment through 48 weeks
Participants Reporting Mouth Sores
Number of participants who self reported mouth sores (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
Measured: From enrollment through 48 weeks
Participants Reporting Cough
Number of participants who self reported cough (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
Measured: From enrollment through 48 weeks
Participants Reporting Shortness of Breath
Number of participants who self reported Shortness of Breath (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
Measured: From enrollment through 48 weeks
Participants Reporting Anorexia
Number of participants who self reported Anorexia (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
Measured: From enrollment through 48 weeks
Clinician Reported Diarrhea
Number of participants with clinician reported diarrhea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
Measured: From enrollment through 48 weeks
Clinician Reported Nausea
Number of participants with clinician reported nausea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
Measured: From enrollment through 48 weeks
Clinician Reported Vomiting
Number of participants with clinician reported vomiting assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
Measured: From enrollment through 48 weeks
Clinician Reported Fatigue
Number of participants with clinician reported fatigue assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
Measured: From enrollment through 48 weeks
Clinician Reported Rash
Number of participants with clinician reported Rash assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
Measured: From enrollment through 48 weeks
Clinician Reported Abdominal Pain
Number of participants with clinician reported Abdominal Pain assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
Measured: From enrollment through 48 weeks
Clinician Reported Mouth Sores
Number of participants with clinician reported Mouth Sores assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
Measured: From enrollment through 48 weeks
Clinician Reported Cough
Number of participants with clinician reported Cough assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
Measured: From enrollment through 48 weeks
Clinician Reported Shortness of Breath
Number of participants with clinician reported Shortness of Breath assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
Measured: From enrollment through 48 weeks
Clinician Reported Anorexia
Number of participants with clinician reported Anorexia assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
Measured: From enrollment through 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start24 Jul 2019
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Chunkit Fung, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229083
- Sponsor's protocol ID
- UGUK 17036
- Other IDs
- UG1CA189961
- Status last verified
- Feb 2025
- First submitted
- 18 Jul 2017
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Treatment Related Toxicities From Oral Targeted Agents and Immunotherapy Among Patients With Advanced Renal Cell Carcinoma (RCC) Using Carevive Software, a Single-Arm Phase II Feasibility Study
- ClinicalTrials.gov ID
- NCT03229083
- Acronym / sponsor ID
- UGUK 17036
- Conditions
- Advanced Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Posted 7 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Carevive software | Experimental | Other: Carevive softwareReporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease
- Greater than 18 years of age
- A participating Wilmot Cancer Center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced RCC; this can be for first-line or any subsequent line therapy
- Able to provide written informed consent
- Proficient in the English language and self-reports as literate
Key exclusion criteria (4 listed)
- Women cannot be breast-feeding
- Does not have regular access to the internet
- Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for routine visits with their primary oncologist
- Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change
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 |
|---|---|---|
| Carevive softwareIn this study, Carevive will deliver a link to subjects so that an online survey can be completed. The survey will occur weekly for the first 12 weeks of the study and will be spaced out to every other week thereafter. The questions will mostly focus on side effects from their cancer therapy, as well as a few questions about drug compliance and healthcare utilization. After completion of the survey, the subject will be given a care plan with at home self-management options for drug-related toxicities. | Other | Use of Carevive software |
Primary outcome
Number of Participants Who Submitted at Least One Carevive Survey
Time frame: From enrollment through 48 weeks
Number of participants who completed at least one Carevive survey at any time during the 48 week study period.
Percentage of Carevive Surveys Completed Per Participant
Time frame: From enrollment through 48 weeks
Percentage of Carevive surveys completed by each participant, calculated as the number of completed surveys divided by the number of surveys prompted by the Carevive software during the 48 week study period.
Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
Time frame: From enrollment through 48 weeks
Number of participants who accessed at least one auto-generated Carevive care plan at any time during the 48 week study period.
Percentage of Auto Generated Carevive Care Plans Utilized Per Participant
Time frame: From enrollment through 48 weeks
Percentage of auto generated Carevive care plans utilized by each participant, calculated as the number of care plans accessed divided by the total number of care plans generated for that participant during the 48 week study period.
System Usability Scale (SUS) Score for Carevive Software
Time frame: From enrollment through 48 weeks
Participants completed the System Usability Scale (SUS), which is a validated 10-item questionnaire that produces a total usability score ranging from 0 to 100. Scores are categorized into three main categories: excellent (>80.3 points); good (68.0 to 80.3 points) and below average (<68 points). We calculated the SUS point for each participant who completed the survey.
23 secondary outcomes
Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
Time frame: From enrollment through 48 weeks
Distress Level Assessed by NCCN Distress Thermometer
Time frame: From enrollment through 48 weeks
Health Care Utilization Assessment
Time frame: From enrollment through 48 weeks
Participants Reporting Diarrhea
Time frame: From enrollment through 48 weeks
Participants Reporting Nausea
Time frame: From enrollment through 48 weeks
Participants Reporting Vomiting
Time frame: From enrollment through 48 weeks
Participants Reporting Fatigue
Time frame: From enrollment through 48 weeks
Participants Reporting Rash
Time frame: From enrollment through 48 weeks
Participants Reporting Abdominal Pain
Time frame: From enrollment through 48 weeks
Participants Reporting Mouth Sores
Time frame: From enrollment through 48 weeks
Participants Reporting Cough
Time frame: From enrollment through 48 weeks
Participants Reporting Shortness of Breath
Time frame: From enrollment through 48 weeks
Participants Reporting Anorexia
Time frame: From enrollment through 48 weeks
Clinician Reported Diarrhea
Time frame: From enrollment through 48 weeks
Clinician Reported Nausea
Time frame: From enrollment through 48 weeks
Clinician Reported Vomiting
Time frame: From enrollment through 48 weeks
Clinician Reported Fatigue
Time frame: From enrollment through 48 weeks
Clinician Reported Rash
Time frame: From enrollment through 48 weeks
Clinician Reported Abdominal Pain
Time frame: From enrollment through 48 weeks
Clinician Reported Mouth Sores
Time frame: From enrollment through 48 weeks
Clinician Reported Cough
Time frame: From enrollment through 48 weeks
Clinician Reported Shortness of Breath
Time frame: From enrollment through 48 weeks
Clinician Reported Anorexia
Time frame: From enrollment through 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carevive software in people with Advanced Renal Cell Carcinoma, run by University of Rochester 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 6 inclusion and 4 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 7 May 2026. 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?
Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Submitted at Least One Carevive Survey (time frame: From enrollment through 48 weeks). The study lists 5 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 7 May 2026.