Advanced Renal Cell Carcinoma
Conditions
Brief 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). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.
Interventions
OTHERCarevive software
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.
Sponsors
University of Rochester
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Submitted at Least One Carevive Survey | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score | From enrollment through 48 weeks | 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. |
| Distress Level Assessed by NCCN Distress Thermometer | From enrollment through 48 weeks | 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). |
| Health Care Utilization Assessment | From enrollment through 48 weeks | 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. |
| Participants Reporting Diarrhea | From enrollment through 48 weeks | 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. |
| Participants Reporting Nausea | From enrollment through 48 weeks | 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. |
| Participants Reporting Vomiting | From enrollment through 48 weeks | 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. |
| Participants Reporting Fatigue | From enrollment through 48 weeks | 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. |
| Participants Reporting Rash | From enrollment through 48 weeks | 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. |
| Participants Reporting Abdominal Pain | From enrollment through 48 weeks | 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. |
| Participants Reporting Mouth Sores | From enrollment through 48 weeks | 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. |
| Participants Reporting Cough | From enrollment through 48 weeks | 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. |
| Participants Reporting Shortness of Breath | From enrollment through 48 weeks | 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. |
| Participants Reporting Anorexia | From enrollment through 48 weeks | 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. |
| Clinician Reported Diarrhea | From enrollment through 48 weeks | 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. |
| Clinician Reported Nausea | From enrollment through 48 weeks | 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. |
| Clinician Reported Vomiting | From enrollment through 48 weeks | 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. |
| Clinician Reported Fatigue | From enrollment through 48 weeks | 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. |
| Clinician Reported Rash | From enrollment through 48 weeks | 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. |
| Clinician Reported Abdominal Pain | From enrollment through 48 weeks | 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. |
| Clinician Reported Mouth Sores | From enrollment through 48 weeks | 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. |
| Clinician Reported Cough | From enrollment through 48 weeks | 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. |
| Clinician Reported Shortness of Breath | From enrollment through 48 weeks | 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. |
| Clinician Reported Anorexia | From enrollment through 48 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
The study coordinators and investigators reviewed medical records of patients undergoing treatment for advanced renal cell carcinoma to identify patients who meet eligibility criteria for clinical study. Potential eligible participants were then approached by study team at next scheduled clinic follow up visit to discuss their interests in participation in the study.
Pre-assignment details
Twenty one participants provided informed consent, met eligibility criteria, and were assigned to the Carevive Software Program arm.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Currently Smoke Cigarettes No | 16 Participants |
| Currently Smoke Cigarettes Unknown | 5 Participants |
| Currently Smoke Cigarettes Yes | 0 Participants |
| Educational Level Did not graduate high school | 1 Participants |
| Educational Level Four-year college degree | 3 Participants |
| Educational Level High school graduate or GED | 4 Participants |
| Educational Level Post-graduate or professional degree | 2 Participants |
| Educational Level Training after high school without college degree | 5 Participants |
| Educational Level Unknown | 6 Participants |
| Employment Status Disability Leave | 1 Participants |
| Employment Status Employed | 6 Participants |
| Employment Status Other | 2 Participants |
| Employment Status Retired | 8 Participants |
| Employment Status Unknown | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Ever Smoked Cigarettes No | 8 Participants |
| Ever Smoked Cigarettes Unknown | 5 Participants |
| Ever Smoked Cigarettes Yes | 8 Participants |
| Health Rating Excellent | 0 Participants |
| Health Rating Fair | 7 Participants |
| Health Rating Good | 8 Participants |
| Health Rating Poor | 0 Participants |
| Health Rating Unknown | 6 Participants |
| Health Rating Very Good | 0 Participants |
| Marital Status Divorced/Separated/Widowed | 4 Participants |
| Marital Status Married | 12 Participants |
| Marital Status Single | 3 Participants |
| Marital Status Unknown | 2 Participants |
| Number of days within a week that participants consume alcohol 0 day | 7 Participants |
| Number of days within a week that participants consume alcohol One to two days | 3 Participants |
| Number of days within a week that participants consume alcohol Three to seven days | 5 Participants |
| Number of days within a week that participants consume alcohol Unknown | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex/Gender, Customized Female | 5 Participants |
| Sex/Gender, Customized Male | 14 Participants |
| Sex/Gender, Customized Unknown | 2 Participants |
| Total Years Smoked Cigarettes | 12.50 Years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 21 |
| other Total, other adverse events | 13 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
None listed