Metastatic Renal Cell CarcinomaPRORECECANCT05135832
Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma
A study testing Electronic patient-reported outcomes regarding symptoms and health-related quality of life in people with Metastatic Renal Cell Carcinoma and Kidney Cancer, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
The purpose of PRORECECA is to test whether adding weekly active patient-reported outcomes to the treatment of patients with metastatic renal cell carcinoma can improve patient-reported physical function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasm
- What is being tested?
- Electronic patient-reported outcomes regarding symptoms and health-related quality of life
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Dec 2021to 1 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients with metastatic renal cell carcinoma
- Age ≥ 18 years
- Starting 1st or 2nd line treatment at enrolment
- Performance status (PS) ≤ 2
- Able to read Danish
- No serious cognitive impairment
- Patient has given written informed consent
Who cannot join
- No smart phone
- Patient participating in other interventional studies. This is only relevant for studies that might interfere with the intervention. Cases of doubt will be settled by the protocol committee.
- Persons deprived of liberty or under guardianship or curators
- Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
- Earlier participation in PRORECECA (e.g. when changing from 1st to 2nd line of treatment)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Herlev and Gentofte Hospital
Herlev, 2730
Ida Marie L Rasmussen, MD, +45 38683868, ida.marie.lind.rasmussen@regionh.dk
Anne Kirstine H Møller, MD, PhD, +45 3868 3868, anne.kirstine.hundahl.moeller@regionh.dk
About this study
Official title: Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma; a Randomized Controlled Trial
The purpose of PRORECECA is to test whether adding weekly active patient-reported outcomes to the treatment of patients with metastatic renal cell carcinoma can improve patient-reported physical function.
Read the detailed description
PRORECECA is a two-armed randomized controlled trial for patients with metastatic renal cell carcinoma initiating 1st or 2nd line of standard therapy.
Patients will be randomized to either receiving questions from Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) with a specifically developed alert-algorithm and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) or receiving standard procedure regarding side effect registration and handling.
The hypothesis is that weekly active patient-reported outcomes in the intervention group can improve physical function 30% compared to the group who receive standard care and standard handling of side effects.
A total of 174 patients will be included with 87 patients in each arm.
Primary endpoint is physical function reported by the patient after 3 months of treatment. The patients will assess their physical function by completing the EORTC QLQ-C30.
- Conditions
- Metastatic Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasm, Urologic Cancer, Urologic Neoplasms, Advanced Renal Cell Carcinoma
- Being tested
- Electronic patient-reported outcomes regarding symptoms and health-related quality of life
- Keywords
- Patient-reported outcomes, Electronic reporting of symptoms, Physical function
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic patient-reported outcomes regarding symptoms and health-related quality of lifeDevice
Also called ePRO, Alert-algorithm, active patient-reported outcomes, Real-time guidance of patients when symptom reporting
Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.
The supportive care (including drugs) is similar in the two treatment arms except for the use of electronic patient-reported outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Patient-reported outcomes arm (experimental arm) | Experimental | This arm will be assigned to intervention by weekly electronic reporting of symptoms and side effects in an app. A specifically developed alert-algorithm will in real-time guide the patient to adjust supportive care or contact the hospital.
The reported symptoms are sent to the hospital to a healthcare professional - depending on the severity of the reported symptoms the healthcare professional can schedule a visit at the clinic.
The patient will also receive a health-related quality of life questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) including the Physical Function domain in the app each month.
Patient satisfaction regarding the patient-reported outcomes will be measured with the validated Patient-Reported Experience Measurement questionnaire at termination of participation. Receives: Device: Electronic patient-reported outcomes regarding symptoms and health-related quality of life |
| Standard of care | No intervention | This arm will continue standard procedure regarding side effect registration and handling. The patients will receive a health-related quality of life questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QOL-C30) at baseline, after 1, 3, and 6 months of participation in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Patient-reported physical function in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) - Whether patients using PRO experience a better physical function compared to patients receiving standard care and handling of side effects.
Measured: Within the first 3 months of treatment
Secondary outcomes (6)
Health related quality of life
Registration of differences in quality of life between the two arms in the study.
The quality of life questionnaires EORTC QLQ-C30 (scale range 0-100, a higher score indicating better quality of life) will be used for as quality of life measurement.
Differences between the two arms will be tested using t-test and analysis of covariance (ANCOVA).
Measured: Within the first 6 months of treatment
Admissions (number)
Registration of number of admissions. The registration is made to investigate whether the use of PRO and thereby a closer contact to the clinic between visits can decrease the number of hospital admissions.
Measured: Within the first 6 months of treatment
Admissions (length)
Registration of length of admissions. The registration is made to investigate whether the use of PRO and thereby a closer contact to the clinic between visits can decrease the length of hospital admissions.
Measured: Within the first 6 months of treatment
Symptom management (number)
Registration of differences in number of intervention in the two treatment arms.
Measured: Within the first 6 months of treatment
Symptom management (type)
Registration of differences in types of intervention in the two treatment arms.
Measured: Within the first 6 months of treatment
Number of contacts to the clinic
Registration of number of contacts to the clinic (both phone and attendance). The registration is made to investigate whether the use of PRO de- or increases the number of contacts to the clinic.
Measured: Within the first 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start13 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ida Rasmussen, Herlev and Gentofte Hospital
- Investigators
- Ida Marie L Rasmussen, MD, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135832
- Sponsor's protocol ID
- UR 2134
- Other IDs
- P-2021-693
- Acronym
- PRORECECA
- Status last verified
- Nov 2021
- First submitted
- 27 Oct 2021
- Last updated
- 26 Nov 2021
- Results posted
- 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 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05135832
- Acronym / sponsor ID
- PRORECECA / UR 2134
- Conditions
- Metastatic Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasm, Urologic Cancer, Urologic Neoplasms, Advanced Renal Cell Carcinoma
- Keywords
- Patient-reported outcomes, Electronic reporting of symptoms, Physical function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 13 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 26 Nov 2021 (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.
The purpose of PRORECECA is to test whether adding weekly active patient-reported outcomes to the treatment of patients with metastatic renal cell carcinoma can improve patient-reported physical function.
Detailed description
PRORECECA is a two-armed randomized controlled trial for patients with metastatic renal cell carcinoma initiating 1st or 2nd line of standard therapy.
Patients will be randomized to either receiving questions from Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) with a specifically developed alert-algorithm and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) or receiving standard procedure regarding side effect registration and handling.
The hypothesis is that weekly active patient-reported outcomes in the intervention group can improve physical function 30% compared to the group who receive standard care and standard handling of side effects.
A total of 174 patients will be included with 87 patients in each arm.
Primary endpoint is physical function reported by the patient after 3 months of treatment. The patients will assess their physical function by completing the EORTC QLQ-C30.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-reported outcomes arm (experimental arm) | Experimental | Device: Electronic patient-reported outcomes regarding symptoms and health-related quality of lifeThis arm will be assigned to intervention by weekly electronic reporting of symptoms and side effects in an app. A specifically developed alert-algorithm will in real-time guide the patient to adjust supportive care or contact the hospital. The reported symptoms are sent to the hospital to a healthcare professional - depending on the severity of the reported symptoms the healthcare professional can schedule a visit at the clinic. The patient will also receive a health-related quality of life questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) including the Physical Function domain in the app each month. Patient satisfaction regarding the patient-reported outcomes will be measured with the validated Patient-Reported Experience Measurement questionnaire at termination of participation. |
| Standard of care | No intervention | –This arm will continue standard procedure regarding side effect registration and handling. The patients will receive a health-related quality of life questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QOL-C30) at baseline, after 1, 3, and 6 months of participation in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with metastatic renal cell carcinoma
- Age ≥ 18 years
- Starting 1st or 2nd line treatment at enrolment
- Performance status (PS) ≤ 2
- Able to read Danish
Key exclusion criteria (5 listed)
- No smart phone
- Patient participating in other interventional studies. This is only relevant for studies that might interfere with the intervention. Cases of doubt will be settled by the protocol committee.
- Persons deprived of liberty or under guardianship or curators
- Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
- Earlier participation in PRORECECA (e.g. when changing from 1st to 2nd line of treatment)
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 |
|---|---|---|
| Electronic patient-reported outcomes regarding symptoms and health-related quality of lifeAlso: ePRO, Alert-algorithm, active patient-reported outcomes, Real-time guidance of patients when symptom reportingWeekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles. The supportive care (including drugs) is similar in the two treatment arms except for the use of electronic patient-reported outcomes. | Device | Patient-reported outcomes arm (experimental arm) |
Primary outcome
Physical function
Time frame: Within the first 3 months of treatment
Patient-reported physical function in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) - Whether patients using PRO experience a better physical function compared to patients receiving standard care and handling of side effects.
6 secondary outcomes
Health related quality of life
Time frame: Within the first 6 months of treatment
Admissions (number)
Time frame: Within the first 6 months of treatment
Admissions (length)
Time frame: Within the first 6 months of treatment
Symptom management (number)
Time frame: Within the first 6 months of treatment
Symptom management (type)
Time frame: Within the first 6 months of treatment
Number of contacts to the clinic
Time frame: Within the first 6 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- 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.
Ida Marie L Rasmussen, MD principal investigator
Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic patient-reported outcomes regarding symptoms and health-related quality of life in people with Metastatic Renal Cell Carcinoma and Kidney Cancer, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Nov 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Kirstine H Møller, MD, PhD (+4538683868, anne.kirstine.hundahl.moeller@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function (time frame: Within the first 3 months of treatment). 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 26 Nov 2021.