Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma

Kidney Cancer Clinical Trial

— PRORECECA  

Official title:

Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma; a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05135832
• Other study ID #: UR 2134
• Secondary ID: P-2021-693
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2021
• Source: Herlev and Gentofte Hospital
• Contact: Anne Kirstine H Møller, MD, PhD
• Phone: +4538683868
• Email: anne.kirstine.hundahl.moeller[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 174
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with metastatic renal cell carcinoma

2. Age = 18 years

3. Starting 1st or 2nd line treatment at enrolment

4. Performance status (PS) = 2

5. Able to read Danish

6. No serious cognitive impairment

7. Patient has given written informed consent

Exclusion Criteria:

1. No smart phone

2. 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.

3. Persons deprived of liberty or under guardianship or curators

4. 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

5. Earlier participation in PRORECECA (e.g. when changing from 1st to 2nd line of treatment)

Related Conditions & MeSH terms

• Advanced Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasm
• Kidney Neoplasms
• Metastatic Renal Cell Carcinoma
• Neoplasms
• Urologic Cancer
• Urologic Neoplasms

Intervention

Device:
• Electronic patient-reported outcomes regarding symptoms and health-related quality of life
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.

Locations

Country	Name	City	State
Denmark	Department of Oncology, Herlev and Gentofte Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within the first 3 months of treatment
Secondary	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).	Within the first 6 months of treatment
Secondary	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.	Within the first 6 months of treatment
Secondary	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.	Within the first 6 months of treatment
Secondary	Symptom management (number)	Registration of differences in number of intervention in the two treatment arms.	Within the first 6 months of treatment
Secondary	Symptom management (type)	Registration of differences in types of intervention in the two treatment arms.	Within the first 6 months of treatment
Secondary	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.	Within the first 6 months of treatment