Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma (PRORECECA)

Herlev and Gentofte Hospital

Status: Unknown

Conditions: Metastatic Renal Cell Carcinoma; Urologic Cancer; Kidney Neoplasm; Advanced Renal Cell Carcinoma; Kidney Cancer; Urologic Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05135832

P-2021-693 (Other Identifier)

UR 2134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Patient-reported outcomes arm (experimental arm)

Experimental group

Description:

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.

Treatment:

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

Standard of care

No Intervention group

Description:

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.