Clinical trial NCT05135832: Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma
Official title: Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Physical function
timeFrame: Within the first 3 months of treatment
Secondary outcomes:
measure: Health related quality of life
timeFrame: Within the first 6 months of treatment
measure: Admissions (number)
timeFrame: Within the first 6 months of treatment
measure: Admissions (length)
timeFrame: Within the first 6 months of treatment
measure: Symptom management (number)
timeFrame: Within the first 6 months of treatment
measure: Symptom management (type)
timeFrame: Within the first 6 months of treatment
measure: Number of contacts to the clinic
timeFrame: Within the first 6 months of treatment
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Oncology, Herlev and Gentofte Hospital
Study officials:
affiliation: Herlev and Gentofte Hospital
name: Ida Marie L Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
References: