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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Cancer; Urologic Neoplasms; Metastatic Renal Cell Carcinoma; Urologic Cancer; Advanced Renal Cell Carcinoma; Kidney Neoplasm
• Intervention / Treatment: Device: Electronic patient-reported outcomes regarding symptoms and health-related quality of life

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 Type: Interventional
• Enrollment (Anticipated): 174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Kirstine H Møller, MD, PhD; Phone Number: +4538683868; Email: anne.kirstine.hundahl.moeller@regionh.dk
• Study Contact Backup: Name: Jesper A Palshof, MD, PhD; Phone Number: +4538683868; Email: jesper.andreas.palshof@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Department of Oncology, Herlev and Gentofte Hospital
    • Contact: Ida Marie L Rasmussen, MD; Phone Number: +45 38683868; Email: ida.marie.lind.rasmussen@regionh.dk
    • Contact: Anne Kirstine H Møller, MD, PhD; Phone Number: +45 3868 3868; Email: anne.kirstine.hundahl.moeller@regionh.dk
    • Principal Investigator: Ida Marie L Rasmussen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-reported outcomes arm (experimental arm); 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.	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.; Other Names: Real-time guidance of patients when symptom reporting; ePRO; Alert-algorithm; active patient-reported outcomes
No Intervention: Standard of care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Symptom management (number)	Registration of differences in number of intervention in the two treatment arms.	Within the first 6 months of treatment
Symptom management (type)	Registration of differences in types of intervention in the two treatment arms.	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.	Within the first 6 months of treatment

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Investigators: Principal Investigator: Ida Marie L Rasmussen, MD, Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 13, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Physical function; Patient-reported outcomes; Electronic reporting of symptoms
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Urologic Neoplasms
• Other Study ID Numbers: UR 2134; P-2021-693 (Other Identifier: Videnscenter for Dataanmeldelser / PACTIUS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No