Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma

NCT05135832 | Unknown

• 2 other identifiers: UR 2134P-2021-693
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Health related quality of life

  Within the first 6 months of treatment

• Admissions (number)

  Within the first 6 months of treatment

• Admissions (length)

  Within the first 6 months of treatment

• Symptom management (number)

  Within the first 6 months of treatment

• Symptom management (type)

  Within the first 6 months of treatment

Study Arms (2)

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.

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.

Interventions

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

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.

Also known as: ePRO, Alert-algorithm, active patient-reported outcomes, Real-time guidance of patients when symptom reporting

Patient-reported outcomes arm (experimental arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Department of Oncology, Herlev and Gentofte Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Urologic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Ida Marie L Rasmussen, MD

  Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Kirstine H Møller, MD, PhD

CONTACT

+4538683868; anne.kirstine.hundahl.moeller@regionh.dk

Jesper A Palshof, MD, PhD

CONTACT

+4538683868; jesper.andreas.palshof@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 26, 2021
• Study Start: December 13, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)