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

Primary Purpose

Metastatic Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasm

Status
Not yet recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Electronic patient-reported outcomes regarding symptoms and health-related quality of life
Sponsored by
Herlev and Gentofte Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Renal Cell Carcinoma focused on measuring Patient-reported outcomes, Electronic reporting of symptoms, Physical function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Oncology, Herlev and Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient-reported outcomes arm (experimental arm)

Standard of care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
Symptom management (number)
Registration of differences in number of intervention in the two treatment arms.
Symptom management (type)
Registration of differences in types of intervention in the two treatment arms.
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.

Full Information

First Posted
October 27, 2021
Last Updated
November 15, 2021
Sponsor
Herlev and Gentofte Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05135832
Brief Title
Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma
Acronym
PRORECECA
Official Title
Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma; a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 13, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient-reported outcomes arm (experimental arm)
Arm Type
Experimental
Arm 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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Electronic patient-reported outcomes regarding symptoms and health-related quality of life
Other Intervention Name(s)
ePRO, Alert-algorithm, active patient-reported outcomes, Real-time guidance of patients when symptom reporting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical function
Description
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.
Time Frame
Within the first 3 months of treatment
Secondary Outcome Measure Information:
Title
Health related quality of life
Description
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).
Time Frame
Within the first 6 months of treatment
Title
Admissions (number)
Description
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.
Time Frame
Within the first 6 months of treatment
Title
Admissions (length)
Description
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.
Time Frame
Within the first 6 months of treatment
Title
Symptom management (number)
Description
Registration of differences in number of intervention in the two treatment arms.
Time Frame
Within the first 6 months of treatment
Title
Symptom management (type)
Description
Registration of differences in types of intervention in the two treatment arms.
Time Frame
Within the first 6 months of treatment
Title
Number of contacts to the clinic
Description
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.
Time Frame
Within the first 6 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Kirstine H Møller, MD, PhD
Phone
+4538683868
Email
anne.kirstine.hundahl.moeller@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper A Palshof, MD, PhD
Phone
+4538683868
Email
jesper.andreas.palshof@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ida Marie L Rasmussen, MD
Organizational Affiliation
Herlev and Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida Marie L Rasmussen, MD
Phone
+45 38683868
Email
ida.marie.lind.rasmussen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Anne Kirstine H Møller, MD, PhD
Phone
+45 3868 3868
Email
anne.kirstine.hundahl.moeller@regionh.dk
First Name & Middle Initial & Last Name & Degree
Ida Marie L Rasmussen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma

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